Phase 3 Completed N=6,505 Randomized Quadruple-blind Treatment

Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study

Heart Failure

Source: ClinicalTrials.gov NCT02441218 ↗

Enrolled (actual)

6,505

Serious AEs

43.9%

Results posted

Jun 2015

Primary outcomePrimary: Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure. — 793; 937 participants — p=<0.0001

Summary

The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently receiving recommended therapy for this disease.

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.	793; 937	<0.0001 sig
SECONDARY Cardiovascular Death	449; 491	0.128
SECONDARY Hospitalisation for Worsening Heart Failure	514; 672	< 0.0001 sig
SECONDARY All-cause Mortality	503; 552	0.092
SECONDARY Death From Heart Failure	113; 151	0.0140 sig
SECONDARY Hospitalisation for Any Cause	1231; 1356	0.0027 sig
SECONDARY Hospitalisation for Cardiovascular Reason	977; 1122	0.0002 sig
SECONDARY Unplanned Hospitalisation for Any Cause	1137; 1264	0.0013 sig
SECONDARY Unplanned Hospitalisation for CV Reason	909; 1047	0.0002 sig
SECONDARY Secondary Composite Endpoint	825; 979	< 0.0001 sig

Eligibility Criteria

Inclusion Criteria

Symptomatic Chronic heart failure (NYHA II, III or IV)
Left ventricular systolic dysfunction (LVEF ≤ 35%)
Sinus rhythm and resting heart rate ≥ 70 bpm
Optimal and unchanged CHF medications or dosages

Exclusion Criteria

Unstable condition within previous 4 weeks
Myocardial infarction or coronary revascularisation within previous 2 months
Stroke or transient cerebral ischaemia within previous 4 weeks
Congenital heart disease
Severe valvular disease
Active myocarditis
Permanent atrial fibrillation or flutter

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02441218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.