Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| University of Maryland | OTHER |
| Gilead Sciences | INDUSTRY |
Not provided
Not provided
Not provided
This study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension therapies but with right ventricular dysfunction (RVEF <45%) will improve their health by improving right ventricular (RV) function.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Active Comparator | Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day |
|
| Placebo | Placebo Comparator | Placebo by mouth twice per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | Ranolazine 500mg by mouth twice per day and after two weeks increases to 1000mg by mouth twice per day and continue for a total of 26 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage) | Change in right ventricle ejection fraction as assessed by MRI | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in 6min-walk-test Distance | 6-minute walk test | 6 months |
| Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) | NT-proBNP measured at 6-months compared to baseline |
Not provided
Inclusion Criteria:
Symptomatic pulmonary hypertension based on one of the following criteria:
World Health Organization functional class II, III, or IV
Mean pulmonary artery pressure >25 mmHg at rest
Pulmonary capillary wedge pressure or left ventricular end diastolic pressure < 15 mmHg
Pulmonary vascular resistance > 3 mmHg/L/min
Right ventricle ejection fraction < 45%
6-minute walk test distance > 50 meters
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yuchi Han, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland | Baltimore | Maryland | 21201 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29531764 | Derived | Han Y, Forfia PR, Vaidya A, Mazurek JA, Park MH, Ramani G, Chan SY, Waxman AB. Rationale and design of the ranolazine PH-RV study: a multicentred randomised and placebo-controlled study of ranolazine to improve RV function in patients with non-group 2 pulmonary hypertension. Open Heart. 2018 Feb 23;5(1):e000736. doi: 10.1136/openhrt-2017-000736. eCollection 2018. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine | Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day Ranolazine: Ranolazine 500mg by mouth twice per day and after two weeks increases to 1000mg by mouth twice per day and continue for a total of 26 weeks. |
| FG001 | Placebo | Placebo by mouth twice per day Placebo: Placebo by mouth twice per day for a total of 26 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ranolazine | Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day Ranolazine: Ranolazine 500mg by mouth twice per day and after two weeks increases to 1000mg by mouth twice per day and continue for a total of 26 weeks. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage) | Change in right ventricle ejection fraction as assessed by MRI | participants who completed follow up study at 6 months. | Posted | Least Squares Mean | Standard Error | percentage | 26 weeks |
|
7 months including 6 months of drug treatment and 1 month post treatment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranolazine | Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day Ranolazine: Ranolazine 500mg by mouth twice per day and after two weeks increases to 1000mg by mouth twice per day and continue for a total of 26 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| heart failure | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yuchi Han, PI of the study | University of Pennsylvania | 215-615-3417 | yuchi.han@uphs.upenn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2016 | Nov 29, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo by mouth twice per day for a total of 26 weeks |
|
| 6 months |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Placebo by mouth twice per day Placebo: Placebo by mouth twice per day for a total of 26 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percent Change in 6min-walk-test Distance | 6-minute walk test | complete and recorded data | Posted | Least Squares Mean | Standard Error | percentage of distance walked | 6 months |
|
|
|
| Secondary | Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) | NT-proBNP measured at 6-months compared to baseline | completers | Posted | Least Squares Mean | Standard Error | pg/mL | 6 months |
|
|
|
| 0 |
| 14 |
| 3 |
| 14 |
| 11 |
| 14 |
| EG001 | Placebo | Placebo by mouth twice per day Placebo: Placebo by mouth twice per day for a total of 26 weeks | 1 | 8 | 2 | 8 | 4 | 8 |
| dark urine | Renal and urinary disorders | Non-systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| leg weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| loss of appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| hair loss | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| muscle spasm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| restless sleep | Nervous system disorders | Non-systematic Assessment |
|
| dryness on CPAP | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| TENOSYNOVITIS, | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| fatique | General disorders | Non-systematic Assessment |
|
| bloating | Gastrointestinal disorders | Non-systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |