Reduced Contractile Reserve: a Therapeutic Target in Heart Failure With Preserved Ejection Fraction(HFpEF)

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Amlodipine; Dobutamine

Criteria

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 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.

• No history of heart failure.

• No history of cardiovascular disease, with the exception of hypertension or hyperlipidemia

• History and physical examination free of signs and symptoms of heart failure, including elevated jugular venous pressure, hepatojugular reflux, rales or edema.

• Baseline echocardiographic examination without evidence of heart failure, including systolic dysfunction of the LV or RV, or evidence of more than mild diastolic dysfunction on non-invasive assessment.

HTN/LVH Group

• Known history of hypertension.

• Echocardiographic evidence of left ventricular hypertrophy and diastolic dysfunction.

• No history or physical examination evidence of heart failure, including excessive dyspnea on exertion, dyspnea at rest, orthopnea, PND, jugular venous distention, hepatojugular reflux, rales or edema.