Status:
COMPLETED
The Effect of Diet and Exercise in Heart Failure
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Heart Failure, Congestive
Metabolic Syndrome X
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
A growing number of people in this country are overweight or obese. This is concerning as increasing weight has been shown to increase the risk of developing heart failure. However, there is also rese...
Eligibility Criteria
Inclusion
- Must meet 3 or more of the NCEP defined criteria for metabolic syndrome
- Waist circumference greater than 40 inches (102 cm) for men and 35 inches ( 88 cm) for women
- Serum triglyceride level greater than or equal to 150 mg/dL
- HDL level less than 40 mg/dL for men or 50 mg/dL for women
- Blood pressure greater than 130/85 or treatment for hypertension
- Fasting glucose greater than 110 mg/dL or treatment for diabetes
- Individuals with heart failure of ischemic or nonischemic etiologies \* NYHA class II - III symptoms
- Left ventricular ejection fraction less than 40%
- Age 18-75 years
- BMI greater than 25 kg/m2
- Patients must have undergone a VO2 or exercise stress test within the last 6 months to exclude active ischemia or exercise-induced dysrhythmias
Exclusion
- NYHA IV or 6 minute walk less than 300 meters
- Blood pressure greater than 160/100 mmHg
- Patients undergoing active titration of their cardiac medications
- Other comorbid illnesses which limit expected lifespan or affect the safety of interventions
- Weight loss of more than 10 pounds of non-edematous body weight within the past 3 months
- Pregnancy
- HIV+, active tuberculosis or hepatitis C
- Cancer requiring treatment within the past 5 years, unless the prognosis is excellent
- Unstable angina, myocardial infarction, coronary artery bypass surgery, or angioplasty within the last 3 months
- Angina with exertion
- History of malignant arrythmias (Ventricular Tachycardia / Ventricular Fibrillation) without implanted defibrillator
- Valvular heart disease:
- Symptomatic aortic or mitral stenosis
- Asymptomatic aortic or mitral stenosis that is moderate or greater in severity
- Severe mitral regurgitation
- Hypertrophic cardiomyopathy
- Severe pulmonary hypertension with a pulmonary artery systolic pressure \> 60 mmHg -
- Aortic aneurysm (\>6 cm in diameter)
- Factors that may limit adherence to interventions or affect conduct of the trial
- Unable or unwilling to given informed consent
- Self-report of substance abuse within the past 12 months -
- Failure to comply with the run-in dietary intake and exercise period
- History of bariatric surgery
- Chronic treatment with corticosteroids
- Current diagnosis of schizophrenia, other psychotic disorder, or bipolar disorder
- Current use of medications for weight loss
- Inability to walk two blocks
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00297154
Start Date
March 1 2005
End Date
June 1 2009
Last Update
March 3 2020
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