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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dalane W. Kitzman, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00959660
First received: August 14, 2009
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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 Intervention
Heart Failure, Diastolic
Obesity
Behavioral: Exercise
Dietary Supplement: Dietary Intervention
Behavioral: Diet and exercise
Other: Attention Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Exercise capacity [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body and thigh muscle composition, Quality of Life [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise Training
Based on initial evaluations and the stress testing results, (HR, VO2, RPE) 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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959660

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston Salem, North Carolina, United States, 271757
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Dalane W Kitzman, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Dalane W. Kitzman, Professor Internal Medicine Cardiology/Gerontology, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT00959660     History of Changes
Other Study ID Numbers: IRB00005668, R37AG018915
Study First Received: August 14, 2009
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Diastolic heart failure
Heart Failure
Elderly
Obesity

Additional relevant MeSH terms:
Heart Failure
Obesity
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014