Heart Failure Clinical Trial

Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction

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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

60

Study ID:

NCT02911337

Recruitment Status:

Completed

Sponsor:

Medical University of South Carolina

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There is 1 Location for this study

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

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

60

Study ID:

NCT02911337

Recruitment Status:

Completed

Sponsor:


Medical University of South Carolina

How clear is this clinincal trial information?

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