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

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

ClinicalTrials.gov Identifier: NCT04491136

Novartis Reference Number: CLCZ696BCN04

Last Update: Jan 11, 2021

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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 275 HFrEF patients receiving ICD or CRT-D in China.

Condition 
Heart Failure
Phase 
Phase 4
Overall status 
Recruiting
Enrollment count 
275 participants
Start date 
Nov 11, 2020
Completion date 
Aug 31, 2022
Gender 
All
Age(s)
18 Years - 80 Years (Adult, Older Adult)

Interventions

Drug
ACEI/ARB
initative ACE/ARB drug for 6 months in this study
Drug
ARNI
initative ARNI drug for next 6 months in this study

Eligibility Criteria

Key Inclusion criteria:

Male or female patients ≥18 and ≤80 years of age
Implanted with an ICD or CRT-D within 2 weeks
NYHA functional class II - IV
LVEF ≤40% (measured by echocardiography)
Signed informed consent must be obtained prior to participation in the study.

Key Exclusion criteria

History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical classes.
Patients who received ARNI within 6 weeks prior to study enrollment
Participation in other clinical studies 3 months prior to participating study
Advanced cancer or other significant comorbidities with life expectancy of <1 year
Previous history of angioedema associated with ACEI/ARB treatment, hereditary or idiopathic angioedema
Patients with renal artery stenosis history
Current stage D HF patients requiring vasoactive drugs
Symptomatic hypotension < 100/60 mmHg at Visit 1 (screening) or Symptomatic hypotension < 90/60 mmHg in anti-hypertension drug treatment at Visit 1 (screening)
Serum potassium >5.4 mmol/L at Visit 1 (screening)
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 as measured at Visit 1 (screening)
Pregnant or nursing (lactating) women
Other exclusion depend on investigator's discretion

Other protocol- defined inclusion/exclusion criteria may apply

Study Locations

China
Novartis Investigative Site
Recruiting
Hefei, 230001
An Hui
China
Novartis Investigative Site
Recruiting
Nanjing,
Jiangsu
China
Novartis Investigative Site
Recruiting
Nantong, 226000
Jiangsu
China
Novartis Investigative Site
Recruiting
Wu XI, 214023
Jiangsu
China
Novartis Investigative Site
Recruiting
Shanghai, 200433
Shanghai
China
Novartis Investigative Site
Recruiting
Chengdu, 610031
Sichuan
China
Novartis Investigative Site
Recruiting
Hangzhou, 310014
Zhejiang
China
Novartis Investigative Site
Recruiting
Tianjin, 300000
-
China

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]