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| ID | Type | Description | Link |
|---|---|---|---|
| R61HL167848 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is a Phase 2, single-center, randomized placebo controlled trial of valsartan (an angiotensin receptor blocker) in adults with pulmonary arterial hypertension. The study will evaluate the safety and clinical efficacy of a 24-week course of valsartan.
Pulmonary arterial hypertension (PAH) is one of many conditions that put stress and strain on the right side of the heart. This stress and strain can cause right heart failure. Although there are medications to treat PAH, there are currently no medications that act directly on the heart to improve right heart function. This is different than left heart failure where one of the cornerstones of treatment is medication targeted at the heart to improve left heart function.
Valsartan is a well-tolerated and inexpensive medication that is currently used to treat hypertension and left heart failure. Preliminary results suggest that valsartan may help the right heart to adapt and strengthen when stressed instead of fail; however, these results are suggestive and not definitive. A randomized controlled trial is required to evaluate the possibility that valsartan can impact right heart function.
Participants in the study will take valsartan or placebo for 24 weeks. They will have three study visits at 0, 2, 12, and 24 weeks. These visits will add 20-30 minutes to the standard clinic visits at those time points and there will be an echocardiogram at weeks 0 and 24. The visits at weeks 2 and 12 may be completed remotely for most participants. Some participants may elect to participate in exercise testing and/or right heart catheterization at weeks 0 and 24; however, this is not required to participate in the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valsartan | Experimental | Valsartan 40mg capsule taken twice daily for 24 weeks. |
|
| Placebo | Placebo Comparator | Placebo capsule taken twice daily for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valsartan 40 mg | Drug | Valsartan 40mg twice daily for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute walk distance | To determine whether valsartan increases six-minute walk distance at 24 weeks in men and women with pulmonary arterial hypertension. | 0 to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BNP | To determine whether valsartan reduces BNP at 24 weeks | 0 to 24 weeks |
| Change in New York Heart Association (NYHA) functional class | To determine whether valsartan improves New York Heart Association (NYHA) functional class at 24 weeks (NYHA Functional Class is a score from 1 to 4 where higher scores connote worse health-related impairment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in invasive hemodynamics (sub-study): Stroke Volume Index | To determine whether valsartan increases stroke volume index at 24 weeks | 0 to 24 weeks |
| Change in invasive hemodynamics (sub-study): Wedge pressure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurie Hogl, RRT | Contact | 206.543.8334 | lalnaser@uw.edu | |
| Nancy Liston, MS | Contact | 206.543.8334 | nmliston@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Peter Leary, MD, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Medical Center | Recruiting | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33031831 | Background | Lahm T, Hess E, Baron AE, Maddox TM, Plomondon ME, Choudhary G, Maron BA, Zamanian RT, Leary PJ. Renin-Angiotensin-Aldosterone System Inhibitor Use and Mortality in Pulmonary Hypertension: Insights From the Veterans Affairs Clinical Assessment Reporting and Tracking Database. Chest. 2021 Apr;159(4):1586-1597. doi: 10.1016/j.chest.2020.09.258. Epub 2020 Oct 5. |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D006333 | Heart Failure |
| D018497 | Ventricular Dysfunction, Right |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo twice daily for 24 weeks. |
|
| 0 to 24 weeks |
| Change in right ventricular morphology by echocardiogram (right ventricular dilation) | To determine whether valsartan improves right ventricular morphology at 24 weeks including improved right ventricular dilation | 0 to 24 weeks |
| Change in right ventricular morphology by echocardiogram (tricuspid annular plane systolic excursion(TAPSE)) | To determine whether valsartan improves right ventricular morphology at 24 weeks including improved TAPSE | 0 to 24 weeks |
| Change in health related quality of life (emPHasis-10 questionnaire) | To determine whether valsartan improves health related quality of life as estimated by the emPHasis- 10 score (Each item on the emPHasis-10 questionnaire is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end; EmPHasis-10 scores range from 0 to 50 with higher scores indicating worse quality of life) | 0 to 24 weeks |
| Frequency of escalation for PAH focused care (increased diuretics, escalating doses of pulmonary vasodilators, and/or adding additional pulmonary vasodilators) | To determine whether valsartan decreases the need to escalate PAH focused care (increased diuretics, escalating doses of pulmonary vasodilators, and/or adding an additional pulmonary vasodilator) | 0 to 24 weeks |
Exploratory: To explore whether valsartan is associated with differences in wedge pressure at 24 weeks
| 0 to 24 weeks |
| Change in invasive hemodynamics (sub-study): Right Atrial pressure | Exploratory: To explore whether valsartan is associated with differences in right atrial pressure at 24 weeks | 0 to 24 weeks |
| Change in invasive hemodynamics (sub-study): Pulmonary Vascular Resistance | Exploratory: To explore whether valsartan is associated with differences in pulmonary vascular resistance at 24 weeks | 0 to 24 weeks |
| Change in Cardiopulmonary Exercise Testing (sub-study): Maximal oxygen uptake | To determine whether valsartan increases maximal oxygen uptake in individuals with pulmonary arterial hypertension at 24 weeks | 0 to 24 weeks |
| Change in Cardiopulmonary Exercise Testing (sub-study): Ve/VCO2 slope | Exploratory: To explore whether valsartan decreases the Ve/VCO2 slope in individuals with pulmonary arterial hypertension over 24 weeks | 0 to 24 weeks |
| Change in Cardiopulmonary Exercise Testing (sub-study): Total wattage | Exploratory: To explore whether valsartan increases total achieved wattage in individuals with pulmonary arterial hypertension over 24 weeks | 0 to 24 weeks |
| D002318 |
| Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |