Reduced Contractile Reserve: a Therapeutic Target in Heart Failure With Preserved Ejection Fracti… (NCT01354613) | Clinical Trial Compass
CompletedNot Applicable
Reduced Contractile Reserve: a Therapeutic Target in Heart Failure With Preserved Ejection Fraction(HFpEF)
United States14 participantsStarted 2011-04
Plain-language summary
Heart failure with preserved ejection fraction (HFpEF) accounts for over 50% of heart failure cases in the United States, affecting a primarily elderly population. No treatment has been shown to affect mortality in HFpEF, which is more than 50% at five years a hospitalization. This project explores the underlying cardiovascular physiology of patients with HFpEF with the goal of identifying new therapeutic targets that would allow improved treatment of this devastating disease.
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 or female; Age 18 or older.
* Left ventricular ejection fraction ≥ 50%.
* Symptomatic heart failure or appropriate comparator group criteria
* Informed consent signed by the subject
Exclusion Criteria:
* Symptoms of active ischemia.
* Moderate or severe mitral or aortic stenosis, or severe aortic insufficiency.
* Serum creatinine \> 3.0 or chronic hemodialysis.
* Known chronic hepatic disease; defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels \> 3.0 times the upper limit of normal as read at the local lab.
* Severe renal dysfunction, i.e. glomerular filtration rate (GFR) \<30 ml/min.
* Atrial fibrillation
* Myocardial infarction within the last year
* Coronary bypass surgery within the last 6 months
* Stroke within the last 6 months
* Known aortic aneurysm
* Contra-indication to withdrawal of beta blocker or antihypertensive medications
* Resting or orthostatic hypotension (SBP \< 90 mmHg)
* Any gastrointestinal disorder which would interfere with drug absorption
* Any significant valvular heart disease, including prior multiple valve replacement.
* Pericardial Disease
* Infiltrative or hypertrophic cardiomyopathy
* Cor pulmonale
* Unstable coronary disease
* Pregnancy
* Any condition which may prevent the subject from adhering to the study protocol, as determined by the investigator
Heart Failure with Preserved Ejection Fraction
* Clinical evidence of heart failure with preserved ejection fraction, as manife…
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 in ejection fraction with 5mcg/kg/min dobutamine