Pulmonary Arterial Hypertension study: Valsartan
Official title Repurposing Valsartan May Protect Against Pulmonary Hypertension
ClinicalTrials.gov ID: NCT06053580
What this study is testing
What is Valsartan 40 mg?
This is an investigational medicine being studied to see if it helps with pulmonary arterial hypertension. It is designed to block a hormone called angiotensin that can make blood vessels tighten and raise blood pressure.
Also referred to as Diovan.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe valsartan is and whether it improves symptoms and heart function in people with pulmonary arterial hypertension.
- Who it's for
- Adults who have been diagnosed with pulmonary arterial hypertension.
- What's involved
- Participants will receive either valsartan or a placebo for 24 weeks, with regular visits and tests to monitor safety and effectiveness.
- Time commitment
- The study lasts 24 weeks and includes scheduled visits throughout that period.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Participants with a right heart catheterization within five years demonstrating a mean pulmonary arterial pressure of ≥ 25 mmHg and occlusion...
You likely can't join if
- 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...
- 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%
See the full eligibility criteria
- 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...
- Able to walk with/without a walking aid for a distance of at least 50 meters
- 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%
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.