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Completed

NCT Number: NCT02911337

Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction

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.

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Key information

Conditions

Heart Failure, Diastolic Body Weight Body Weight Changes Cardiovascular Diseases Heart Diseases Heart Failure Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MUSC Gazes Research Institue

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lifestyle modification

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.

Primary outcomes

  1. Change in 6 minute hall walk test from baseline

    Time frame: 6 months

    Exercise capacity

  2. Change in symptoms measured with the Minnesota Living With Heart Failure(MLWHF) scores

    Time frame: 6 months

    Quality of life assessment specific for congestive heart failure

Secondary outcomes

  1. Left Ventricular mass

    Time frame: 6 months

    Changes in left ventricular mass will be measured by transthoracic echocardiography

  2. Brain Natriuretic Peptide

    Time frame: 6 months

    Brain natriuretic peptide will be measured in serum using standard commercial assay

Other outcomes

  1. Left Atrial Volume

    Time frame: 6 months

    Left atrial volume will be measured by transthoracic echocardiography

  2. Early mitral inflow velocity/mitral annular velocity (E/e')

    Time frame: 6 months

    E/e' will be measured by transthoracic echocardiography

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Acronym: WTLSSCHF

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 22, 2016
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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