Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction

Weight Loss Clinical Trial

— WTLSSCHF  

Official title:

Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911337
• Other study ID #: WTLSSCHF
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 28, 2018

Study information

• Verified date: January 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 28, 2018
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Heart Failure
• Heart Failure, Diastolic
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	MUSC Gazes Research Institue	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Left Atrial Volume	Left atrial volume will be measured by transthoracic echocardiography	6 months
Other	Early mitral inflow velocity/mitral annular velocity (E/e')	E/e' will be measured by transthoracic echocardiography	6 months
Primary	Change in 6 minute hall walk test from baseline	Exercise capacity	6 months
Primary	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	Left Ventricular mass	Changes in left ventricular mass will be measured by transthoracic echocardiography	6 months
Secondary	Brain Natriuretic Peptide	Brain natriuretic peptide will be measured in serum using standard commercial assay	6 months