Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction

Study Overview
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Brief Summary
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The purpose of this study is to examine the efficacy of an intensive, supervised, lifestyle modification program on symptoms and signs of heart failure as well as laboratory and echocardiographic measures of cardiac structure and function. This will be a 6 month trial in 50 patients with a clinical diagnosis of heart failure with preserved ejection fraction (HFpEF). Patients will be enrolled in the Medical University of South Carolina weight management 15 week lifestyle change program which will involve weekly visits that rotate among the clinical specialities (dietary, exercise and behavioral) and scheduled visits with the research Registered Nurse. Each patients baseline data will be used as the control and compared with the same measurements at the 6 month end point.

Official Title
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Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction

Conditions
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Heart Failure, Diastolic, Weight Loss

Intervention / Treatment
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* Dietary Supplement: lifestyle modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 30 Able to perform 6 minute hall walk test Left Ventricular ejection fraction >45% Diagnosis of heart failure with preserved ejection fraction (HFpEF) ; confirmation of HFpEF based on 1 major or 3 minor criteria listed below. Major: Elevated BNP >200 cardiogenic pulmonary edema Pulmonary capillary wedge pressure at rest >15 mmhg or with exercise >25 mmhg using invasive right heart pressure measurement Minor: Left atrial enlargement (volume >68 ml) increased left ventricular wall thickness (>1.1cm) by echocardiography E/e' >15 intermediate level of BNP, 60-199 Exclusion Criteria: uncontrolled blood pressure severe chronic obstructive pulmonary disease (oxygen or steroid dependent) recurrent major depression. presence or history of suicide behavior, and current substantial depressive symptoms. Antidepressant drugs are allowed if the dose has been stable for 3 months other major psychiatric illness (schizophrenia, bipolar, dementia) significant hepatic dysfunction untreated hypothyroidism or hyperthyroidism history of drug or alcohol abuse or dependency within the past 12 months acute coronary syndrome without revascularization in the past 12 months acute coronary syndrome with revascularization in the past 6 months Cerebrovascular accident or transient ischemic attack in the past 6 months cancer or terminal illness with life expectancy < 3 years history of medical noncompliance significant anemia (hgb <9) life threatening or uncontrolled arrhythmia hemodynamically relevant valvular heart disease infiltrative heart disease including cardiac amyloidosis, sarcoidosis, Fabry's disease genetic hypertrophic cardiomyopathy significant pericardial disease clinically relevant neuromuscular disease pregnant or may become pregnant in the next 6 months prior major organ transplant or intent to transplant ( on the transplant list) pacemaker dependant clinically significant congenital heart disease that may be cause of symptoms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle modification<br>Lifestyle modification | Dietary Supplement: lifestyle modification<br>* Subjects will be given meal replacements (shakes and bars) to be consumed twice per day for 8 weeks, and then once per day for an additional 3 weeks, and then transitioned to a structured diet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6 minute hall walk test from baseline | Exercise capacity | 6 months | 
| Change in symptoms measured with the Minnesota Living With Heart Failure(MLWHF) scores | Quality of life assessment specific for congestive heart failure | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular mass | Changes in left ventricular mass will be measured by transthoracic echocardiography | 6 months | 
| Brain Natriuretic Peptide | Brain natriuretic peptide will be measured in serum using standard commercial assay | 6 months |