Trial · NCT06518694
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary endpoint of the study will be evaluated with one-year minimum follow-up and will be the composite of: | 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). |
| Primary | death | Within 1 year minimum after randomization | All-cause death |
| Primary | Hospitalisation for CV reason | 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). |
| Secondary | HF relapse defined by: | At each visit from randomization through study completion, an average of 4 years | * 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 |
| Secondary | Death | At each visit from randomization through study completion, an average of 4 years | All-cause Death |
| Secondary | All individual reasons for Hospitalisation, as follows: | At each visit from randomization through study completion, an average of 4 years | * ACS or need for coronary catheterisation +/-revascularization * Recurrent ischemia * Supra-ventricular or ventricular arrhythmias * Syncope, PM implantation * High blood pressure * Stroke |
| Secondary | Cardiovascular death | At each visit from randomization through study completion, an average of 4 years | All-cause cardiovascular death |
| Secondary | Number of patients with reduction in LVEF | At each visit from randomization through study completion, an average of 4 years | Number of patients with reduction in LVEF by more than 10% (absolute value) and to less than 50%. |
| Secondary | Number of patients with a relative increase in LVEDVi | At each visit from randomization through study completion, an average of 4 years | Number of patients with a relative increase in LVEDVi by more than 10% and to higher than the normal range. |
| Secondary | Number of patients hospitalized | At each visit from randomization through study completion, an average of 4 years | Number of patients hospitalized for worsening HF |
| Secondary | Number of patients needing loop diuretics | At each visit from randomization through study completion, an average of 4 years | Number of patients needing loop diuretics for congestive symptoms, during hospitalization and/or in out-of-hospital settings |
| Secondary | Changes in NYHA Class | At each visit from randomization through study completion, an average of 4 years | Changes in NYHA Class |
| Secondary | Absolute values of NT-pro-BNP concentrations at the different visits | At each visit from randomization through study completion, an average of 4 years | Absolute values of NT-pro-BNP concentrations at the different visits |
| Secondary | Proportion of patients with changes in NT-proBNP concentrations to more than 400 ng/L. | 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. |
| Secondary | Number of patients needing beta-blocker re-introduction in the experimental group or beta-blocker discontinuation in the control group | 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 |
| Secondary | Occurrence of arrhythmic events (any types, i.e., supra-ventricular and/or ventricular arrhythmias & requiring hospitalization or not) in all participants | 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 |
| Secondary | Occurrence of infra-clinic supra-ventricular and/or ventricular arrhythmias in patients implanted with ICD before participating the study | 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 |
| Secondary | Quality of life (QoL) evaluated by the auto-questionnaire (EQ5D) | At each visit from randomization through study completion, an average of 4 years | Quality of life (QoL) evaluated by the auto-questionnaire (EQ5D) |
| Secondary | Quality of life with heart failure, evaluated by the auto-questionnaire KCCQ-12 filled by the patients himself. | 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. |
| Secondary | Anxiety | At each visit from randomization through study completion, an average of 4 years | questionnaire HADS (Hospital Anxiety and Depression Scale), score de 0 à 21, higher scores indicate the presence of anxiety or depression |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT06518694/registered