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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0 to 24 weeks

Awards & highlights

REVAMP-PH Trial 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.Check my eligibility

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.See study design

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.

REVAMP-PH Trial 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.

Select...

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.

REVAMP-PH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 24 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Six-minute walk distance

Secondary outcome measures

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 outcome measures

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

Nasopharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

Valsartan + Amlodipine 80/5 mg

Amlodipine 5 mg

Valsartan + Amlodipine 40/5 mg

Placebo

Valsartan 40 mg

Valsartan 80 mg

Amlodipine 2.5 mg

Valsartan + Amlodipine 40/2.5 mg

Valsartan + Amlodipine 80/2.5 mg

REVAMP-PH 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,852,064 Total Patients Enrolled

25 Trials studying Pulmonary Arterial Hypertension

3,091 Patients Enrolled for Pulmonary Arterial Hypertension

University of WashingtonLead Sponsor

1,741 Previous Clinical Trials

1,847,700 Total Patients Enrolled

1 Trials studying Pulmonary Arterial Hypertension

80 Patients Enrolled for Pulmonary Arterial Hypertension

Peter Leary, MD, PhDPrincipal InvestigatorUniversity of Washington

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participant eligibility age for this trial beyond eighty-five years old?

"The enrolment boundaries for this trial mandate that participants must be above 18 years of age and below 80."

Answered by AI

What qualifications must a potential participant have in order to enroll in this investigation?

"This study is open for enrolment to individuals between 18 and 80 years old living with WHO Group 1 Pulmonary Arterial Hypertension. A total of 60 participants are sought after."

Answered by AI

To what extent does Valsartan pose a risk to patient health?

"There is limited evidence of Valsartan's safety, so it has been evaluated with a score of 2."

Answered by AI

Is there still the capacity to enroll participants into this research project?

"As per the information on clinicaltrials.gov, this medical trial is not accepting applicants at present. Initially posted on January 1st 2024 and last updated September 13th 2023, it no longer requires candidates; though there are multiple other trials with vacancies as of now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Repurposing Valsartan May Protect Against Pulmonary Hypertension

Peter Leary 2024. "Repurposing Valsartan May Protect Against Pulmonary Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06053580.

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