Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction (DIVA-REF)

Kocaeli University

Status and phase: Unknown; Phase 4

Conditions: Heart Failure

Treatments: Drug: Ivabradine; Drug: Digoxin

Study type: Interventional

Funder types: Other

Identifiers

NCT02046044

KK&DU-Iva-Dig2014

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. 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

2. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Ivabradine

Experimental group

Description:

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.

Treatment:

Drug: Ivabradine

Digoxin

Experimental group

Description:

Digoxin: Digoxin 0,25 mg once a day 5 days per week during 6 months.

Treatment:

Drug: Digoxin