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| Name | Class |
|---|---|
| The Cardiovascular Medical Research and Education Fund | OTHER |
| Brigham and Women's Hospital | OTHER |
| University of Maryland | OTHER |
| Yale University |
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This study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension specific therapies but with right ventricular dysfunction (RVEF <45%) would improve their outcome. This study is accompanied by a baseline comparison of the metabolic profiling/microRNA/iPS cells of subjects with and without right ventricular dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranolazine | Active Comparator | Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day |
|
| Placebo | Placebo Comparator | Placebo by mouth twice per day |
|
| Observational | No Intervention | Patients with pulmonary hypertension who have normal RV function (RVEF >=45%) will undergo same procedures in the observational arm but will not receive an intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranolazine | Drug | Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Right Ventricular Ejection Fraction | right ventricular ejection fraction by cardiac MRI | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| 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. |
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IPD available upon request
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranolazine | Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day Ranolazine: Ranolazine at 500mg by mouth twice per day and after two weeks will increase 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. |
| FG002 | Observational | Patients with pulmonary hypertension who have normal RV function (RVEF >=45%) will undergo same procedures in the observational arm but will not receive an intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranolazine | Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day Ranolazine: Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks. |
| BG001 |
| 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 | Changes in Right Ventricular Ejection Fraction | right ventricular ejection fraction by cardiac MRI | Completers | Posted | Least Squares Mean | Standard Error | percentage | 6 months |
|
7 months. 6 months of trial and adverse events are gathered for 30 additional days
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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 | Ranolazine | Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day Ranolazine: Ranolazine at 500mg by mouth twice per day and after two weeks will increase 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 hospitalization | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yuchi Han | University of Pennsylvania | 215-662-2855 | yuchi.han@uphs.upenn.edu |
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| 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 | Dec 16, 2015 | Nov 29, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069458 | Ranolazine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| OTHER |
| Washington University School of Medicine | OTHER |
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|
| Placebo | Drug | Placebo by mouth twice per day for a total of 26 weeks. |
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Placebo |
Placebo by mouth twice per day Placebo: Placebo by mouth twice per day for a total of 26 weeks. |
| BG002 | Observational | Patients with pulmonary hypertension who have normal RV function (RVEF >=45%) will undergo same procedures in the observational arm but will not receive an intervention. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Observational | Patients with pulmonary hypertension who have normal RV function (RVEF >=45%) will undergo same procedures in the observational arm but will not receive an intervention. |
|
|
| 0 |
| 7 |
| 1 |
| 7 |
| 5 |
| 7 |
| EG001 | Placebo | Placebo by mouth twice per day Placebo: Placebo by mouth twice per day for a total of 26 weeks. | 0 | 6 | 1 | 6 | 2 | 6 |
| EG002 | Observational | Patients with pulmonary hypertension who have normal RV function (RVEF >=45%) will undergo same procedures in the observational arm but will not receive an intervention. | 0 | 9 | 0 | 9 | 2 | 6 |
| chest pain | Cardiac disorders | Non-systematic Assessment |
|
| hemoptysis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| hyponatremia | Renal and urinary disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| face edema | General disorders | Non-systematic Assessment |
|
| hair loss | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
|