Exercise Intolerance in Elderly Patients With Diastolic Heart Failure

Obesity Clinical Trial

— SECRET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959660
• Other study ID #: IRB00005668
• Secondary ID: R37AG018915
• Status: Completed
• Phase: N/A
• Start date: February 2009
• Est. completion date: August 2013

Study information

• Verified date: February 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2013
• Est. primary completion date: August 15, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic
• Obesity

Intervention

Behavioral:
• Exercise
walking, treadmill and bicycle exercise

Dietary Supplement:
• Dietary Intervention
Subjects will be provided meals and instructions for individual food selections.

Behavioral:
• Diet and exercise
Subjects will be provided meals and instructions for individual food selections and will undergo walking, treadmill and bicycle exercise.

Other:
• Attention Control
control group- continue their previously randomized life style

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Capacity	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.	20 weeks
Secondary	Quality of Life	Heart failure-specific quality of life was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) on a range 0-100; higher scores indicate better quality of life.	20 weeks
Secondary	Body Composition	Total Body Fat Mass and Total Non-bone Lean Mass via DEXA	20 weeks
Secondary	Thigh Muscle Composition	Thigh Skeletal Muscle and Subcutaneous Fat via MRI	20 weeks