Exercise Intolerance in Elderly Patients With Diastolic Heart Failure
This trial is active, not recruiting.
|Conditions||heart failure, diastolic, obesity|
|Treatments||exercise, dietary intervention, diet and exercise, attention control|
|Sponsor||Wake Forest University|
|Collaborator||National Institute on Aging (NIA)|
|Start date||February 2009|
|End date||December 2015|
|Trial size||100 participants|
|Trial identifier||NCT00959660, IRB00005668, R37AG018915|
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.
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
|Masking||single blind (outcomes assessor)|
time frame: 20 weeks
Body and thigh muscle composition, Quality of Life
time frame: 20 weeks
Male or female participants at least 60 years old.
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
|Official title||Study of the Effect of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction.(SECRET)|
|Principal investigator||Dalane W Kitzman, MD|
|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.|
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