Exercise Intolerance in Elderly Patients With Diastolic Heart Failure (SECRET)

Wake Forest University (WFU)

Status: Completed

Conditions: Heart Failure, Diastolic; Obesity

Treatments: Behavioral: Exercise; Dietary Supplement: Dietary Intervention; Behavioral: Diet and exercise; Other: Attention Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00959660

IRB00005668

R37AG018915 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

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.

Enrollment: 100 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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100 participants in 4 patient groups

Exercise Training

Active Comparator group

Description:

Exercise participants will undergo a 1-hour supervised exercise program 3 times per week for 20 weeks consisting primarily of walking exercise using an individualized exercise prescription based on the initial exercise stress testing results.

Treatment:

Behavioral: Exercise

Dietary Intervention

Active Comparator group

Description:

A hypocaloric diet will be developed to achieve a 2800 kcal/week deficit, which should produce about 0.4 kg (1 lb) weight loss per week.

Treatment:

Dietary Supplement: Dietary Intervention

Attention control

Active Comparator group

Description:

Attention control participants will be provided a counseling session regarding general health education at baseline and will be contacted by staff via telephone every 2 weeks to discuss general health status.

Treatment:

Other: Attention Control

Diet and Exercise

Active Comparator group

Description:

A hypocaloric diet will be developed to achieve a 2450 kcal/week deficit in addition to undergoing a 1-hour supervised exercise program 3 times per week for 20 weeks consisting primarily of walking exercise using an individualized exercise prescription based on the initial exercise stress testing results.

Treatment:

Behavioral: Exercise

Behavioral: Diet and exercise