NCT02911337

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2018

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

3.4 years

First QC Date

July 23, 2015

Last Update Submit

July 7, 2025

Conditions

Heart Failure, DiastolicWeight Loss

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Left Ventricular mass

    6 months

  • Brain Natriuretic Peptide

    6 months

Other Outcomes (2)

  • Left Atrial Volume

    6 months

  • Early mitral inflow velocity/mitral annular velocity (E/e')

    6 months

Study Arms (1)

Lifestyle modification

EXPERIMENTAL

Lifestyle modification

Dietary Supplement: lifestyle modification

Interventions

lifestyle modificationDIETARY_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.

Lifestyle modification

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUSC Gazes Research Institue

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • 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.

    PMID: 34713711DERIVED

MeSH Terms

Conditions

Heart Failure, DiastolicWeight Loss

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2015

First Posted

September 22, 2016

Study Start

August 1, 2015

Primary Completion

December 28, 2018

Study Completion

December 28, 2018

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)