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Angiotensin Receptor Blocker

Valsartan for Pulmonary Hypertension (REVAMP-PH Trial)

Phase 2
Recruiting
Led By Peter Leary, MD, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to walk with/without a walking aid for a distance of at least 50 meters
NYHA Functional Class II, III, or IV at screening
Must not have
Left sided myocardial disease as evidenced by left ventricular ejection fraction < 40%
ACE-inhibitor, ARB or ARNI use within 30 days of randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 24 weeks

Summary

This trial studies the safety and effectiveness of a drug to treat pulmonary arterial hypertension in adults.

Who is the study for?
Adults aged 18-80 with WHO Group 1 Pulmonary Arterial Hypertension, able to walk at least 50 meters, and have specific heart catheterization results. Excluded are those with very low blood pressure or kidney function issues, expected short survival due to other diseases, certain lung conditions, recent investigational drug use, left heart disease, pregnancy/lactation, non-group 1 pulmonary hypertension or allergy to similar medications.
What is being tested?
The trial is testing the safety and effectiveness of Valsartan (40 mg), an angiotensin receptor blocker for treating pulmonary arterial hypertension over a course of 24 weeks. Participants will be randomly assigned to receive either Valsartan or a placebo in this Phase 2 study.
What are the potential side effects?
Possible side effects of Valsartan may include dizziness due to low blood pressure, increased potassium levels which can affect heart rhythm, kidney function changes and allergic reactions like swelling of the face or difficulty breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk at least 50 meters, with or without help.
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My heart condition limits my physical activity.
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I have been diagnosed with a specific type of high blood pressure in the lungs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's left side is weak, with an ejection fraction below 40%.
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I have taken ACE inhibitors, ARBs, or ARNIs in the last 30 days.
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I do not have severe lung blood pressure issues or specific vein blockages in my lungs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Six-minute walk distance
Secondary study objectives
Change in BNP
Change in New York Heart Association (NYHA) functional class
Change in health related quality of life (emPHasis-10 questionnaire)
+3 more
Other study objectives
Change in Cardiopulmonary Exercise Testing (sub-study): Maximal oxygen uptake
Change in Cardiopulmonary Exercise Testing (sub-study): Total wattage
Change in Cardiopulmonary Exercise Testing (sub-study): Ve/VCO2 slope
+4 more

Side effects data

From 2008 Phase 2 & 3 trial • 1474 Patients • NCT00425373
14%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Valsartan 40 mg
Valsartan 80 mg
Amlodipine 2.5 mg
Valsartan + Amlodipine 40/2.5 mg
Valsartan + Amlodipine 80/2.5 mg
Amlodipine 5 mg
Valsartan + Amlodipine 40/5 mg
Valsartan + Amlodipine 80/5 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ValsartanExperimental Treatment1 Intervention
Valsartan 40mg capsule taken twice daily for 24 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsule taken twice daily for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valsartan 40 mg
2008
Completed Phase 3
~2440

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,883 Total Patients Enrolled
27 Trials studying Pulmonary Arterial Hypertension
3,171 Patients Enrolled for Pulmonary Arterial Hypertension
University of WashingtonLead Sponsor
1,829 Previous Clinical Trials
1,907,034 Total Patients Enrolled
1 Trials studying Pulmonary Arterial Hypertension
80 Patients Enrolled for Pulmonary Arterial Hypertension
Peter Leary, MD, PhDPrincipal InvestigatorUniversity of Washington
~40 spots leftby Jul 2027
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