Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423599
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-16
Brief Title:
Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure
Sponsor:
Jens D Hove MDPHD
Organization:
Hvidovre University Hospital
Study Overview
Official Title:
Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIT-HF
Brief Summary:
The benefit of weight loss in patients with obesity and heart failure with reduced ejection fraction HFrEF is controversial Semaglutide has shown cardiovascular CV risk-reduction and impact on CV risk factors including overweight dysglycaemia and hypertension in subjects with type 2 diabetes T2D The STEP-HFpEF Semaglutide Treatment Effect in People With Obesity and HFpEF recently demonstrated at 1-year to not only reduce weight considerably but also significantly improve health-related quality of life functional status scores and 6-min walk distance in patients with heart failure with preserved ejection fraction HFpEF Also the recently concluded SELECT trial was the first CV outcome trial with semaglutide in patients with overweight or obesity and established CV disease including heart failure but no T2D Semaglutide demonstrated a 20 reduction in MACE defined as the composite of cardiovascular death non-fatal myocardial infarction and non-fatal stroke
These landmark findings have important implications for clinicians -as they mean that weight loss andor semaglutide as anti-obesity pharmacotherapy could be a treatment strategy for secondary prevention of CV disease in patients with overweight or obesity
It is however unknown whether weight loss with either calorie-restricted diet or semaglutide has beneficial effects in obese subjects with heart failure and reduced ejection fraction Also it is unclear whether semaglutide has cardiovascular benefits irrespective of starting weight and amount of weight loss
Purpose The study aims to investigate whether weight loss treatment with semaglutide is superior to weight loss with calorie-restricted diet in improving peak oxygen uptake in patients with obesity and heart failure with reduced ejection fraction
These landmark findings have important implications for clinicians -as they mean that weight loss andor semaglutide as anti-obesity pharmacotherapy could be a treatment strategy for secondary prevention of CV disease in patients with overweight or obesity
It is however unknown whether weight loss with either calorie-restricted diet or semaglutide has beneficial effects in obese subjects with heart failure and reduced ejection fraction Also it is unclear whether semaglutide has cardiovascular benefits irrespective of starting weight and amount of weight loss
Purpose The study aims to investigate whether weight loss treatment with semaglutide is superior to weight loss with calorie-restricted diet in improving peak oxygen uptake in patients with obesity and heart failure with reduced ejection fraction
Detailed Description:
Background The prevalence of overweight and obesity has reached pandemic proportions Obesity is known to increase the risk for Type 2 diabetes and hypertension as well as the risk for overt cardiovascular CV disease including myocardial infarction heart failure and stroke The rising prevalence of obesity may counteract the recent advances in primary and secondary prevention of CV disease Overweight and obesity are common in patients with CV disease however cardiologists face several challenges in managing body weight in this population Many may not consider obesity as a therapeutic target probably because there were no previous highly effective and safe pharmacologic interventions to consider In addition they may not have the expertise or resources to implement lifestyle interventions and may have limited familiarity with obesity pharmacotherapy Moreover the long-term CV effects of obesity pharmacotherapy remain uncertain due to limited CV outcome data with weight loss as the primary intervention Although current CV guidelines recognize the importance of weight loss they primarily focus on lifestyle modifications with fewer details on strategies to utilize obesity pharmacotherapy and surgery However the recent 2022 American Diabetes AssociationEuropean Association for the Study of Diabetes consensus on the management of Type 2 diabetes has moved up weight management to the front of the treatment algorithm by prioritizing the use of pharmacologic interventions such as glucagon-like peptide-1 receptor agonists and dual glucose-dependent insulinotropic polypeptideglucagon-like peptide-1 receptor agonists which have potent weight-lowering effects in addition to glucose-lowering effects
Hypothesis The investigators hypothesise that weight loss treatment with semaglutide is superior to weight loss with state-of-the-art calorie-restricted diet in improving the peak oxygen uptake mlminkg after 52 weeks as a marker of physical performance and with prognostic implications in patients with obesity and heart failure with reduced ejection fraction
Design This is a investigator-initiated parallel-group 2-arm assessor-blinded open-label randomised controlled trial RCT comparing the effect of weight loss using low-calorie replacement diet to weight loss using semaglutide in obese patients with heart failure with reduced ejection fraction Subjects will be randomised in a 11 ratio to receive either low-calorie replacement diet or semaglutideThe subjects wil be followed for 52 weeks during the intervention period The patients will be examined at 16 weeks where the weight loss is anticipated to be approximately equal in the two groups and after 52 weeks
Primary secondary and exploratory objectives are listed below The exploratory objectives are mostly embedded mechanistic studies of an exploratory nature and therefore hypothesis-generating in the RCT
Intervention Subjects will be treated with semaglutide once weekly or a weight loss intervention consisting of a calorie-restricted diet and dietary advice on top of standard of care which covers management of heart failure medication CV risk factors and healthy lifestyle counselling
Hypothesis The investigators hypothesise that weight loss treatment with semaglutide is superior to weight loss with state-of-the-art calorie-restricted diet in improving the peak oxygen uptake mlminkg after 52 weeks as a marker of physical performance and with prognostic implications in patients with obesity and heart failure with reduced ejection fraction
Design This is a investigator-initiated parallel-group 2-arm assessor-blinded open-label randomised controlled trial RCT comparing the effect of weight loss using low-calorie replacement diet to weight loss using semaglutide in obese patients with heart failure with reduced ejection fraction Subjects will be randomised in a 11 ratio to receive either low-calorie replacement diet or semaglutideThe subjects wil be followed for 52 weeks during the intervention period The patients will be examined at 16 weeks where the weight loss is anticipated to be approximately equal in the two groups and after 52 weeks
Primary secondary and exploratory objectives are listed below The exploratory objectives are mostly embedded mechanistic studies of an exploratory nature and therefore hypothesis-generating in the RCT
Intervention Subjects will be treated with semaglutide once weekly or a weight loss intervention consisting of a calorie-restricted diet and dietary advice on top of standard of care which covers management of heart failure medication CV risk factors and healthy lifestyle counselling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-503753-35-01 | CTIS | None | None |