Heart Failure Clinical Trial

Exercise Intolerance in Elderly Patients With Diastolic Heart Failure

Summary

The purpose of this study is to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with heart failure and a normal ejection fraction (HFNEF) and body mass index greater than or equal to 30.

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Full Description

Heart failure with a normal ejection fraction (HFNEF, previously termed diastolic heart failure), accounts for the majority of heart failure cases in the population > 65 years old and has been recognized as a true geriatric syndrome. Exercise intolerance is the primary chronic symptom of HFNEF and a major determinant of these patients' severely reduced quality of life; however little is known regarding its pathophysiology and treatment. Therefore, our work has focused on understanding the pathophysiology of exercise intolerance in HFNEF and developing and testing interventions that may improve this pivotal outcome in this highly prevalent disorder of older persons. The aims of the proposed study are to conduct a randomized, controlled, single-blinded, 2x2 design trial to examine the effects of weight loss via hypocaloric diet, aerobic exercise training, combined hypocaloric diet and exercise training, and attention control in patients with HFNEF and body mass index >30 in order to test the following hypotheses: 1) Both weight loss and exercise training will improve exercise intolerance and quality of life in older, obese patients with HFNEF; 2) The combination of weight loss and exercise training will produce complementary effects on body and thigh muscle composition and additive improvements in exercise intolerance in HFNEF; 3) Improvements in exercise intolerance will correlate with improvements in lean body mass, reversal of adverse thigh muscle remodeling, and increased thigh muscle capillarity. The study has the potential to significantly advance our understanding of exercise intolerance and its treatment in the large population of older persons with HFNEF.

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Eligibility Criteria

Inclusion Criteria:

Heart failure clinical score greater than or equal to 3
Age 60 and over
Normal ejection fraction greater than or equal to 50%
BMI greater than or equal to 30

Exclusion Criteria:

Valvular heart disease
Significant change in cardiac medication <4 weeks
Uncontrolled hypertension
Recent or debilitating stroke
Cancer or other noncardiovascular conditions with life expectancy less than 2 years
Significant Anemia
Renal insufficiency (creatinine >2.5mg/dl)
Psychiatric disease- uncontrolled major psychoses, depressions, dementia, or personality disorder
Plans to leave area within 6 months
Refuses informed consent
Failure to pass screening test:pulmonary function, echocardiogram,or exercise

Study is for people with:

Heart Failure

Estimated Enrollment:

100

Study ID:

NCT00959660

Recruitment Status:

Completed

Sponsor:

Wake Forest University

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There is 1 Location for this study

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Wake Forest University Health Sciences
Winston-Salem North Carolina, 27175, United States

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Study is for people with:

Heart Failure

Estimated Enrollment:

100

Study ID:

NCT00959660

Recruitment Status:

Completed

Sponsor:


Wake Forest University

How clear is this clinincal trial information?

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