None listed
Conditions
Brief summary
This local-multicentre, prospective, randomised control study will aim to assess the impact of an intentional weight loss and a prescribed exercise program in overweight and obese patients with heart failure and reduced ejection fraction (HF-REF). The impact of the program will be assessed by the measurement at 12 months of the change in exercise capacity (as measured by peak VO2 on CPET), and the change in KCCQ score compared with baseline measurements. These two parameters will be the composite endpoints. A number of secondary endpoints will be collected to assess the prognostic significance (including mortality, rate of hospitalisations, changes in New York Heart Association Classification (NYHA)), cardiac structural, functional, mood and cardiac biomarker effects of this program. This study aims to assist in clarifying the degree of controversy and uncertainty about the appropriateness of advice to patients with obesity and established HF-REF. This is a result of a recurrently observed, but somewhat controversial ‘obesity paradox’ in a number of heart failure (HF) studies where patients with HF and higher body mass index (BMI) appear to have improved outcomes including less deterioration of functional class and lower mortality rates compared with those who have HF and a lower BMI. There is a paucity of published clinical studies that have assessed the combined effects of an intentional weight loss and prescribed exercise program on heart failure outcomes including functional measures, hospitalisations, mortality, and cardiac structural changes along with measured serum biomarkers. This study will evaluate the effects of a structured lifestyle interventional program compared with standard of care in overweight and obese patients with heart failure and reduced ejection fraction.
Interventions
This study is designed as a prospective, local multi-centre randomised control trial. A total of 150 patients will be randomised in a 1:1 ratio to enrol in a physician-led interventional lifestyle program (pathway A), or standard medical management (pathway B). At the time of consent, all participants will be assigned either Pathway A or B. Depending upon on recruitment rates, the trial may be expanded to other Australian sites.
Group A (Lifestyle and Weight loss intervention):
For patients ra
This study is designed as a prospective, local multi-centre randomised control trial. A total of 150 patients will be randomised in a 1:1 ratio to enrol in a physician-led interventional lifestyle program (pathway A), or standard medical management (pathway B). At the time of consent, all participants will be assigned either Pathway A or B. Depending upon on recruitment rates, the trial may be expanded to other Australian sites. Group A (Lifestyle and Weight loss intervention): For patients randomised to the intervention (Group A), a structured, motivational and goal-directed program using face-to-face physician-led counselling will be used for weight reduction. The overall duration of the intervention is 12 months. This lifestyle intervention clinic will deliver risk factor management to the patient with the help of a research assistant. Patients will be encouraged to utilise support counselling and schedule more frequent reviews as required after the initial intensive phase. Initial weight reduction will be attempted by a meal plan and behaviour modification. Meals plans will consist of high protein and low glycemic index, calorie controlled foods, targeted to a maximum of 1500 calories per day. If patients lose <3% of weight after 3-months they will then be prescribed very-low-calorie (VLCD) meal replacement sachets (Nestle Health Sciences) for 1-2 meals per day with an aim of ~800-1000 calories per day. The initial goal is to reduce body weight by 10%. After patients achieve the initial goal, meal replacement will be substituted to high protein and low glycemic index, calorie-controlled foods to achieve a target BMI of less than, or equal to, 25kg per m2. During periods of prescription of very-low-calorie meal replacement sachets, participants will undergo a protocol of electrolyte monitoring. As recommended on the Nestle Health Sciences product information sheet, patients on diuretics may need the dose reduced or the diuretic ceased altogether as postural hypotension may occur. Patients will be monitored closely, preferably under specialist caer and fluid restrictions will be modified if appropriate to suit individual requirements. Electrolytes will be monitored more frequently (twice per week during the intensive phase). If a study participant is prescribed VLCD, the guidance and assistance of a Clinical Dietician will occur and patients will be reviewed by a Clinical Dietician as they are commenced on this protocol. During the intensive phase of the intervention (the 1st 12 weeks), initially weekly (for the 1st six weeks), and consequently fortnightly visits will be scheduled. The initial visit will be for 45mins to 1 hour, followed by 20 minutes for subsequent visits. After the intensive phase, a tailored program of visits will be scheduled for the duration of the intervention (monthly, or 2-monthly visits). Exercise: The American Heart Association has previously produced a scientific statement that documents the physiological benefits and safety of prescribed exercise in patients with a diagnosis of heart failure. Following the performance of the Cardio-pulmonary exercise test (CPET), a scheduled visit will occur with an Exercise Physiologist. This 45 minute consultation will involve a discussion regarding the results of the CPET and formulation of an individualised exercise plan. The personalised exercise plan will be adapted to an individual's musculoskeletal capacity, their baseline level of fitness and their personal ability to adapt to exercise in their weekly routines. In general terms for this study, low intensity aerobic exercise (walking, cycling, swimming), will be prescribed initially for 20-minutes thrice-weekly (with an aim of 60% of the individuals maximum predicted heart rate). This will then increasing to at least 200-minutes of moderate-intensity activity per week (which will include resistance training). The patients will be advised to maintain a lifestyle journal in which patients log their daily food intake, weight, blood pressure and exercise duration. This journal will be utilized for giving necessary exercise advice and assisting as an effective behavioural tool for modification.
Sponsors
South Australian Health and Medical Research Institute
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Established diagnosis of HF-REF (as defined by the presence of the clinical syndrome of heart failure and documented cardiac systolic dysfunction on cardiac imaging, with a measured left ventricular ejection fraction <45%). • On established medical therapy (not currently undergoing an active phase or program of up-titration of medical therapy). • Age >18 and <80 at the time of enrolment. • BMI >27kg/m2 • New York Heart Association Classification II, III or ambulatory class IV. • > 1 month following a previous admission to hospital with exacerbation or diagnosis of HF
Exclusion criteria
• Current listing for cardiac transplantation or placement of left ventricular assist device. • History of myocardial infarction or cardiac surgery within the previous 3 months. • Frequent hospitalisations with HF (>2 in the previous 6 months). • Significant cardiac valvulopathy (with the exception of functional mitral and tricuspid regurgitation) • Active malignancy, active autoimmune or systemic inflammatory disease; severe renal or hepatic failure. • Acute & potentially reversible causes of HF (eg. Takostubo cardiomyopathy, acute myocarditis). • Unstable ventricular arrhythmias in preceding 3 months • Significant chronic disease that prevents enrolment in the program such as active malignancy, severe pulmonary disease, end-stage renal or hepatic failure, other physical disability resulting in inability to exercise. • Pregnancy.
Outcome results
None listed