Exercise Intolerance in Elderly Patients With Diastolic Heart Failure



Status:Completed
Conditions:Obesity Weight Loss, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:60 - Any
Updated:2/17/2019
Start Date:February 2009
End Date:August 2013

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Study of the Effect of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction.(SECRET)

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.

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.

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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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