Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518694
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-21
Brief Title:
Beta-blOckers discoNtinuation in Patients Presenting Heart FaIlure With REcovered Left Ventricular Ejection Fraction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Beta-blOckers discoNtinuation in Patients Presenting Heart FaIlure With REcovered Left Ventricular Ejection Fraction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BONFIRE
Brief Summary:
A significant proportion of patients initially diagnosed with heart failure and a reduced left ventricular ejection fraction LVEF40 HFrEF presents a substantial improvement in response to evidence-based medical and device therapies Some of these patients estimated from 20 to 30 even display a complete normalization of LVEF ie 50 and are now recognized as a specific sub-group of patients named Heart Failure with recovered Ejection Fraction HFrecovEF Different studies have shown that reverse remodeling with recovery of cardiac function and stabilization of HF symptoms are associated with improved clinical outcomes over the long-term Whether these patients present a stable remission of HF and could benefit a therapeutic de-escalation is however unclear Until novel data are provided medical therapies are thus continued indefinitely in these stable patients with HFrecovEF Current guidelines for the management of patients with heart failure and a reduced left ventricular ejection fraction recommends a comprehensive therapy including 5 different therapeutic classes RAAS blockers with a preference for ARNi Beta-Blockers SGLT2i Mineraloreceptors Antagonists or - Diuretics
None of these therapies with the recent exception of one SGLT2i ie Dapagliflozin have been tested in patients with HFrecovEF In addition it is unclear whether the benefit of older therapies notably beta-blockers remains in patients receiving modern comprehensive therapy as newer drugs were tested as add-on therapies This polypharmacy is lowering adherence and is creating a challenge for physicians and patients Betablockers are notably associated with frequent side effects a limited tolerance and a significant reduction of quality of life Their efficacy on outcomes is not established in patients with normal LVEF Pilot studies have suggested that Beta-blockers interruption in patients with HF and normal EF was associated with functional improvement
None of these therapies with the recent exception of one SGLT2i ie Dapagliflozin have been tested in patients with HFrecovEF In addition it is unclear whether the benefit of older therapies notably beta-blockers remains in patients receiving modern comprehensive therapy as newer drugs were tested as add-on therapies This polypharmacy is lowering adherence and is creating a challenge for physicians and patients Betablockers are notably associated with frequent side effects a limited tolerance and a significant reduction of quality of life Their efficacy on outcomes is not established in patients with normal LVEF Pilot studies have suggested that Beta-blockers interruption in patients with HF and normal EF was associated with functional improvement
Detailed Description:
BONFIRE is a National Multicenter Randomised Open-label Non-inferiority Blinded endpoints prospective trial
The study concerns HF patients with a history of reduced left ventricular ejection fraction 45 or below but with a normalized LVEF currently 50 on cardiac echography under an optimal medical therapy as recommended in European guidelines including beta-blockers RAAS blockade with ARNI or ACE-I or ARBs SGLT2 inhibitors MRA or - loop diuretics AND with no or mild symptoms and no heart failure-related events within the last six months
The patients fulfilling the full inclusion criteria and without exclusion criteria that agree to participate the protocol and that have signed the informed consent will be randomized 11 into two groups
Experimental group N650 Βeta-Blockers therapy will be discontinued with tapering while the remaining guideline-directed optimal medical therapy for HF is maintained
Control group N650 The patients will continue their usual guideline-directed optimal medical therapy for HF including Βeta-Blockers therapy without modification
The study concerns HF patients with a history of reduced left ventricular ejection fraction 45 or below but with a normalized LVEF currently 50 on cardiac echography under an optimal medical therapy as recommended in European guidelines including beta-blockers RAAS blockade with ARNI or ACE-I or ARBs SGLT2 inhibitors MRA or - loop diuretics AND with no or mild symptoms and no heart failure-related events within the last six months
The patients fulfilling the full inclusion criteria and without exclusion criteria that agree to participate the protocol and that have signed the informed consent will be randomized 11 into two groups
Experimental group N650 Βeta-Blockers therapy will be discontinued with tapering while the remaining guideline-directed optimal medical therapy for HF is maintained
Control group N650 The patients will continue their usual guideline-directed optimal medical therapy for HF including Βeta-Blockers therapy without modification
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None