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Completed

NCT Number: NCT00959660

Exercise Intolerance in Elderly Patients With Diastolic Heart Failure

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 271757, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

walking, treadmill and bicycle exercise

dietary intervention

Dietary Supplement

Subjects will be provided meals and instructions for individual food selections.

Diet and Exercise

Behavioral

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

Attention Control

Other

control group- continue their previously randomized life style

Primary outcomes

  1. 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

  1. Quality of Life

    Time frame: 20 weeks

    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.

  2. Body Composition

    Time frame: 20 weeks

    Total Body Fat Mass and Total Non-bone Lean Mass via DEXA

  3. Thigh Muscle Composition

    Time frame: 20 weeks

    Thigh Skeletal Muscle and Subcutaneous Fat via MRI

Sponsors and collaborators

Lead sponsor

Wake Forest University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: SECRET

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Aug 17, 2009
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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