drugset / Trial / NCT04491136

Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)

NCT04491136 ↗

Phase 4 Terminated 201 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study was to generate effectiveness data of Angiotensin receptor neprilysin inhibitor (ARNI), in the Chinese Heart failure with reduced ejection fraction (HFrEF) patients with implantable cardioverted defibrillator (ICD) or Cardiac resynchronization therapy-defibrillator (CRT-D).

Timeline

Start
2020-11-11
Primary completion
2023-06-08
Completion
2023-06-08

Outcome

Missed primary endpoint

Stopped: “Company decision”

registry analysis (other test); ACEI/ARB vs ARNI; p >0.9999; McNemar NCT04491136 ↗

registry analysis (other test); ACEI/ARB vs ARNI; p = 0.7905; McNemar NCT04491136 ↗

registry analysis (other test); ACEI/ARB vs ARNI; p = 0.6250; McNemar NCT04491136 ↗

registry analysis (other test); ACEI/ARB vs ARNI; p = 0.0654; McNemar NCT04491136 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject sacubitril/valsartan Unknown 200 mg Oral

Indications