Heart FailurePhase 3BONFIRENCT06518694
Beta-blOckers discoNtinuation in Patients Presenting Heart FaIlure With REcovered Left Ventricular Ejection Fraction
A Phase 3 study testing Βeta-Blockers discontinued (with tapering) in people with Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A significant proportion of patients initially diagnosed with heart failure and a reduced left ventricular ejection fraction (LVEF<40%, HFrEF) presents a substantial improvement in response to evidence-based medical and device therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Βeta-Blockers discontinued (with tapering)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2025to Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years-old
- Established diagnosis of HF for more than 12 months, from an ischemic or a non-ischemic origin
- With a documented history of reduced left ventricular ejection fraction (LVEF ≤ 45%), followed by a normalisation of LVEF (≥ 50 % for the last 6 months) assessed by cardiac echography.
- With a left ventricular end diastolic volume indexed to body surface area (LVEDVi) within the normal range (≤74ml/m2 in men and ≤61 ml/m2 in women)
- No or mild symptoms of HF (defined as NYHA functional class I or II)
- No heart failure-related hospital admission within the last six months
Show all 12Show fewer
- Currently receiving a beta-blocker indicated for chronic heart failure (i.e. bisoprolol or carvedilol or metoprolol or nebivolol) whatever the dose used, for at least 12 months
- And receiving the guideline-directed optimal medical therapy for at least 12 months (i.e., maximal tolerated dose of SGLT2 inhibitors, and of RAAS blocker (Angiotensin receptor neprilysin inhibitor OR Angiotensin-converting-enzyme-inhibitors OR Angiotensin II receptors blockers), and MRA if tolerated). Loop diuretics use is adjusted to congestive signs according to physicians' decision.
- No initiation or major adjustment in heart failure therapies should have occurred during the 3 months prior to study inclusion.
- With or without ICD
- Ability to provide written informed consent to participate to the study
- Patient affiliated to Social Security
Who cannot join
- Atrial, supra-ventricular, or ventricular arrhythmias, in the last 12 months and/or requiring beta-blockers according to investigator.
- Uncontrolled arterial hypertension according to investigator decision.
- Symptomatic angina or evidence of infra-clinic myocardial ischemia requiring beta-blockers according to investigator decision.
- Cardiac resynchronization therapy
- Extra-cardiac conditions requiring beta-blockers (migraine, essential tremor, prevention of bleeding from esophageal varices in patients with liver cirrhosis, adrenergic symptoms of hyperthyroidism…) according to investigator decision.
- History of severe outcomes at beta-blockers interruption: HF relapse, occurrence of arrythmias
Show all 16Show fewer
- Severe valvulopathy, restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, or acute myocarditis within 3 months prior to inclusion Visit.
- Planned coronary, carotid, or peripheral artery revascularization known at the day of inclusion
- Chronic renal failure with eGFR <20mL/Min per 1.73m² (CKD-Epi) at inclusion
- Hepatic insufficiency classified as Child-Pugh B or C at the inclusion Visit.
- Any past solid organ transplantation or planned organ transplantation within 12 months
- Any condition other than HF that could limit survival to less than one year
- Pregnancy or breastfeeding women or women of childbearing potential without adequate contraceptive method
- Current participation in another interventional trial.
- Patient under legal protection (protection of the court, or in curatorship or guardianship).
- Any disorder, unwillingness or inability, which in investigator's opinion, might jeopardise the patient's safety or compliance with the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Européen Georges Pompidou
Paris, IDF, 75015
Jean Sébastien HULOT, MD, PhD, 01 56 09 20 17, jean-sebastien.hulot@aphp.fr
About this study
A significant proportion of patients initially diagnosed with heart failure and a reduced left ventricular ejection fraction (LVEF<40%, 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 (i.e., >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, i.e. 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.
Read the 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 (1:1) into two groups:
- Experimental group (N=650): Βeta-Blockers therapy will be discontinued (with tapering) while the remaining guideline-directed optimal medical therapy for HF is maintained.
- Control group (N=650): The patients will continue their usual guideline-directed optimal medical therapy for HF, including Βeta-Blockers therapy, without modification.
- Conditions
- Heart Failure
- Being tested
- Βeta-Blockers discontinued (with tapering)
- Keywords
- Heart Failure relapse, Recovered Ejection Fraction, Cardiovascular outcomes, Hospitalization for CV reason, Death, Bisoprolol, Carvedilol, Metoprolol, Nebivolol, Randomized
- Medical subject headings
- Heart Failure, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Βeta-Blockers discontinued (with tapering)Drug
The experimental group will undergo discontinuation of their beta-blockers treatment during the study period.
The tapering of beta-blocker will start on the day after randomisation and is based on a reduction by half-dose every 48 hours (1/2 maximally recommended dose for 48 hours, then ¼ maximally recommended dose for 48 hours) until reaching the minimal recommended dosage (1/8 maximally recommended dose) for 48 hours before complete interruption of treatment. Consequently, the tapering will not be needed in patients already receiving the minimal recommended dosage (i.e., 1/8 dose) at inclusion, and these patients will be instructed to stop taking beta-blockers the day after randomisation.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | Βeta-Blockers therapy will be discontinued (with tapering) while the remaining guideline-directed optimal medical therapy for HF is maintained Receives: Drug: Βeta-Blockers discontinued (with tapering) |
| Group2 | No intervention | The patients will continue their usual guideline-directed optimal medical therapy for HF, including Βeta-Blockers therapy, without modification. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study will be evaluated with one-year minimum follow-up and will be the composite of:
- HF relapse (at any time during the study period):
- drop in LVEF >10% (expressed as absolute value)
- relative increase in body surface area-indexed left ventricular end-diastolic volume (LVEDVi) >10%
- increase in NT-proBNP >2x and ≥ 400 ng/L
- worsening heart failure symptoms requiring hospitalization or urgent visits or out-of-hospital therapeutic management with diuretics (intra-venous or oral).
Measured: Within 1 year minimum after randomization
death
All-cause death
Measured: Within 1 year minimum after randomization
Hospitalisation for CV reason
- Hospitalisation for CV reason (ACS or need for coronary catheterization +/- revascularization / supra-ventricular arrhythmias / ventricular arrhythmias / Syncope, Pace-Maker implantation / High blood pressure / Stroke).
Measured: Within 1 year minimum after randomization
Secondary outcomes (26)
HF relapse defined by:
- Reduction in LVEF by more than 10% (absolute value)
- A relative increase in LVEDVi by more than 10%
- A two-fold rise in baseline NT-pro-BNP concentration and to more than 400 ng/L.
- Clinical evidence of heart failure, based on signs and symptoms as adjudicated by the research team.
- Hospitalization for worsening HF
Measured: At each visit from randomization through study completion, an average of 4 years
Death
All-cause Death
Measured: At each visit from randomization through study completion, an average of 4 years
All individual reasons for Hospitalisation, as follows:
- ACS or need for coronary catheterisation +/-revascularization
- Recurrent ischemia
- Supra-ventricular or ventricular arrhythmias
- Syncope, PM implantation
- High blood pressure
- Stroke
Measured: At each visit from randomization through study completion, an average of 4 years
Cardiovascular death
All-cause cardiovascular death
Measured: At each visit from randomization through study completion, an average of 4 years
Number of patients with reduction in LVEF
Number of patients with reduction in LVEF by more than 10% (absolute value) and to less than 50%.
Measured: At each visit from randomization through study completion, an average of 4 years
Number of patients with a relative increase in LVEDVi
Number of patients with a relative increase in LVEDVi by more than 10% and to higher than the normal range.
Measured: At each visit from randomization through study completion, an average of 4 years
Number of patients hospitalized
Number of patients hospitalized for worsening HF
Measured: At each visit from randomization through study completion, an average of 4 years
Number of patients needing loop diuretics
Number of patients needing loop diuretics for congestive symptoms, during hospitalization and/or in out-of-hospital settings
Measured: At each visit from randomization through study completion, an average of 4 years
Changes in NYHA Class
Changes in NYHA Class
Measured: At each visit from randomization through study completion, an average of 4 years
Absolute values of NT-pro-BNP concentrations at the different visits
Absolute values of NT-pro-BNP concentrations at the different visits
Measured: At each visit from randomization through study completion, an average of 4 years
Proportion of patients with changes in NT-proBNP concentrations to more than 400 ng/L.
Proportion of patients with changes in NT-proBNP concentrations to more than 400 ng/L.
Measured: At each visit from randomization through study completion, an average of 4 years
Number of patients needing beta-blocker re-introduction in the experimental group or beta-blocker discontinuation in the control group
Number of patients needing beta-blocker re-introduction in the experimental group or beta-blocker discontinuation in the control group
Measured: At each visit from randomization through study completion, an average of 4 years
Occurrence of arrhythmic events (any types, i.e., supra-ventricular and/or ventricular arrhythmias & requiring hospitalization or not) in all participants
Occurrence of arrhythmic events (any types, i.e., supra-ventricular and/or ventricular arrhythmias \& requiring hospitalization or not) in all participants
Measured: At each visit from randomization through study completion, an average of 4 years
Occurrence of infra-clinic supra-ventricular and/or ventricular arrhythmias in patients implanted with ICD before participating the study
Occurrence of infra-clinic supra-ventricular and/or ventricular arrhythmias in patients implanted with ICD before participating the study
Measured: At each visit from randomization through study completion, an average of 4 years
Quality of life (QoL) evaluated by the auto-questionnaire (EQ5D)
Quality of life (QoL) evaluated by the auto-questionnaire (EQ5D)
Measured: At each visit from randomization through study completion, an average of 4 years
Quality of life with heart failure, evaluated by the auto-questionnaire KCCQ-12 filled by the patients himself.
Quality of life with heart failure, evaluated by the auto-questionnaire KCCQ-12 filled by the patients himself.
Measured: At each visit from randomization through study completion, an average of 4 years
Anxiety
questionnaire HADS (Hospital Anxiety and Depression Scale), score de 0 à 21, higher scores indicate the presence of anxiety or depression
Measured: At each visit from randomization through study completion, an average of 4 years
Erectile dysfunction (in men only)
Erectile dysfunction (in men only) by the questionnaire IIEF5 (International Index of Erectile Function).
Measured: At each visit from randomization through study completion, an average of 4 years
Absolute values of heart rate at the different visits
Absolute values of heart rate at the different visits and relative change as compared to baseline values (first year)
Measured: At each visit from randomization through study completion, an average of 4 years
Evaluation of Side effects: Questionnaire on the Presence of Blury Vision
Questionnaire on the Presence of Blury Vision
Measured: At each visit from randomization through study completion, an average of 4 years
Evaluation of Side effects: Sensation of cold hands and feet
Sensation of cold hands and feet
Measured: At each visit from randomization through study completion, an average of 4 years
Evaluation of Side effects : Insomnia
Insomnia
Measured: At each visit from randomization through study completion, an average of 4 years
Occurrence of Palpitations
Occurrence of Palpitations
Measured: At each visit from randomization through study completion, an average of 4 years
Syncope / Dizziness requiring a consultation
Syncope / Dizziness requiring a consultation
Measured: At each visit from randomization through study completion, an average of 4 years
Evaluation of adherence to therapies evaluated by self-questionnaire
Evaluation of adherence to therapies evaluated by self-questionnaire
Measured: At each visit from randomization through study completion, an average of 4 years
Exercise capacity by 6M walk test (in participating centers)
Exercise capacity by 6M walk test (in participating centers)
Measured: At each visit from randomization through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start11 Feb 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National, Multicenter, Randomised, Open-label, Non-inferiority, Blinded endpoints prospective trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Sébastien HULOT, MD,PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518694
- Sponsor's protocol ID
- APHP230833
- Other IDs
- P-PHRC-22-0112
- Acronym
- BONFIRE
- Status last verified
- Jan 2026
- First submitted
- 21 Jun 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-blOckers discoNtinuation in Patients Presenting Heart FaIlure With REcovered Left Ventricular Ejection Fraction
- ClinicalTrials.gov ID
- NCT06518694
- Acronym / sponsor ID
- BONFIRE / APHP230833
- Conditions
- Heart Failure
- Keywords
- Heart Failure relapse, Recovered Ejection Fraction, Cardiovascular outcomes, Hospitalization for CV reason, Death, Bisoprolol, Carvedilol, Metoprolol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A significant proportion of patients initially diagnosed with heart failure and a reduced left ventricular ejection fraction (LVEF<40%, 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 (i.e., >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, i.e. 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 (1:1) into two groups:
- Experimental group (N=650): Βeta-Blockers therapy will be discontinued (with tapering) while the remaining guideline-directed optimal medical therapy for HF is maintained.
- Control group (N=650): The patients will continue their usual guideline-directed optimal medical therapy for HF, including Βeta-Blockers therapy, without modification.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- National, Multicenter, Randomised, Open-label, Non-inferiority, Blinded endpoints prospective trial
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Drug: Βeta-Blockers discontinued (with tapering)Βeta-Blockers therapy will be discontinued (with tapering) while the remaining guideline-directed optimal medical therapy for HF is maintained |
| Group2 | No intervention | –The patients will continue their usual guideline-directed optimal medical therapy for HF, including Βeta-Blockers therapy, without modification. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years-old
- Established diagnosis of HF for more than 12 months, from an ischemic or a non-ischemic origin
- With a documented history of reduced left ventricular ejection fraction (LVEF ≤ 45%), followed by a normalisation of LVEF (≥ 50 % for the last 6 months) assessed by cardiac echography.
- With a left ventricular end diastolic volume indexed to body surface area (LVEDVi) within the normal range (≤74ml/m2 in men and ≤61 ml/m2 in women)
- No or mild symptoms of HF (defined as NYHA functional class I or II)
Key exclusion criteria (16 listed)
- Atrial, supra-ventricular, or ventricular arrhythmias, in the last 12 months and/or requiring beta-blockers according to investigator.
- Uncontrolled arterial hypertension according to investigator decision.
- Symptomatic angina or evidence of infra-clinic myocardial ischemia requiring beta-blockers according to investigator decision.
- Cardiac resynchronization therapy
- Extra-cardiac conditions requiring beta-blockers (migraine, essential tremor, prevention of bleeding from esophageal varices in patients with liver cirrhosis, adrenergic symptoms of hyperthyroidism…) according to investigator decision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Βeta-Blockers discontinued (with tapering)The experimental group will undergo discontinuation of their beta-blockers treatment during the study period. The tapering of beta-blocker will start on the day after randomisation and is based on a reduction by half-dose every 48 hours (1/2 maximally recommended dose for 48 hours, then ¼ maximally recommended dose for 48 hours) until reaching the minimal recommended dosage (1/8 maximally recommended dose) for 48 hours before complete interruption of treatment. Consequently, the tapering will not be needed in patients already receiving the minimal recommended dosage (i.e., 1/8 dose) at inclusion, and these patients will be instructed to stop taking beta-blockers the day after randomisation. | Drug | Group1 |
Primary outcome
The primary endpoint of the study will be evaluated with one-year minimum follow-up and will be the composite of:
Time frame: Within 1 year minimum after randomization
- HF relapse (at any time during the study period): * drop in LVEF >10% (expressed as absolute value) * relative increase in body surface area-indexed left ventricular end-diastolic volume (LVEDVi) >10% * increase in NT-proBNP >2x and ≥ 400 ng/L * worsening heart failure symptoms requiring hospitalization or urgent visits or out-of-hospital therapeutic management with diuretics (intra-venous or oral).
death
Time frame: Within 1 year minimum after randomization
All-cause death
Hospitalisation for CV reason
Time frame: Within 1 year minimum after randomization
- Hospitalisation for CV reason (ACS or need for coronary catheterization +/- revascularization / supra-ventricular arrhythmias / ventricular arrhythmias / Syncope, Pace-Maker implantation / High blood pressure / Stroke).
26 secondary outcomes
HF relapse defined by:
Time frame: At each visit from randomization through study completion, an average of 4 years
Death
Time frame: At each visit from randomization through study completion, an average of 4 years
All individual reasons for Hospitalisation, as follows:
Time frame: At each visit from randomization through study completion, an average of 4 years
Cardiovascular death
Time frame: At each visit from randomization through study completion, an average of 4 years
Number of patients with reduction in LVEF
Time frame: At each visit from randomization through study completion, an average of 4 years
Number of patients with a relative increase in LVEDVi
Time frame: At each visit from randomization through study completion, an average of 4 years
Number of patients hospitalized
Time frame: At each visit from randomization through study completion, an average of 4 years
Number of patients needing loop diuretics
Time frame: At each visit from randomization through study completion, an average of 4 years
Changes in NYHA Class
Time frame: At each visit from randomization through study completion, an average of 4 years
Absolute values of NT-pro-BNP concentrations at the different visits
Time frame: At each visit from randomization through study completion, an average of 4 years
Proportion of patients with changes in NT-proBNP concentrations to more than 400 ng/L.
Time frame: At each visit from randomization through study completion, an average of 4 years
Number of patients needing beta-blocker re-introduction in the experimental group or beta-blocker discontinuation in the control group
Time frame: At each visit from randomization through study completion, an average of 4 years
Occurrence of arrhythmic events (any types, i.e., supra-ventricular and/or ventricular arrhythmias & requiring hospitalization or not) in all participants
Time frame: At each visit from randomization through study completion, an average of 4 years
Occurrence of infra-clinic supra-ventricular and/or ventricular arrhythmias in patients implanted with ICD before participating the study
Time frame: At each visit from randomization through study completion, an average of 4 years
Quality of life (QoL) evaluated by the auto-questionnaire (EQ5D)
Time frame: At each visit from randomization through study completion, an average of 4 years
Quality of life with heart failure, evaluated by the auto-questionnaire KCCQ-12 filled by the patients himself.
Time frame: At each visit from randomization through study completion, an average of 4 years
Anxiety
Time frame: At each visit from randomization through study completion, an average of 4 years
Erectile dysfunction (in men only)
Time frame: At each visit from randomization through study completion, an average of 4 years
Absolute values of heart rate at the different visits
Time frame: At each visit from randomization through study completion, an average of 4 years
Evaluation of Side effects: Questionnaire on the Presence of Blury Vision
Time frame: At each visit from randomization through study completion, an average of 4 years
Evaluation of Side effects: Sensation of cold hands and feet
Time frame: At each visit from randomization through study completion, an average of 4 years
Evaluation of Side effects : Insomnia
Time frame: At each visit from randomization through study completion, an average of 4 years
Occurrence of Palpitations
Time frame: At each visit from randomization through study completion, an average of 4 years
Syncope / Dizziness requiring a consultation
Time frame: At each visit from randomization through study completion, an average of 4 years
Evaluation of adherence to therapies evaluated by self-questionnaire
Time frame: At each visit from randomization through study completion, an average of 4 years
Exercise capacity by 6M walk test (in participating centers)
Time frame: At each visit from randomization through study completion, an average of 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean Sébastien HULOT, MD,PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Βeta-Blockers discontinued (with tapering) in people with Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Sébastien HULOT, MD, PhD (01 56 09 20 17, jean-sebastien.hulot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study will be evaluated with one-year minimum follow-up and will be the composite of: (time frame: Within 1 year minimum after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.