Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 1/5/2019 |
| Start Date: | August 2015 |
| End Date: | December 28, 2018 |
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.
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.
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
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