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Trial · NCT07288749

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary
A composite endpoint of cardiovascular death, heart transplantation, or worsening heart failure (defined as rehospitalization for heart failure or an emergency heart failure visit requiring intravenous therapy).
3 years
The Primary Outcome is defined as a composite endpoint consisting of the time to the first occurrence of any of the following events: 1. Cardiovascular death is defined as any death due to a direct cardiovascular cause. 2. Heart transplantation is defined as receiving an allogeneic in situ heart transplant due to end-stage heart failure. The event date is defined as the date of surgery. 3. Heart failure exacerbation is defined as requiring intensive treatment due to worsening symptoms and signs of heart failure, meeting any of the following criteria: ① readmission for heart failure; ② urgent heart failure visit requiring intravenous therapy.
SecondaryAll-cause mortality rate3 yearsDeath occurring during the study period for any cause. This is the most objective and unbiased endpoint. All deaths, whether cardiovascular-related or not, are included in this endpoint.
SecondaryCardiovascular death, heart transplantation, or readmission due to heart failure3 yearsTime to the first occurrence of any of the following events: cardiovascular death, heart transplantation, or rehospitalization for heart failure (defined as the primary endpoint).
SecondaryCardiovascular death, heart transplantation3 yearsTime to the first occurrence of any of the following events: cardiovascular death or heart transplantation (defined as the primary endpoint).
SecondaryRehospitalization due to heart failure3 yearsTime to first rehospitalization due to heart failure (defined as the primary endpoint).
SecondaryIncidence of discontinuing treatment due to worsening heart failure3 years
The patient or their family voluntarily decides to forgo aggressive life-sustaining treatment-including intravenous medications, mechanical ventilation, and renal replacement therapy-due to the extremely poor prognosis of heart failure, inability to tolerate treatment, or other reasons, ultimately resulting in the patient's death after treatment is discontinued.
SecondaryRate of successful resuscitation following cardiac arrest3 years
An event where spontaneous circulation is successfully restored for ≥20 minutes following cardiac arrest (defined as pulseless ventricular tachycardia, ventricular fibrillation, or pulseless electrical activity) through cardiopulmonary resuscitation (including defibrillation, external chest compressions, pharmacotherapy, etc.).
SecondaryIncidence of malignant arrhythmias3 years
Clinically significant ventricular arrhythmias confirmed by electrocardiogram, Holter monitoring, or implantable device recordings. Typically includes: sustained ventricular tachycardia (lasting ≥30 seconds or requiring urgent termination due to hemodynamic instability); ventricular fibrillation; ventricular arrhythmias resulting in appropriate electrical therapy (applicable to patients with implantable cardioverter-defibrillators \[ICDs\] or cardiac resynchronization therapy defibrillators \[CRT-Ds\]).
SecondaryRate of serum NT-proBNP decrease3 years
The relative rate of change in serum NT-proBNP levels from baseline to a predetermined study time point (e.g., 3 months, 6 months, or 12 months). Calculation formula: (Follow-up value - Baseline value) / Baseline value × 100%.
SecondaryChanges in Kansas Cardiomyopathy Questionnaire (KCCQ) scores3 years
The absolute change in the KCCQ overall summary score (or domain-specific scores such as physical function, symptom frequency, quality of life, and social limitations) from baseline to a predetermined study time point (e.g., 3 months, 6 months, or 12 months). Calculation Method: Follow-up score - Baseline score.
SecondaryChanges in 6-Minute Walk Test (6MWT) Results3 yearsChange in 6-minute walk distance (6MWD) from baseline to follow-up (in meters).
SecondaryIncidence of non-fatal myocardial infarction or non-fatal stroke3 yearsTime to the first occurrence of either a non-fatal myocardial infarction or a non-fatal stroke.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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.

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