Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction (WTLSSCHF)

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Heart Failure, Diastolic
• Intervention / Treatment: Dietary supplement: lifestyle modification

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC Gazes Research Institue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle modification	Dietary supplement: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left Atrial Volume	Left atrial volume will be measured by transthoracic echocardiography	6 months
Early mitral inflow velocity/mitral annular velocity (E/e')	E/e' will be measured by transthoracic echocardiography	6 months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): December 28, 2018
• Study Completion (Actual): December 28, 2018

Study Registration Dates

• First Submitted: July 23, 2015
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (Estimated): September 22, 2016

Study Record Updates

• Last Update Posted (Actual): July 10, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Body Weight Changes; Heart Failure; Weight Loss; Body Weight; Heart Failure, Diastolic
• Other Study ID Numbers: WTLSSCHF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO