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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Oxygen Consumption During Maximal Bike Exercise
Timeframe: Baseline (period 0), 3 mos (period 1), 6 mos (period 2)