TerminatedPhase 4

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

Stopped: Company decision

China201 participantsStarted 2020-11-11

Plain-language 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).

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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).

What they're measuring

Proportion of Paired Patients With Ventricular Arrhythmia (VA) Events

Timeframe: Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)

Proportion of Paired Patients Who Experienced at Least One ICD or CRT-D Shock and ATP Event

Timeframe: Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)

Trial details

NCT IDNCT04491136

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-08

Results submitted2024-06-03

View on ClinicalTrials.gov More Heart Failure trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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).

What they're measuring

Proportion of Paired Patients With Ventricular Arrhythmia (VA) Events

Timeframe: Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)

Proportion of Paired Patients Who Experienced at Least One ICD or CRT-D Shock and ATP Event

Timeframe: Up to 12 months (6 months of ACEI/ARB treatment and 6 months of ARNI treatment)