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Trial · NCT06112743

Registered outcomes18

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

ListOutcomeTime frameDescription
PrimaryComposite of maximum left atrial volume index (LAVI) and left ventricular mass index (LVMI) at Week 48At week 48
Participants achieving both of the following criteria at Week 48 cardiac magnetic resonance imaging (CMR) assessment: * A decrease of at least 5 mL/m2 in maximum LAVI from baseline * A decrease of at least 5 g/m2 in LVMI from baseline
SecondaryProportion of participants who had at least 1 class of improvement from baseline in New York Heart Association (NYHA) class at Week 48At week 48
SecondaryChange from baseline in maximum left atrial volume index (LAVI) at Week 48At week 48
SecondaryChange from baseline in left ventricular mass index (LVMI) at Week 48At week 48
SecondaryIncidence of major adverse cardiac events (MACE)Up to 48 weeks
SecondaryIncidence of MACE-expanded eventsUp to 48 weeks
SecondaryAll-cause mortalityUp to 48 weeks
SecondaryIncidence of heart failure (HF) eventsUp to 48 weeks
SecondaryIncidence of HF events with systolic dysfunctionUp to 48 weeks
SecondaryIncidence of atrial fibrillation (AF)/atrial flutterUp to 48 weeks
SecondaryIncidence of cardiovascular (CV) mortalityUp to 48 weeks
SecondaryIncidence of ventricular tachyarrhythmiasUp to 48 weeks
SecondaryIncidence of nonvasovagal syncope and seizuresUp to 48 weeks
SecondaryIncidence of treatment emergent adverse events (TEAEs)Up to 48 weeks
SecondarySeverity of TEAEsUp to 48 weeks
SecondaryIncidence of treatment emergent serious adverse events (SAEs)Up to 48 weeks
SecondaryTEAEs leading to discontinuation from study interventionUp to 48 weeks
SecondaryTEAEs leading to laboratory abnormalitiesUp to 48 weeks

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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