Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction (WTLSSCHF)
Primary Purpose
Heart Failure, Diastolic, Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lifestyle modification
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Diastolic
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:
- 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
Sites / Locations
- MUSC Gazes Research Institue
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lifestyle modification
Arm Description
Lifestyle modification
Outcomes
Primary Outcome Measures
Change in 6 minute hall walk test from baseline
Exercise capacity
Change in symptoms measured with the Minnesota Living With Heart Failure(MLWHF) scores
Quality of life assessment specific for congestive heart failure
Secondary Outcome Measures
Left Ventricular mass
Changes in left ventricular mass will be measured by transthoracic echocardiography
Brain Natriuretic Peptide
Brain natriuretic peptide will be measured in serum using standard commercial assay
Full Information
NCT ID
NCT02911337
First Posted
July 23, 2015
Last Updated
January 2, 2019
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02911337
Brief Title
Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction
Acronym
WTLSSCHF
Official Title
Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 28, 2018 (Actual)
Study Completion Date
December 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diastolic, Weight Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle modification
Arm Type
Experimental
Arm Description
Lifestyle modification
Intervention Type
Dietary Supplement
Intervention Name(s)
lifestyle modification
Intervention Description
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 Outcome Measure Information:
Title
Change in 6 minute hall walk test from baseline
Description
Exercise capacity
Time Frame
6 months
Title
Change in symptoms measured with the Minnesota Living With Heart Failure(MLWHF) scores
Description
Quality of life assessment specific for congestive heart failure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Left Ventricular mass
Description
Changes in left ventricular mass will be measured by transthoracic echocardiography
Time Frame
6 months
Title
Brain Natriuretic Peptide
Description
Brain natriuretic peptide will be measured in serum using standard commercial assay
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Left Atrial Volume
Description
Left atrial volume will be measured by transthoracic echocardiography
Time Frame
6 months
Title
Early mitral inflow velocity/mitral annular velocity (E/e')
Description
E/e' will be measured by transthoracic echocardiography
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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:
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
Facility Information:
Facility Name
MUSC Gazes Research Institue
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34713711
Citation
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.
Results Reference
derived
Learn more about this trial
Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction
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