Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction
Completed · Not applicable
Conditions studied: Heart Failure, Diastolic, Weight Loss
In brief
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.
Key facts
- Study ID
- NCT02911337
- Run by
- Medical University of South Carolina
- People needed
- 60
- Starts
- 2015-08-01
- Expected to finish
- 2018-12-28
- Last updated by the study team
- 2025-07-10
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
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
- 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
Where it is running
- MUSC Gazes Research Institue — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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