N/A
N=28
Rhode Island Diastolic Dysfunction - Heart Failure
Heart Failure · Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT02353312 ↗Enrolled (actual)
28
Serious AEs
17.9%
Results posted
Jul 2025
Primary outcome: Primary: Change From Baseline in Oxygen Consumption During Maximal Bike Exercise — 14.45; 14.18 mL/kg/min — p=0.823
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Kuvan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Providence VA Medical Center
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Oxygen Consumption During Maximal Bike Exercise |
14.45; 14.18 | 0.823 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02353312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.