Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction

NCT ID: NCT02911337

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-12-28

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.

Conditions

Heart Failure, Diastolic; Weight Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle modification

Lifestyle modification

Group Type: EXPERIMENTAL

lifestyle modification

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

lifestyle modification

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MUSC Gazes Research Institue

Charleston, South Carolina, United States

Countries

United States

References

El Hajj EC, El Hajj MC, Sykes B, Lamicq M, Zile MR, Malcolm R, O'Neil PM, Litwin SE. Pragmatic Weight Management Program for Patients With Obesity and Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2021 Nov 2;10(21):e022930. doi: 10.1161/JAHA.121.022930. Epub 2021 Oct 29.

Reference Type: DERIVED

PMID: 34713711 (View on PubMed)

Other Identifiers

WTLSSCHF

Identifier Type: -

Identifier Source: org_study_id