Heart Failure and Obesity: Effects of Weight Loss (HOW)

Completed

Conditions: utritional, Metabolic, Endocrine: Obesity
Nutritional, Metabolic, Endocrine
Obesity

Registration Number: ISRCTN78790185

Lead Sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 38

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak oxygen consumption during cardiopulmonary exercise testing (Peak VO2) following acute weight loss (week 6) and weight loss maintenance phase(16 weeks)

Secondary Outcome Measures