ISRCTN78790185CompletedNot Applicable
Heart Failure and Obesity: Effects of Weight Loss (HOW)
Record Provided by the NHSTCT Register - 2006 Update - Department of Health0 sites38 target enrollmentStarted: September 29, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 38
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •38 patients. Pilot study: 6 patients will be recruited for active dietary intervention. Main study: 24 patients will be recruited for the active dietary intervention and 8 patients for the control.
- •1. Obese patients defined at body mass index (BMI) of above 30 and <40 kg/m2 (excessive body weight will preclude exercise and accurate imaging)
- •2. Stable heart failure patients of NHYA (New York Heart Association) class II or III (patients must be able to undertake exercise testing). Diagnosis of heart failure will be based on standard criteria of symptoms of more than 6 months with confirmed LVEF impairment on echocardiogram
- •3. Age above 25 and below 70 years (to ensure patients can participate with the exercise etc)
Exclusion Criteria
- •1. Unable to give informed consent
- •2. Subjects with renal impairment defined by creatinine >170 ?mol/l (inappropriate to include patients with more complex
- •illness in this study).
- •3. Patients with Diabetes Mellitus on antidiabetic medication (other
- •than metformin - diet and weight loss would require alteration of insulin or non-metformin diabetes treatment, complicating assessments)
- •4. Heart failure patients of NHYA (New York Heart Association) class III (patients must be able to undertake exercise testing)
Investigators
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