Completed

RIDD-HFBH4 Treatment for Diastolic Dysfunction in Heart Failure

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Study Aim

This study aims to evaluate the impact of BH4 treatment on diastolic dysfunction in heart failure patients, specifically focusing on changes in oxygen consumption during maximal bike exercise as a measure of cardiovascular health.

What is being tested

Kuvan

Drug
Who is being recruted

Cardiovascular Diseases+3

+ Heart Diseases

+ Heart Failure

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2015
See protocol details

Summary

Principal SponsorProvidence VA Medical Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2015

Actual date on which the first participant was enrolled.

Heart failure is a serious condition affecting millions of people in the United States alone. About half of these individuals have a type of heart failure known as heart failure with preserved ejection fraction (HFpEF), or diastolic heart failure. This condition is characterized by symptoms such as shortness of breath, swelling, fatigue, and reduced exercise tolerance. The causes of diastolic heart failure are not fully understood, making it difficult to treat effectively. Currently, there are no FDA-approved treatments for this condition, and standard heart failure treatments do not work. This study focuses on a potential underlying cause of diastolic heart failure - a decrease in nitric oxide, a substance that helps regulate blood pressure and blood flow. Research suggests that a substance called BH4, which helps produce nitric oxide, might improve diastolic heart failure. However, the effects of BH4 on diastolic heart failure in humans have not been studied yet. In this treatment study, participants will receive BH4 to see if it can improve heart function. The main goal is to measure changes in oxygen consumption during maximum exercise, an indicator of heart and lung health. This will be assessed using a cardiopulmonary exercise test (CPET). The test results will be recorded in milliliters of oxygen per kilogram of body weight per minute (mL/kg/min). An increase in oxygen consumption from the start to the end of the study suggests an improvement in heart and lung health.

Official TitleRhode Island Diastolic Dysfunction - Heart Failure
NCT02353312
Principal SponsorProvidence VA Medical Center
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

28 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart FailureHeart MurmursSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

3 inclusion criteria required to participate
Male and female U.S. Veteran patients over the age of eighteen, with echocardiographic findings of >= Grade 2 diastolic dysfunction [as per American Society of Echocardiography guidelines] and

Diagnosis of hypertension, diabetes, or heart failure in medical records.

Eligible subjects must be ambulatory (not dependent on any ambulatory assist devices including cane or walker).

13 exclusion criteria prevent from participating
Previous Bioprosthetic and/or mechanical aortic or mitral valves

Any history of documented ejection fraction <50%

Significant COPD (defined as oxygen-dependent COPD)

Acute coronary syndrome within the past three months defined by EKG changes and biomarkers of myocardial necrosis (ie. elevated troponin) in the setting of chest pain or an anginal equivalent)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Standard care for heart failure for three months. At the end of three months, Starting Kuvan® supplementation in addition to Standard care for heart failure for another 3 months

Group II

Experimental
Kuvan® supplementation in addition to standard care for heart failure for three months. At the end of three months, stop Kuvan®, patients will only receive Standard care for heart failure for another 3 months

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Providence VAMC

Providence, United StatesOpen Providence VAMC in Google Maps
CompletedOne Study Center