Rhode Island Diastolic Dysfunction - Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure, Cardiovascular Disease

In brief

To study the hypothesis that treating patients with underlying diastolic dysfunction with oral Kuvan® (BH4, also known as tetrahydrobiopterin) in addition to current best practices will improve metabolic and echocardiographic diastolic function parameters.

Key facts

Study ID

NCT02353312

Run by

Providence VA Medical Center

People needed

28

Starts

2015-03-01

Expected to finish

2018-12-01

Last updated by the study team

2025-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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)
• Presence of hypertrophic cardiomyopathy
• Presence of infiltrative/restrictive cardiomyopathy
• Echocardiographic evidence of moderate or severe aortic or mitral valve stenosis or regurgitation
• Previously diagnosed phenylketonuria
• End stage renal disease requiring hemodialysis
• Pre-existing seizure disorder
• Terminal illness (not including heart failure) with expected survival of one year or less
• Females who are pregnant or breastfeeding. All females of child bearing age will undergo pregnancy testing prior to randomization.
• Recent hospitalization within three months.
• Previous Bioprosthetic and/or mechanical aortic or mitral valves

Where it is running

• Providence VAMC — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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