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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
Results First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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 Phase
Heart Failure, Diastolic Obesity Behavioral: Exercise Dietary Supplement: Dietary Intervention Behavioral: Diet and exercise Other: Attention Control Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : August 15, 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Exercise Training
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.
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
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.
Behavioral: Exercise
walking, treadmill and bicycle exercise

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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

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

Information from the National Library of Medicine

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


Locations
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)
Investigators
Principal Investigator: Dalane W Kitzman, MD Wake Forest University Health Sciences

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
Results First Posted: April 11, 2018
Last Update Posted: April 11, 2018
Last Verified: March 2018

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

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