Status:
TERMINATED
Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 impl...
Detailed Description
The rationale of this study was to compare the effect of angiotensin-converting enzyme inhibitor (ACEI) / Angiotensin receptor blockers (ARB) with the effect of ARNI on ventricular arrhythmia (VA) eve...
Eligibility Criteria
Inclusion
- 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.
- Patient received target dose (≥200 mg/d) of ARNI for 2 weeks continuously within the 6-week period 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.
Exclusion
Key Trial Info
Start Date :
November 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2023
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT04491136
Start Date
November 11 2020
End Date
June 8 2023
Last Update
May 16 2025
Active Locations (23)
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1
Novartis Investigative Site
Hefei, Anhui, China, 230001
2
Novartis Investigative Site
Beijing, Beijing Municipality, China, 100034
3
Novartis Investigative Site
Beijing, Beijing Municipality, China, 100044
4
Novartis Investigative Site
Fuzhou, Fujian, China, 350001