Pulmonary Arterial HypertensionPhase 2REVAMP-PHNCT06053580
Repurposing Valsartan May Protect Against Pulmonary Hypertension
A Phase 2 study testing Valsartan 40 mg in people with Pulmonary Arterial Hypertension and Right Heart Failure, run by University of Washington at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Right Heart Failure, Right Ventricular Dysfunction
- What is being tested?
- Valsartan 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2024to 1 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 to 80
- WHO Group 1 Pulmonary Arterial Hypertension
- NYHA Functional Class II, III, or IV at screening (Appendix 2 for Functional Class Decision Aid)
- Right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of ≥25 mmHg, occlusion pressure of ≤15 mmHg, and resistance ≥ 3 wood units
- Participants with a right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of ≥ 25 mmHg and occlusion pressure of 15 - 20 mmHg will be considered for inclusion if the pulmonary vascular resistance ≥ 9 wood units and they are being treated with pulmonary arterial hypertension specific therapy
- Able to walk with/without a walking aid for a distance of at least 50 meters
Who cannot join
- Pregnant or lactating
- Non-group 1 pulmonary hypertension or veno-occlusive disease
- History of interstitial lung disease, unless subject has collagen vascular disease and has pulmonary function testing conducted within 12 months demonstrating a total lung capacity or vital capacity of ≥ 60 %
- Has received or will receive an investigational drug, device, or study within 30 days or during the course of study
- ACE-inhibitor, ARB or ARNI use within 30 days of randomization.
- Left sided myocardial disease as evidenced by left ventricular ejection fraction < 40%
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- Any other clinically significant illness or abnormal laboratory values (measured during the Screening period) that, in the opinion of the Investigator, might put the subject at risk of harm during the study or might adversely affect the interpretation of the study data
- Anticipated survival less than 1 year due to concomitant disease
- Allergy or angioedema with ACE-inhibitor use
- Potassium >5mEq/L or sCr >2mg/dL at screening
- SBP <90mmHg at screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Washington Medical Center
Seattle, Washington, 98195
Laurie Hogl, 2065438334, lalnaser@uw.edu
Peter J Leary, MD, PhD
About this study
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.
Read the detailed description
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.
- Conditions
- Pulmonary Arterial Hypertension, Right Heart Failure, Right Ventricular Dysfunction, Pulmonary Vascular Disorder
- Being tested
- Valsartan 40 mg, Placebo
- Medical subject headings
- Pulmonary Arterial Hypertension, Heart Failure, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan 40 mgDrug
Also called Diovan
Valsartan 40mg twice daily for 24 weeks.
PlaceboDrug
Placebo twice daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Valsartan | Experimental | Valsartan 40mg capsule taken twice daily for 24 weeks. Receives: Drug: Valsartan 40 mg |
| Placebo | Placebo comparator | Placebo capsule taken twice daily for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk distance
To determine whether valsartan increases six-minute walk distance at 24 weeks in men and women with pulmonary arterial hypertension.
Measured: 0 to 24 weeks
Secondary outcomes (6)
Change in BNP
To determine whether valsartan reduces BNP at 24 weeks
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 0 to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start28 Feb 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Peter Leary, University of Washington
- Investigators
- Peter Leary, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053580
- Sponsor's protocol ID
- STUDY00018685
- Other IDs
- R61HL167848
- Acronym
- REVAMP-PH
- Status last verified
- Apr 2026
- First submitted
- 7 Sep 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33031831
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repurposing Valsartan May Protect Against Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT06053580
- Acronym / sponsor ID
- REVAMP-PH / STUDY00018685
- Conditions
- Pulmonary Arterial Hypertension, Right Heart Failure, Right Ventricular Dysfunction, Pulmonary Vascular Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valsartan | Experimental | Drug: Valsartan 40 mgValsartan 40mg capsule taken twice daily for 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule taken twice daily for 24 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, age 18 to 80
- WHO Group 1 Pulmonary Arterial Hypertension
- NYHA Functional Class II, III, or IV at screening (Appendix 2 for Functional Class Decision Aid)
- Right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of ≥25 mmHg, occlusion pressure of ≤15 mmHg, and resistance ≥ 3 wood units
- Participants with a right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of ≥ 25 mmHg and occlusion pressure of 15 - 20 mmHg will be considered for inclusion if the pulmonary vascular resistance ≥ 9 wood units and they are being treated with pulmonary arterial hypertension specific therapy
Key exclusion criteria (11 listed)
- Pregnant or lactating
- Non-group 1 pulmonary hypertension or veno-occlusive disease
- History of interstitial lung disease, unless subject has collagen vascular disease and has pulmonary function testing conducted within 12 months demonstrating a total lung capacity or vital capacity of ≥ 60 %
- Has received or will receive an investigational drug, device, or study within 30 days or during the course of study
- ACE-inhibitor, ARB or ARNI use within 30 days of randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valsartan 40 mgAlso: DiovanValsartan 40mg twice daily for 24 weeks. | Drug | Valsartan |
| PlaceboPlacebo twice daily for 24 weeks. | Drug | Placebo |
Primary outcome
Six-minute walk distance
Time frame: 0 to 24 weeks
To determine whether valsartan increases six-minute walk distance at 24 weeks in men and women with pulmonary arterial hypertension.
6 secondary outcomes
Change in BNP
Time frame: 0 to 24 weeks
Change in New York Heart Association (NYHA) functional class
Time frame: 0 to 24 weeks
Change in right ventricular morphology by echocardiogram (right ventricular dilation)
Time frame: 0 to 24 weeks
Change in right ventricular morphology by echocardiogram (tricuspid annular plane systolic excursion(TAPSE))
Time frame: 0 to 24 weeks
Change in health related quality of life (emPHasis-10 questionnaire)
Time frame: 0 to 24 weeks
Frequency of escalation for PAH focused care (increased diuretics, escalating doses of pulmonary vasodilators, and/or adding additional pulmonary vasodilators)
Time frame: 0 to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 33031831Lahm 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Leary, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valsartan 40 mg in people with Pulmonary Arterial Hypertension and Right Heart Failure, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie Hogl, RRT (206.543.8334, lalnaser@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk distance (time frame: 0 to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06053580, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.