Heart Failure, Diastolic, Obesity
Conditions
Keywords
Diastolic heart failure, Heart Failure, Elderly, Obesity
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.
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.
Interventions
BEHAVIORALExercise
walking, treadmill and bicycle exercise
DIETARY_SUPPLEMENTDietary Intervention
Subjects will be provided meals and instructions for individual food selections.
BEHAVIORALDiet and exercise
Subjects will be provided meals and instructions for individual food selections and will undergo walking, treadmill and bicycle exercise.
OTHERAttention Control
control group- continue their previously randomized life style
Sponsors
National Institute on Aging (NIA)
Wake Forest University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Capacity | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | 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. |
| Body Composition | 20 weeks | Total Body Fat Mass and Total Non-bone Lean Mass via DEXA |
| Thigh Muscle Composition | 20 weeks | Thigh Skeletal Muscle and Subcutaneous Fat via MRI |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Exercise: walking, treadmill and bicycle exercise | 26 |
| 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 Intervention: Subjects will be provided meals and instructions for individual food selections. | 24 |
| 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.
Attention Control: control group- continue their previously randomized life style | 25 |
| Diet and Exercise The diet and exercise group is a combination of the two groups previously described.
Exercise: walking, treadmill and bicycle exercise
Diet and exercise: Combination of the exercise and diet group as previously described. | 25 |
| Total | 100 |
Baseline characteristics
| Characteristic | Exercise Training | Total | Diet and Exercise | Attention Control | Dietary Intervention |
|---|---|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 5.9 | 66.5 years STANDARD_DEVIATION 5.2 | 66.3 years STANDARD_DEVIATION 5.2 | 65.6 years STANDARD_DEVIATION 4.8 | 66.5 years STANDARD_DEVIATION 4.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 45 Participants | 12 Participants | 9 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 55 Participants | 13 Participants | 16 Participants | 11 Participants |
| Sex: Female, Male Female | 21 Participants | 81 Participants | 20 Participants | 20 Participants | 20 Participants |
| Sex: Female, Male Male | 5 Participants | 19 Participants | 5 Participants | 5 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 26 | 1 / 24 | 0 / 25 | 2 / 25 |
| serious Total, serious adverse events | 1 / 26 | 0 / 24 | 1 / 25 | 1 / 25 |
Outcome results
Primary
Exercise Capacity
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.
Time frame: 20 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise Training | Exercise Capacity | 15.5 ml/kg/min |
| Dietary Intervention | Exercise Capacity | 15.5 ml/kg/min |
| Attention Control | Exercise Capacity | 14.1 ml/kg/min |
| Diet and Exercise | Exercise Capacity | 16.6 ml/kg/min |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Secondary
Body Composition
Total Body Fat Mass and Total Non-bone Lean Mass via DEXA
Time frame: 20 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise Training | Body Composition | Total Fat | 45 kg |
| Exercise Training | Body Composition | Total Non-Bone Lean | 52 kg |
| Dietary Intervention | Body Composition | Total Non-Bone Lean | 50 kg |
| Dietary Intervention | Body Composition | Total Fat | 42 kg |
| Attention Control | Body Composition | Total Non-Bone Lean | 53 kg |
| Attention Control | Body Composition | Total Fat | 47 kg |
| Diet and Exercise | Body Composition | Total Fat | 40 kg |
| Diet and Exercise | Body Composition | Total Non-Bone Lean | 50 kg |
Comparison: Total Body Fat Massp-value: <0.001ANCOVA
Comparison: Total Body Fat Massp-value: 0.001ANCOVA
Comparison: Total Non-Bone Lean Massp-value: <0.001ANCOVA
Comparison: Total Non-Bone Lean Massp-value: 0.25ANCOVA
Secondary
Quality of Life
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.
Time frame: 20 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise Training | Quality of Life | 71 units on a scale |
| Dietary Intervention | Quality of Life | 77 units on a scale |
| Attention Control | Quality of Life | 69 units on a scale |
| Diet and Exercise | Quality of Life | 79 units on a scale |
p-value: 0.004ANCOVA
p-value: 0.43ANCOVA
Secondary
Thigh Muscle Composition
Thigh Skeletal Muscle and Subcutaneous Fat via MRI
Time frame: 20 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise Training | Thigh Muscle Composition | Thigh Subcutaneous Fat | 155 cm^2 |
| Exercise Training | Thigh Muscle Composition | Thigh Skeletal Muscle | 120 cm^2 |
| Dietary Intervention | Thigh Muscle Composition | Thigh Skeletal Muscle | 115 cm^2 |
| Dietary Intervention | Thigh Muscle Composition | Thigh Subcutaneous Fat | 143 cm^2 |
| Attention Control | Thigh Muscle Composition | Thigh Subcutaneous Fat | 164 cm^2 |
| Attention Control | Thigh Muscle Composition | Thigh Skeletal Muscle | 121 cm^2 |
| Diet and Exercise | Thigh Muscle Composition | Thigh Subcutaneous Fat | 144 cm^2 |
| Diet and Exercise | Thigh Muscle Composition | Thigh Skeletal Muscle | 114 cm^2 |
Comparison: Thigh Subcutaneous Fatp-value: <0.001ANCOVA
Comparison: Thigh Subcutaneous Fatp-value: 0.26ANCOVA
Comparison: Thigh Skeletal Musclep-value: <0.001ANCOVA
Comparison: Thigh Skeletal Musclep-value: 0.26ANCOVA