Study of the Effect of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction.(SECRET)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure, Diastolic
- Sponsor
- Wake Forest University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Exercise Capacity
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Detailed 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.
Investigators
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
Outcomes
Primary Outcomes
Exercise Capacity
Time Frame: 20 weeks
Exercise capacity assessed as Peak VO2 (ml/kg/min) via treadmill cardiopulmonary exercise testing using the modified Naughton protocol to the end point of exhaustion.
Secondary Outcomes
- Quality of Life(20 weeks)
- Body Composition(20 weeks)
- Thigh Muscle Composition(20 weeks)