Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022579-68 | EudraCT Number | ||
| COR-1/02 |
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The purpose of this study is to investigate the effect of COR-1 in combination with standard therapy in patients with heart failure. The safety and tolerability of COR-1 will also be assessed.
In patients with dilated cardiomyopathy (heart is weakened and enlarged), the presence of anti-beta1-receptor autoantibodies has been shown to predict more depressed left ventricular function, increased prevalence of serious ventricular arrhythmias, sudden cardiac death, and cardiovascular mortality. In animal models, COR-1 cyclopeptide has been shown to bind to, and therefore decrease, the anti-beta1-receptor autoantibody titre. This study will investigate the safety and effectiveness of COR-1 treatment in patients with dilated cardiomyopathy. This study will be a randomized (the study treatment is assigned by chance), double-blind, (neither investigator nor patient knows the treatment that the volunteer receives), multicenter (study is conducted in more than one center) placebo-controlled (one of the treatments is inactive), parallel group study (patients in different treatment groups receive medication at the same time) in men and women who have heart failure due to dilated cardiomyopathy. Eligible patients should also have a left ventricular ejection fraction of less than or equal to 45% (measurement of the percentage of blood leaving the heart each time it contracts) and should be positive for anti-beta1-receptor autoantibodies. The study will consist of 3 phases: a screening phase, a double-blind treatment period, and a follow-up phase. Patients will be randomly assigned to 1 of 4 treatment groups: 20 mg COR-1, 80 mg COR-1, 160 mg COR-1, or placebo (inactive medication). Each patient will receive 1 intravenous dose (medication is injected into a vein) every 4 weeks for a total of 6 months. Patients will come to the study center each time they receive study medication and will remain at the center for 2 to 3 hours following the injection. Blood samples will be drawn at time points during the screening, treatment, and follow-up periods. Patients will return to the study center for follow-up visits at 3 months following completion of the 6-month treatment period. Patients will participate in the study for approximately 9 months. Patient safety will be monitored. The study drug (COR-1) is being investigated for the treatment of heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| 20 mg COR-1 | Experimental |
| |
| 80 mg COR-1 | Experimental |
| |
| 160 mg COR-1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9 % sodium chloride | Drug | Monthly intravenous injection for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 | The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (central assessment). | Baseline and Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9 | The LVEF is a measure of how much blood is pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (local assessment). | Baseline and Month 9 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Corimmun GmbH Clinical Trial | Corimmun GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| München | Germany | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9950662 | Background | Jahns R, Boivin V, Siegmund C, Inselmann G, Lohse MJ, Boege F. Autoantibodies activating human beta1-adrenergic receptors are associated with reduced cardiac function in chronic heart failure. Circulation. 1999 Feb 9;99(5):649-54. doi: 10.1161/01.cir.99.5.649. | |
| 16996841 | Background | Stork S, Boivin V, Horf R, Hein L, Lohse MJ, Angermann CE, Jahns R. Stimulating autoantibodies directed against the cardiac beta1-adrenergic receptor predict increased mortality in idiopathic cardiomyopathy. Am Heart J. 2006 Oct;152(4):697-704. doi: 10.1016/j.ahj.2006.05.004. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. |
| FG001 | COR-1 20 Milligram (mg) | COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. |
| FG002 | COR-1 80 mg | COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. |
| FG003 | COR-1 160 mg | COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intention-to-treat (ITT) population included all participants who were randomly assigned to treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. |
| BG001 | COR-1 20 Milligram (mg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 6 | The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (central assessment). | Intention-to-treat (ITT) population included all participants who were randomly assigned to treatment. Missing data was imputed using last observation carried forward (LOCF) method. | Posted | Mean | Standard Deviation | Percentage of blood pumped out | Baseline and Month 6 |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure | Cardiac disorders | MedDRA Version 16.0E | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA Version 16.0E | Non-systematic Assessment |
Due to the decision to amend protocol to a pilot study coupled with the high study agent discontinuation rate, safety or efficacy of JNJ-54452840 could not be concluded due to the insufficient sample size and drug exposure to investigational agent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director Biostatistics | Janssen Research & Development, LLC | ClinicalTrialDisclosure@its.jnj.com |
Not provided
| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
Not provided
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
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| COR-1 |
| Drug |
Monthly intravenous injection for 6 months |
|
| Standard therapy for heart failure | Drug | All patients will continue to receive standard therapy for heart failure (ie, in accordance with guidelines) throughout the study. |
|
| Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6 | The NT-ProBNP is a biomarker (a biologic molecule) that has been shown to predict cardiac events. | Baseline and Month 6 |
| Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6 | Transmitral flow VTI measures how blood flows through the heart. This was measured by echocardiogram. Most of the values for transmitral flow VTI were not provided in the reports from central core echocardiographic laboratory due to technical reasons. | Baseline and Month 6 |
| Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6 | Tissue doppler mitral annular velocity is a measure of how well the heart fills with blood. This was measured by echocardiogram. Most of the values for E-wave were not provided in the reports from central core echocardiographic laboratory due to technical reasons. | Baseline and Month 6 |
| Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6 | A standardized 6-minute walk test was performed and the distance covered in 6 minutes was measured. | Baseline and Month 6 |
| Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Disease progression (morbidity) was measured by the NYHA classification. The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of 4 stages. Stage I- No symptoms/limitation in ordinary physical activity (for example, shortness of breath when walking, climbing stairs); Stage II-Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Stage III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity, (for example, walking short distances [20-100 m]), comfortable only at rest; and Stage IV- Severe limitations in activity/experiences symptoms while at rest (mostly bedbound participants). | Baseline and Month 6 |
| Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6 | Minnesota living with heart failure questionnaire is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses participant's perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Participants responded to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. | Baseline and Month 6 |
| Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Mean heart rate, maximum heart rate and minimum heart rate were evaluated. | Baseline and Month 6 |
| Number of Participants With Holter Electrocardiography (ECG) Parameters | A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Block, Heart rhythm, AV junctional, Ventricular, Lown classification, Results were evaluated. | Baseline and Month 6 |
| Regensburg |
| Germany |
| Tübingen | Germany |
| Würzburg | Germany |
| 11216956 | Background | Iwata M, Yoshikawa T, Baba A, Anzai T, Mitamura H, Ogawa S. Autoantibodies against the second extracellular loop of beta1-adrenergic receptors predict ventricular tachycardia and sudden death in patients with idiopathic dilated cardiomyopathy. J Am Coll Cardiol. 2001 Feb;37(2):418-24. doi: 10.1016/s0735-1097(00)01109-8. |
| 19171871 | Background | Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):480-6. doi: 10.1161/CIRCULATIONAHA.108.191259. No abstract available. |
| Adverse Event |
|
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Protocol Violation |
|
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
| BG002 | COR-1 80 mg | COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. |
| BG003 | COR-1 160 mg | COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| COR-1 20 Milligram (mg) |
COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. |
| OG002 | COR-1 80 mg | COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. |
| OG003 | COR-1 160 mg | COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. |
|
|
| Secondary | Change From Baseline in Local Left Ventricular Ejection Fraction (LVEF) at Month 9 | The LVEF is a measure of how much blood is pumped out of the left ventricle of the heart (the main pumping chamber). Ejection fraction percentages greater than (>) 55% are considered normal. It was measured by biplane echocardiography (local assessment). | ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. | Posted | Mean | Standard Deviation | Percentage of blood pumped out | Baseline and Month 9 |
|
|
|
| Secondary | Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-ProBNP) Level at Month 6 | The NT-ProBNP is a biomarker (a biologic molecule) that has been shown to predict cardiac events. | ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. | Posted | Mean | Standard Deviation | Picogram (pg)/ Milliliter (mL) | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Central Transmitral Flow Velocity Time Integral (VTI) at Month 6 | Transmitral flow VTI measures how blood flows through the heart. This was measured by echocardiogram. Most of the values for transmitral flow VTI were not provided in the reports from central core echocardiographic laboratory due to technical reasons. | ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. No participants were evaluable for arms COR-1 80 mg and COR-1 160 mg. | Posted | Mean | Standard Deviation | Centimeter (cm) | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Central Tissue E-Wave Doppler Mitral Annular Velocity at Month 6 | Tissue doppler mitral annular velocity is a measure of how well the heart fills with blood. This was measured by echocardiogram. Most of the values for E-wave were not provided in the reports from central core echocardiographic laboratory due to technical reasons. | ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Centimeter (cm)/ Second (sec) | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Distance Walked During Six-minute Walk Test at Month 6 | A standardized 6-minute walk test was performed and the distance covered in 6 minutes was measured. | ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. | Posted | Mean | Standard Deviation | Meter | Baseline and Month 6 |
|
|
|
| Secondary | Number of Participants With New York Heart Association (NYHA) Classification of Disease Progression | Disease progression (morbidity) was measured by the NYHA classification. The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of 4 stages. Stage I- No symptoms/limitation in ordinary physical activity (for example, shortness of breath when walking, climbing stairs); Stage II-Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity; Stage III- Marked limitation in activity due to symptoms, even during less-than-ordinary activity, (for example, walking short distances [20-100 m]), comfortable only at rest; and Stage IV- Severe limitations in activity/experiences symptoms while at rest (mostly bedbound participants). | ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point. | Posted | Number | Participants | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Minnesota Living With Heart Failure Questionnaire Score at Month 6 | Minnesota living with heart failure questionnaire is a self-administered, disease-specific measure of health related quality of life (QOL) that assesses participant's perceptions of the influence of heart failure on physical, socioeconomic and psychological aspects of life. Participants responded to 21 items using a six-point response scale (0-5). The total summary score can range from 0-105 with a lower score reflecting better heart failure related QOL. | ITT population included all participants who were randomly assigned to treatment. Missing data was imputed using LOCF method. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Month 6 |
|
|
|
| Secondary | Change From Baseline in Holter Electrocardiography (ECG) Parameters (Heart Rate) at Month 6 | A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Mean heart rate, maximum heart rate and minimum heart rate were evaluated. | Safety population included all participants who received at least 1 dose of the study agent. | Posted | Mean | Standard Deviation | Beats per minute | Baseline and Month 6 |
|
|
|
| Secondary | Number of Participants With Holter Electrocardiography (ECG) Parameters | A Holter monitor is a portable device which monitors the electrical activity (electrocardiography) of the heart. Block, Heart rhythm, AV junctional, Ventricular, Lown classification, Results were evaluated. | Safety population included all participants who received at least 1 dose of the study agent. | Posted | Number | Participants | Baseline and Month 6 |
|
|
|
| 1 |
| 10 |
| 4 |
| 10 |
| EG001 | COR-1 20 Milligram (mg) | COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. | 1 | 8 | 7 | 8 |
| EG002 | COR-1 80 mg | COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. | 1 | 6 | 5 | 6 |
| EG003 | COR-1 160 mg | COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses. | 6 | 12 | 6 | 12 |
| Cardiogenic Shock | Cardiac disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Heart Valve Incompetence | Cardiac disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Sinus Arrest | Cardiac disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Cardiac Death | General disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Lobar Pneumonia | Infections and infestations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Ejection Fraction Decreased | Investigations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Weight Increased | Investigations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Loss of Consciousness | Nervous system disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Mental Disorder | Psychiatric disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Haemodialysis | Surgical and medical procedures | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Ventricular Extrasystoles | Cardiac disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Anal Inflammation | Gastrointestinal disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Chest Pain | General disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| General Physical Health Deterioration | General disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Injection Site Haematoma | General disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Acute Tonsillitis | Infections and infestations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Oral Herpes | Infections and infestations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Staphylococcal Infection | Infections and infestations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Face Injury | Injury, poisoning and procedural complications | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Traumatic Haematoma | Injury, poisoning and procedural complications | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Blood Creatine Increased | Investigations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Blood Potassium Increased | Investigations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Blood Pressure Decreased | Investigations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Carotid Bruit | Investigations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Glomerular Filtration Rate Abnormal | Investigations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Heart Rate Increased | Investigations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Hepatic Enzyme Increased | Investigations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Prostatic Specific Antigen Increased | Investigations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Weight Increased | Investigations | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Aura | Nervous system disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Mental Disorder | Psychiatric disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Renal Impairment | Renal and urinary disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Wisdom Teeth Removal | Surgical and medical procedures | MedDRA Version 16.0E | Non-systematic Assessment |
|
| Venous Insufficiency | Vascular disorders | MedDRA Version 16.0E | Non-systematic Assessment |
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If Sponsor should have justified objections, then Hospital will respond to these objections as the scientific nature of publication are not negatively affected. If no agreement can be reached, they will appeal to an independent body of experts to resolve the points in dispute. It is not permissible to publish study data before overall study results are published without the written consent of Sponsor. However, this applies to a maximum period of 12 months after study has ended or been cancelled.
| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017670 |
| Sodium Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| Change at Month 9 |
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| Change at Month 6 |
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| Change at Month 6 |
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| Change at Month 6 |
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| Baseline: Stage III (n= 10, 8, 6, 12) |
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| Month 6: Stage I (n= 7, 7, 5, 8) |
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| Month 6: Stage II (n= 7, 7, 5, 8) |
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| Month 6: Stage III (n= 7, 7, 5, 8) |
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| Change at Month 6 |
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| Change at Month 6: Mean Heart Rate |
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| Baseline: Maximum Heart Rate |
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| Change at Month 6: Maximum Heart Rate |
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| Baseline: Minimum Heart Rate |
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| Change at Month 6: Minimum Heart Rate |
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| Baseline: AV block I |
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| Baseline: AV block II |
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| Baseline: AV block III |
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| Baseline: Sinus rhythm |
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| Baseline: Atrial fibrillation |
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| Baseline:Atrial fibrillation-paroxysmal/persistent |
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| Baseline: Other |
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| Baseline; AV junctional, 0-240/24h |
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| Baseline: AV junctional, 241-1000/24h |
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| Baseline: AV junctional, 1001-2400/24h |
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| Baseline: Ventricular, 0-240/24h |
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| Baseline: Ventricular, 241-1000/24h |
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| Baseline: Ventricular, 1001-2400/24h |
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| Baseline: 0 No VES |
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| Baseline: I Occasional individual VES (< 30/h) |
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| Baseline: II Frequent VES (>30/h) |
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| Baseline: IIIa Polymorphous VES |
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| Baseline: IIIb Ventricular bigeminy |
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| Baseline: IVa Couplets, repetitive VES |
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| Baseline: IVb Runs, repetitive VES |
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| Baseline: V Early occurring VES(R-on T phenomenon) |
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| Baseline: II, IIIa, IVa, IVb |
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| Baseline: Normal |
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| Baseline: Abnormal, NCS |
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| Baseline: Abnormal, CS |
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| Month 6: No block |
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| Month 6: AV block I |
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| Month 6: AV block II |
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| Month 6: AV block III |
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| Month 6: Sinus rhythm |
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| Month 6: Atrial fibrillation |
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| Month 6: Atrial fibrillation-paroxysmal/persistent |
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| Month 6: Other |
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| Month 6: AV junctional, 0-240/24h |
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| Month 6: AV junctional, 241-1000/24h |
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| Month 6: AV junctional, 1001-2400/24h |
|
| Month 6: Ventricular, 0-240/24h |
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| Month 6: Ventricular, 241-1000/24h |
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| Month 6: Ventricular, 1001-2400/24h |
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| Month 6: 0 No VES |
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| Month 6: I Occasional individual VES (< 30/h) |
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| Month 6: II Frequent VES (>30/h) |
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| Month 6: IIIa Polymorphous VES |
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| Month 6: IVa Couplets, repetitive VES |
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| Month 6: IVb Runs, repetitive VES |
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| Month 6: V Early occurring VES (R-on T phenomenon) |
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| Month 6: II, IIIa, IVa, IVb |
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| Month 6: Normal |
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| Month 6: Abnormal, NCS |
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| Month 6: Abnormal, CS |
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