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

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ClinicalTrials.gov Identifier: NCT00959660
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : January 5, 2018
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Heart Failure, Diastolic Obesity Behavioral: Exercise Dietary Supplement: Dietary Intervention Behavioral: Diet and exercise Other: Attention Control

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Effect of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction.(SECRET)
Actual Study Start Date : February 2009
Primary Completion Date : August 15, 2012
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Exercise Training
Based on initial evaluations and the stress testing results, (HR(heart rate), VO2(maximal volume of oxygen that the body can deliver to the working muscles per minute), RPE(rate perceived exertion) an individualized exercise prescription will be developed for each subject.
Behavioral: Exercise
walking, treadmill and bicycle exercise
Active Comparator: Dietary Intervention
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 Supplement: Dietary Intervention
Subjects will be provided meals and instructions for individual food selections.
Active Comparator: Attention control
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.
Other: Attention Control
control group- continue their previously randomized life style
Active Comparator: Diet and Exercise
The diet and exercise group is a combination of the two groups previously described.
Behavioral: Exercise
walking, treadmill and bicycle exercise
Behavioral: Diet and exercise
Combination of the exercise and diet group as previously described.

Outcome Measures

Primary Outcome Measures :
  1. Exercise capacity [ Time Frame: 20 weeks ]

Secondary Outcome Measures :
  1. Body and thigh muscle composition, Quality of Life [ Time Frame: 20 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959660

United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 271757
Sponsors and Collaborators
Wake Forest University
National Institute on Aging (NIA)
Principal Investigator: Dalane W Kitzman, MD Wake Forest University Health Sciences
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT00959660     History of Changes
Other Study ID Numbers: IRB00005668
R37AG018915 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2017

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Diastolic heart failure
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases