Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction

Phase 4

• Conditions: Heart Failure
• Interventions: Drug: Ivabradine; Drug: Digoxin

• Registration Number: NCT02046044
• Lead Sponsor: Kocaeli University

Brief Summary

Study hypothesis: Comparing the effect of digoxin and ivabradine in chronic heart failure patients with a left ventricular ejection of 35% or lower and sinus rhythm with heart rate 70 beats per minute or higher, and who are taking maximal dose of a beta blocker if tolerated.

Detailed Description

Selected patients have chronic heart failure with left ventricular systolic dysfunction and sinus rhythm. They take optimal medical therapy.

Study Timeline

• Status Verified: 2014-01
• Study Start: 2014-01
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-23
• Last Update Submitted: 2014-01-23
• Study First Posted: 2014-01-27
• Last Update Posted: 2014-01-27
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Left ventricular ejection fraction of 35% or lower (Ischaemic or non-ischaemic etiology)
  • Sinus rhythm with heart rate of 70 beats per minute or higher
  • Symptomatic heart failure with functional capacity of New York Heart Association class II, III, IV

Exclusion Criteria

• Chronic renal failure with glomerular filtration rate <30 ml/min
  • Atrial fibrillation
  • Pace maker rhythm
  • Advanced stage chronic obstructive lung disease
  • Comorbidity with expected survival below 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivabradine	Ivabradine	Ivabradine: initial dose of 5 mg b.id. dose up-titration to 7,5 mg b.id. in 2 weeks due to the heart rate and maintaining the last dose during 6 months.
Digoxin	Digoxin	Digoxin: Digoxin 0,25 mg once a day 5 days per week during 6 months.

Primary Outcome Measures

Name	Time	Method
Cardiac function and functional status and biochemical parameters	After 6 months	Cardiac function (echocardiography): Systolic function (left ventricular ejection fraction) and diastolic function (Doppler E/A ratio, tissue Doppler e/e1 ratio, Doppler deceleration time of the E wave, left atrium volume index) Maximal oxygen consumption will be evaluated with cardiopulmonary exercise testing Changes in proBNP level (serum value) after treatment

Secondary Outcome Measures

Name	Time	Method
Cardiovascular mortality	Up to 6 months	Death from cardiovascular reasons
All cause mortality	Up to 6 months	Death from any cause.
Hospital admission for worsening heart failure	Up to 6 months
Heart rate and blood pressure	After 6 months	Changes in heart rate and blood pressure.

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey