Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction

Not Applicable

Completed

• Conditions: Heart Failure, Diastolic; Weight Loss
• Interventions: Dietary Supplement: lifestyle modification

• Registration Number: NCT02911337
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-07-23
• Study Start: 2015-08
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Primary Completion: 2018-12-28
• Study Completion: 2018-12-28
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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:

1. Elevated BNP >200
2. cardiogenic pulmonary edema
3. Pulmonary capillary wedge pressure at rest >15 mmhg or with exercise >25 mmhg using invasive right heart pressure measurement

Minor:

1. Left atrial enlargement (volume >68 ml)
2. increased left ventricular wall thickness (>1.1cm) by echocardiography
3. E/e' >15
4. intermediate level of BNP, 60-199

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle modification	lifestyle modification	Lifestyle modification

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Left Ventricular mass	6 months	Changes in left ventricular mass will be measured by transthoracic echocardiography
Brain Natriuretic Peptide	6 months	Brain natriuretic peptide will be measured in serum using standard commercial assay

Trial Locations

Locations (1)

MUSC Gazes Research Institue; 🇺🇸 Charleston, South Carolina, United States