Weight Loss as Therapy for Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in 6 minute hall walk test from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
- •Left atrial enlargement (volume >68 ml)
- •increased left ventricular wall thickness (>1.1cm) by echocardiography
- •intermediate level of BNP, 60-199
排除标准
- •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
研究组 & 干预措施
Lifestyle modification
Lifestyle modification
干预措施: lifestyle modification (Dietary Supplement)
结局指标
主要结局
Change in 6 minute hall walk test from baseline
时间窗: 6 months
Exercise capacity
Change in symptoms measured with the Minnesota Living With Heart Failure(MLWHF) scores
时间窗: 6 months
Quality of life assessment specific for congestive heart failure
次要结局
- Left Ventricular mass(6 months)
- Brain Natriuretic Peptide(6 months)