Reduced Contractile Reserve: a Therapeutic Target in Heart Failure With Preserved Ejection Fraction(HFpEF)
Completed · Not applicable · Has a placebo group
Conditions studied: Heart Failure With Preserved Ejection Fraction, Pulmonary Disease, Left Ventricular Hypertrophy/Hypertension
In brief
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.
Key facts
- Study ID
- NCT01354613
- Run by
- University of Wisconsin, Madison
- People needed
- 14
- Starts
- 2011-04-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2019-04-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 manifest by at least 2 symptoms or signs, including dyspnea on exertion or at rest, orthopnea, jugular venous distention or hepatojugular reflux, rales or edema.
- Controlled systolic BP (< 150 mmHg on the day of study)
- Pulmonary Disease Group
- Known obstructive airways disease with objective documentation of an isolated obstructive defect by pulmonary function testing.
Where it is running
- UW - Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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