Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)
Condition: Heart Failure
MeSH terms: Heart Failure; Arrhythmias, Cardiac
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to generate effectiveness data of ARNI, in the Chinese HFrEF
      patients with implanted ICD or CRT-D. This will be a multicenter, interventional, open-label,
      and prospective single-arm study to evaluate the effect of ARNI on VAs in approximately 219
      HFrEF patients receiving ICD or CRT-D in China.
    

Detailed description: 
      The rationale of this study is to compare the effect of ACEI/ARB with the effect of ARNI on
      VA events for HFrEF patients with ICD or CRT-D, thus a multicenter, interventional,
      open-label, and prospective single-arm study was considered.

      Study design:This will be a multicenter, interventional, open-label, and prospective
      single-arm study to evaluate the effect of ARNI on VAs in approximately 219 HFrEF patients
      receiving ICD or CRT-D in China.

      After the patient is informed and asked to sign an informed consent form, baseline data will
      be collected. Device data of patients will be collected for 12 months. ACEI/ARB will be given
      to the patient for 6 months. Dosage of ACEI/ARB will be based on investigator's discretion
      and up titrated after 2-4 weeks to the maximum dosage the patients can tolerate and according
      to product label.After 6 months, patients using ACEI need to undergo a 36-hr washout period
      (36-hr washout period is not needed for patients using ARB at month 6). Patients will then
      receive ARNI (sponsored by Novartis only for this study) while the dosage of ARNI will be
      according to investigator's discretion and up titrated to the maximum dosage the patient can
      tolerate or 200 mg bid as per guideline.All patients will be followed up for 6 months for
      each treatment. After patients finalize the trial, the investigator will evaluate all
      patients and produce a report.

      Primary objective of this study is to assess the proportion of patients with VA events over 6
      months of ACEI/ARB and 6 months of ARNI treatment.

      Secondary Objectives include:To assess numbers of occurrences of VA events and ICD or CRT-D
      shocks over 6 months of ACEI/ARB and 6 months of ARNI treatment; To compare the changes in
      LVEF and NYHA level between ACEI/ARB and ARNI treatment; To compare the changes in the
      NT-proBNP level between ACEI/ARB and ARNI treatments; To compare the healthcare resource
      utilization of HF patients during ACEI/ARB and ARNI treatments;
    

Intervention name(s): ACEI/ARB; ARNI
Intervention type(s): Drug; Drug
Intervention description(s): initative ACE/ARB drug for 6 months in this study; initative ARNI drug for next 6 months in this study
Other intervention name(s): Entresto
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LCZ696; sacubitril/valsartan; Heart Failure; Heart failure with reduced ejection fraction; HFrEF; Ventricular arrhythmias; Implanted Device; Healthcare resource utilization