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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000540-26 | EudraCT Number | ||
| 2015L00219 | Other Identifier | National Medical Products Administration (China) |
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To assess the safety, tolerability and efficacy of two different doses of istaroxime, a new agent with lusitropic and inotropic activities that improves the cardiac contraction-relaxation cycle. The 2 doses of istaroxime (0.5 and 1.0 µg/kg/min) will be infused via i. v. for 24 hours in comparison with placebo, in treatment of Chinese and Italian patients with Acute Decompensated Heart Failure.
To assess the safety, tolerability and efficacy of two different doses of istaroxime (0.5 and 1.0 µg/kg/min) in comparison with placebo, including cardiovascular and renal tolerability, as well as changes in biological markers such as N-terminal prohormone brain natriuretic peptide (NT-proBNP) and troponin T (cTnT). The study will be conducted in 96 Chinese and Italian patients with Acute Decompensated Heart Failure. This is a phase II, multicenter, randomized, double-blind, placebo-controlled, parallel group study. Patients were randomly assigned to one of two doses of istaroxime or placebo in a 2:1 ratio within two sequential cohorts of 60 patients each. This 31-day study includes a screening period (Days -1), a treatment period (Day 1), a post-treatment period (Days 2-4), and a follow-up period (which includes one patient visit on Day 30).
In all the Italian patients and in a subset of Chinese patients pharmacokinetics and metabolism of istaroxime shall also be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | IV infusion of placebo for 24 hours |
|
| Istaroxime 0.5 µg/kg/min | Experimental | The istaroxime treatment dosed at 0.5 µg/kg/min via IV infusion for 24 hours |
|
| Istaroxime 1.0 µg/kg/min | Experimental | The istaroxime treatment dosed at 1.0 µg/kg/min via IV infusion for 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | IV of matching saline solution |
| |
| Istaroxime |
| Measure | Description | Time Frame |
|---|---|---|
| Change in E/Ea Ratio | Change from baseline at 24 hours in the unitless ratio of E (cm/sec) to Ea (or e') (cm/sec) as measured by echocardiogram. The endpoint is the Tissue Doppler echocardiography showing measurement of mitral E/Ea ratio for assessment of diastolic dysfunction. Initially mitral E wave is measured. After that, color Tissue Doppler (tissue velocity imaging or TVI) mode is switched on to assess tissue Doppler. The cursor is placed over the medial mitral annulus and tissue Doppler tracing obtained. This allows Ea velocity to be measured. Higher values are suggestive of a worse outcome; less than 8 is normal. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LVEF | Change from baseline at 24 hours in LV ejection fraction (LVEF) by tissue Doppler | 24 hours |
| Change in SVI | Change from baseline at 24 hours in stroke volume index (SVI) by tissue Doppler |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cTnT | Safety endpoint: Changes in troponin (cTnT) | 24 hours |
| Change in eGFR | Safety endpoint: Change from baseline in estimated glomerular filtration rate (eGFR) |
Inclusion Criteria:
Patients who fulfill the following inclusion criteria at screening will be considered for the study:
Exclusion Criteria:
Any of the following criteria established at screening would render a patient ineligible for the study:
Pregnant or breast-feeding women (women of child bearing potential must have the results of a negative pregnancy test recorded prior to study drug administration)
Current (within 12 hours prior to screening) or planned (through the completion of study drug infusion) treatment with any iv. therapies, including vasodilators (including nitrates or nesiritide), positive inotropic agents and vasopressors
Current or need of mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device),
Ongoing treatment with oral digoxin. Patient treated with digoxin within the last week, can be randomised if the plasma concentration of digoxin is tested before randomization and its value will be less than 0.5 ng/ml.
History of hypersensitivity to the study medication or any related medication
Diagnosis of cardiogenic shock within the past month;
Acute coronary syndrome or stroke within the past 3 months;
Coronary artery bypass graft or percutaneous coronary intervention within the past month or planned in the next month;
Primary hypertrophic or restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease;
Cor pulmonale or other causes of right-sided heart failure (HF) not related to left ventricular dysfunction;
Pericardial constriction or active pericarditis;
Atrial fibrillation with marked irregularities of heart rhythm;
Life threatening ventricular arrhythmia or implantable cardioverter-defibrillator (ICD) shock within the past month;
Cardiac resynchronization therapy (CRT), ICD, or pacemaker implantation within the past month;
Valvular disease as primary cause of HF;
Heart rate >120 bpm or < 50 bpm
Acute respiratory distress syndrome or ongoing sepsis;
Fever >38°
History of bronchial asthma or porphyria;
Donation or loss of blood equal to or exceeding 500 mL, during the 8 weeks before administration of study medication;
Positive testing for HIV, Hepatitis B and/or Hepatitis C;
Participation in another interventional study within the past 30 days;
The following laboratory exclusion criteria, verified based on results obtained within the last 24 hours of hospitalization:
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| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Bianchi, MD | Windtree Therapeutics, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lanzhou University No.2 Hospital | Lanzhou | Gansu | China | |||
| The First Hospital of Lanzhou University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31975496 | Result | Carubelli V, Zhang Y, Metra M, Lombardi C, Felker GM, Filippatos G, O'Connor CM, Teerlink JR, Simmons P, Segal R, Malfatto G, La Rovere MT, Li D, Han X, Yuan Z, Yao Y, Li B, Lau LF, Bianchi G, Zhang J; Istaroxime ADHF Trial Group. Treatment with 24 hour istaroxime infusion in patients hospitalised for acute heart failure: a randomised, placebo-controlled trial. Eur J Heart Fail. 2020 Sep;22(9):1684-1693. doi: 10.1002/ejhf.1743. Epub 2020 Jan 23. |
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Screening to assess whether the patient qualified for the study. 144 patients were screened, 22 were determined to be screen failures and additional 2 patients were excluded for not meeting inclusion/exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | IV infusion for 24 hours Placebo: IV of matching saline solution |
| FG001 | Istaroxime 0.5 µg/kg/Min | Istaroxime via IV infusion for 24 hours Istaroxime: IV infusion of istaroxime 0.5 µg/kg/min |
| FG002 | Istaroxime 1.0 µg/kg/Min | Istaroxime via IV infusion for 24 hours Istaroxime: IV infusion of istaroxime 1.0 µg/kg/min |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-Treat
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | IV infusion for 24 hours Placebo: IV of matching saline solution |
| BG001 | Istaroxime 0.5 µg/kg/Min | Istaroxime via IV infusion for 24 hours Istaroxime: IV infusion of istaroxime 0.5 µg/kg/min |
| 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 in E/Ea Ratio | Change from baseline at 24 hours in the unitless ratio of E (cm/sec) to Ea (or e') (cm/sec) as measured by echocardiogram. The endpoint is the Tissue Doppler echocardiography showing measurement of mitral E/Ea ratio for assessment of diastolic dysfunction. Initially mitral E wave is measured. After that, color Tissue Doppler (tissue velocity imaging or TVI) mode is switched on to assess tissue Doppler. The cursor is placed over the medial mitral annulus and tissue Doppler tracing obtained. This allows Ea velocity to be measured. Higher values are suggestive of a worse outcome; less than 8 is normal. | Intent-to-Treat | Posted | Least Squares Mean | 95% Confidence Interval | Unitless ratio | 24 hours |
|
Enrollment to 30 days after enrollment
Participants were closely supervised in a hospital. Adverse events were observed by study staff and reported by participants.
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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 | IV infusion for 24 hours Placebo: IV of matching saline solution | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA, v16.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrythmia | Cardiac disorders | MedDRA, v16.0 | Non-systematic Assessment |
The major limitation of this study regards enrollment discrepancies between the study populations and sites of the two cohorts, with Cohort 2 enrolling exclusively Asian patients. We observed that patients enrolled in this trial were younger and with a better renal function compared to other studies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip D. Simmons, Executive Director of Biostatistics & Data Management | Windtree Therapeutics, Inc. | 215-488-9300 | psimmons@windtreetx.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 17, 2018 | Jan 23, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 30, 2018 | Jan 23, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 18, 2017 | Mar 28, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| C468128 | Istaroxime |
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Cohort I: Participants enrolled in a 2:1 ratio to istaroxime 0.5 µg/kg/min or placebo.
Cohort II: Participants enrolled in a 2:1 ratio to istaroxime 1.0 µg/kg/min or placebo.
Cohort I was enrolled first, followed by Cohort II.
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Double-blind
| Drug |
IV infusion of 0.5 µg/kg/min or 1.0 µg/kg/min istaroxime |
|
| 24 hours |
| Change in E/A Ratio | Change from baseline at 24 hours in E/A ratio by tissue Doppler | 24 hours |
| Change in LV End Systolic Volume | Change from baseline in left ventricular end systolic volume (LVESV) by tissue Doppler | 24 hours |
| Change in LV End Diastolic Volume | Change from baseline in left ventricular end diastolic volume (LVEDV) by tissue Doppler | 24 hours |
| Change in Dyspnea | Measured using a visual analog scale (0 to 100). Higher scores indicate less dyspnea. | 24 hours |
| 24 Hours |
| Participants With Clinically or Hemodynamically Significant Episodes of Arrhythmias | Safety endpoint: Number of participants with incidence of clinically or hemodynamically significant episodes of supraventricular or ventricular arrhythmias detected by continuous ECG dynamic monitoring | 24 hours |
| PR Interval | Safety Endpoint: The PR interval, measured in milliseconds, extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex (the onset of ventricular depolarization). | 24 Hours |
| QRS Duration | Safety endpoint: The quasi-random signal (QRS) duration represents the time for ventricular depolarization, normally 0.06 to 0.10 seconds. | 24 hours |
| QTc Interval | Safety Endpoint: The corrected QT interval (QTc) on an ECG represents the duration in milliseconds of the ventricular action potential, which physiologically correlates with the duration of the ventricular depolarization and repolarization. | 24 Hours |
| All-Cause Mortality at Day 30 | Safety endpoint: Mortality at Day 30 | 30 days |
| RBC - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in red blood cells (RBC) | Day 3 |
| Hematocrit - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in hematocrit | Day 3 |
| Hemoglobin - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in hemoglobin | Day 3 |
| White Blood Cells (WBC) - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in WBC | Day 3 |
| Platelets - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in platelets | Day 3 |
| Potassium - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in potassium | Day 3 |
| Sodium - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in sodium | Day 3 |
| Calcium - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in calcium | Day 3 |
| BUN - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in blood urea nitrogen (BUN) | Day 3 |
| ALT - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in alanine aminotransferase (ALT) | Day 3 |
| AST - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in aspartate aminotransferase (AST) | Day 3 |
| Total Bilirubin - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in total bilirubin | Day 3 |
| Lanzhou |
| Gansu |
| China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | China |
| Jiangsu Province People's Hospital | Nanjing | Jiangsu | China |
| The General Hospital Of Shenyang Military Region | Shenyang | Liaoning | China |
| The First Affiliated Hospital Of Xi'an Jiaotong University | Xi'an | Shaanxi | China |
| Fuwai Hospital Chinese Academy of Medical Sciences | Beijing | 100037 | China |
| Beijing Chao Yang Hospital | Beijing | China |
| The 307th Hospital of Chinese People's Liberation Army | Beijing | China |
| University and Civil Hospital of Brescia | Brescia | Italy |
| University of Milano-Bicocca | Milan | Italy |
| Lost to Follow-up |
|
| Death |
|
| BG002 | Istaroxime 1.0 µg/kg/Min | Istaroxime via IV infusion for 24 hours Istaroxime: IV infusion of istaroxime 1.0 µg/kg/min |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| E/Ea Ratio | Unitless ratio of E (cm/sec) to Ea (cm/sec) as measured by echocardiogram. The endpoint is the Tissue Doppler echocardiography showing measurement of mitral E/e' ratio for assessment of diastolic dysfunction. Initially mitral E wave is measured. After that, color Tissue Doppler (tissue velocity imaging or TVI) mode is switched on to assess tissue Doppler. The cursor is placed over the medial mitral annulus and tissue Doppler tracing obtained. This allows e' velocity to be measured. Higher values are suggestive of a worse outcome; less than 8 is normal. | Measurements for 1 istaroxime 0.5 µg/kg/min participant not recorded (missing). | Mean | Standard Deviation | Unitless ratio |
|
| Left ventricular ejection fraction (LVEF) | LVEF (% blood ejected from heart) as measured by echocardiogram | Measurements for 4 participants (1 placebo participant, 1 istaroxime 0.5 µg/kg/min participant, 2 istaroxime 1.0 µg/kg/min participants) not recorded (missing) | Mean | Standard Deviation | % of blood in heart pumped |
|
| Stroke Volume Index | Stroke volume index (SVI) as measured by echocardiogram | Measurements for 2 participants (1 istaroxime 0.5 µg/kg/min participant, 1 istaroxime 1.0 µg/kg/min participant) not recorded (missing) | Mean | Standard Deviation | ml/m² |
|
| Dyspnea | Scores on a scale using Visual Analog Scales (VAS). Scores range from 0 to 100, with higher values indicating a better outcome (less dyspnea). | Mean | Standard Deviation | Scores on a scale |
|
| Troponin (cTnT) | Cardiac muscle troponin T (cTnT) measured as ng/L | Mean | Standard Deviation | ng/L |
|
| eGFR | Estimated glomerular filtration rate (eGFR), measured as ml/min/1.73·m² | Measurements for 1 istaroxime 0.5 µg/kg/min participant not recorded (missing) | Mean | Standard Deviation | ml/min/1.73·m² |
|
| OG001 |
| Placebo Cohort I |
Placebo participants enrolled in Cohort I |
| OG002 | Istaroxime 1.0 µg/kg/Min | Istaroxime participants receiving 1.0 µg/kg/min (Cohort II) |
| OG003 | Placebo Cohort II | Placebo participants enrolled in Cohort II |
|
|
|
| Secondary | Change in LVEF | Change from baseline at 24 hours in LV ejection fraction (LVEF) by tissue Doppler | Intent-to-Treat | Posted | Mean | 95% Confidence Interval | % of blood leaving the heart | 24 hours |
|
|
|
|
| Secondary | Change in SVI | Change from baseline at 24 hours in stroke volume index (SVI) by tissue Doppler | Intent-to-Treat | Posted | Least Squares Mean | 95% Confidence Interval | mL/m² | 24 hours |
|
|
|
|
| Secondary | Change in E/A Ratio | Change from baseline at 24 hours in E/A ratio by tissue Doppler | Intent-to-Treat | Posted | Least Squares Mean | 95% Confidence Interval | Unitless ratio | 24 hours |
|
|
|
|
| Secondary | Change in LV End Systolic Volume | Change from baseline in left ventricular end systolic volume (LVESV) by tissue Doppler | Intent-to-Treat | Posted | Least Squares Mean | 95% Confidence Interval | mL | 24 hours |
|
|
|
|
| Secondary | Change in LV End Diastolic Volume | Change from baseline in left ventricular end diastolic volume (LVEDV) by tissue Doppler | Intent-to-Treat | Posted | Least Squares Mean | 95% Confidence Interval | mL | 24 hours |
|
|
|
|
| Secondary | Change in Dyspnea | Measured using a visual analog scale (0 to 100). Higher scores indicate less dyspnea. | Intent-to-Treat | Posted | Mean | Standard Deviation | Score on a scale (Visual Analog Scale) | 24 hours |
|
|
|
|
| Other Pre-specified | Change in cTnT | Safety endpoint: Changes in troponin (cTnT) | Intent-to-Treat | Posted | Mean | Standard Deviation | ng/L | 24 hours |
|
|
|
| Other Pre-specified | Change in eGFR | Safety endpoint: Change from baseline in estimated glomerular filtration rate (eGFR) | Safety Population | Posted | Mean | Standard Deviation | ml/min/1.73·m² | 24 Hours |
|
|
|
| Other Pre-specified | Participants With Clinically or Hemodynamically Significant Episodes of Arrhythmias | Safety endpoint: Number of participants with incidence of clinically or hemodynamically significant episodes of supraventricular or ventricular arrhythmias detected by continuous ECG dynamic monitoring | Safety Population | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Other Pre-specified | PR Interval | Safety Endpoint: The PR interval, measured in milliseconds, extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex (the onset of ventricular depolarization). | Safety Population | Posted | Mean | Standard Deviation | msec | 24 Hours |
|
|
|
| Other Pre-specified | QRS Duration | Safety endpoint: The quasi-random signal (QRS) duration represents the time for ventricular depolarization, normally 0.06 to 0.10 seconds. | Safety Population | Posted | Mean | Standard Deviation | msec | 24 hours |
|
|
|
| Other Pre-specified | QTc Interval | Safety Endpoint: The corrected QT interval (QTc) on an ECG represents the duration in milliseconds of the ventricular action potential, which physiologically correlates with the duration of the ventricular depolarization and repolarization. | Safety Population | Posted | Mean | Standard Deviation | msec | 24 Hours |
|
|
|
| Other Pre-specified | All-Cause Mortality at Day 30 | Safety endpoint: Mortality at Day 30 | Intent-to-Treat | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Other Pre-specified | RBC - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in red blood cells (RBC) | Safety Population | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Other Pre-specified | Hematocrit - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in hematocrit | Safety Population | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Other Pre-specified | Hemoglobin - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in hemoglobin | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Other Pre-specified | White Blood Cells (WBC) - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in WBC | Safety Population | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Other Pre-specified | Platelets - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in platelets | Safety Population | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Other Pre-specified | Potassium - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in potassium | Safety Population | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Other Pre-specified | Sodium - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in sodium | Safety Population | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Other Pre-specified | Calcium - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in calcium | Safety Population | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Other Pre-specified | BUN - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in blood urea nitrogen (BUN) | Safety Population | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Other Pre-specified | ALT - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in alanine aminotransferase (ALT) | Safety Population | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Other Pre-specified | AST - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in aspartate aminotransferase (AST) | Safety Population | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Other Pre-specified | Total Bilirubin - Shift | Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in total bilirubin | Safety Population | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| 39 |
| 2 |
| 39 |
| 23 |
| 39 |
| EG001 | Istaroxime 0.5 µg/kg/Min | Istaroxime via IV infusion for 24 hours Istaroxime: IV infusion of istaroxime 0.5 µg/kg/min | 0 | 41 | 2 | 41 | 31 | 41 |
| EG002 | Istaroxime 1.0 µg/kg/Min | Istaroxime via IV infusion for 24 hours Istaroxime: IV infusion of istaroxime 1.0 µg/kg/min | 2 | 40 | 6 | 40 | 33 | 40 |
| Cardiac failure congestive | Cardiac disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Cardiac death | General disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Renal embolism | Renal and urinary disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA, v16.0 | Non-systematic Assessment | Includes "Implant site pain", "Infusion site pain", and "Injection site pain" |
|
| Oedema peripheral | General disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA, v16.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA, v16.0 | Non-systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA, v16.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA, v16.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA, v16.0 | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA, v16.0 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA, v16.0 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA, v16.0 | Non-systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA, v16.0 | Non-systematic Assessment |
|
| Electrocardiogram T wave inversion | Investigations | MedDRA, v16.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA, v16.0 | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA, v16.0 | Non-systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA, v16.0 | Non-systematic Assessment |
|
All data and results of the clinical study are possessed by sponsor and investigator. Investigator agrees not to submit the results of this study for publication or presentation before the sponsor review the accuracy and no leakage of confidential information in the manuscript.
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
Null hypothesis: No difference in LVEF % between istaroxime and placebo participants. |
| ANOVA |
Treatment term included in the model |
| 0.423 |
Alpha set at 0.05. No adjustment for multiple comparisons |
| Mean Difference (Final Values) |
| 0.9848 |
| 2-Sided |
| 95 |
| -1.4668 |
| 3.4365 |
| Superiority |
Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants. |
| ANOVA |
Treatment term is in the model |
| 0.090 |
Alpha set at 0.05. No adjustment for multiple comparisons |
| Mean Difference (Final Values) |
| 2.310 |
| 2-Sided |
| 95 |
| -0.373 |
| 4.992 |
| Superiority |
Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants. |
| ANOVA |
Treatment term is in the model |
| 0.029 |
Alpha set at 0.05. No adjustment for multiple comparisons |
| Mean Difference (Final Values) |
| -0.829 |
| 2-Sided |
| 95 |
| -1.568 |
| -0.091 |
| Superiority |
Null hypothesis: No difference in LVEDV between istaroxime and placebo participants. |
| ANOVA |
Treatment term is in the model |
| 0.931 |
Alpha set at 0.05. No adjustment for multiple comparisons |
| Mean Difference (Final Values) |
| 0.439 |
| 2-Sided |
| 95 |
| -9.735 |
| 10.614 |
| Superiority |
Null hypothesis: No difference in E to A ratio between istaroxime and placebo participants. |
| ANOVA |
Treatment term is in the model. |
| 0.424 |
Alpha set at 0.05. No adjustment for multiple comparisons |
| Mean Difference (Final Values) |
| 3.944 |
| 2-Sided |
| 95 |
| -5.886 |
| 13.774 |
| Superiority |
| Null hypothesis: no difference between treatment groups. | Mixed Models Analysis | Kenward-Roger adjustment used for the degrees of freedom. | 0.251 | Unadjusted alpha of 0.05 is the threshold for statistical significance. | Mean Difference (Final Values) | 3.015 | 2-Sided | 95 | -2.168 | 8.198 | Superiority | Linear mixed model with treatment, center, timepoint, gender, baseline cTnT value, atrial fibrillation, and treatment*timepoint interaction included in the model. |
| Title | Measurements |
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| Abnormal to Normal |
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| Abnormal to Abnormal |
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| Abnormal to Normal |
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| Abnormal to Abnormal |
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