Overview

This trial is active, not recruiting.

Conditions heart failure, diastolic, obesity
Treatments exercise, dietary intervention, diet and exercise, attention control
Sponsor Wake Forest University
Collaborator National Institute on Aging (NIA)
Start date February 2009
End date December 2015
Trial size 100 participants
Trial identifier NCT00959660, IRB00005668, R37AG018915

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Based on initial evaluations and the stress testing results, (HR, VO2, RPE) an individualized exercise prescription will be developed for each subject.
exercise
walking, treadmill and bicycle exercise
(Active Comparator)
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.
dietary intervention
Subjects will be provided meals and instructions for individual food selections.
(Active Comparator)
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.
attention control
control group- continue their previously randomized life style
(Active Comparator)
The diet and exercise group is a combination of the two groups previously described.
exercise
walking, treadmill and bicycle exercise
diet and exercise
Combination of the exercise and diet group as previously described.

Primary Outcomes

Measure
Exercise capacity
time frame: 20 weeks

Secondary Outcomes

Measure
Body and thigh muscle composition, Quality of Life
time frame: 20 weeks

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Study of the Effect of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction.(SECRET)
Principal investigator Dalane W Kitzman, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.