A Multicenter, Interventional, Open-label and Single-arm Study to Investigate the Effect of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D

CLCZ696BCN04

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.

2020-11-11

2023-06-08

2023-06-08

Terminated

Early phase I

201

Key Inclusion criteria: 1. Male or female patients ≥18 and ≤80 years of age 2. Implanted with an ICD or CRT-D within 2 weeks 3. NYHA functional class II - IV 4. LVEF ≤40% (measured by echocardiography) 5. Signed informed consent must be obtained prior to participation in the study. Key Exclusion criteria 1. History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes. 2. Patient received target dose (≥200 mg/d) of ARNI for 2 weeks continuously within the 6-week period prior to study enrollment. 3. Participation in other clinical studies 3 months prior to participating study. 4. Advanced cancer or other significant comorbidities with life expectancy of \<1 year. 5. Previous history of angioedema associated with ACEI/ARB treatment, hereditary or idiopathic angioedema. 6. Patients with renal artery stenosis history. 7. Current stage D HF patients requiring vasoactive drugs. 8. Symptomatic hypotension \< 100/60 mmHg at visit 1 (screening) or Symptomatic hypotension \< 90/60 mmHg in anti-hypertension drug treatment at visit 1 (screening). 9. Serum potassium \>5.4 mmol/L at visit 1 (screening). 10. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2 as measured at visit 1 (screening). 11. Pregnant or nursing (lactating) women. 12. Other exclusion depend on investigator's discretion. Other protocol- defined inclusion/exclusion criteria may apply

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 201, 'type': 'ACTUAL'}}

2024-02-21