CompletedNot Applicable

Rhode Island Diastolic Dysfunction - Heart Failure

United States28 participantsStarted 2015-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Change From Baseline in Oxygen Consumption During Maximal Bike Exercise

Timeframe: Baseline (period 0), 3 mos (period 1), 6 mos (period 2)

Trial details

NCT IDNCT02353312

SponsorProvidence VA Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2018-12

Results submitted2024-04-23

View on ClinicalTrials.gov More Heart Failure trials