Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction

Phase 4UnknownNCT02046044

Kocaeli University60 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

DigoxinDRUG

IvabradineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Cardiac function and functional status and biochemical parameters

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

Time frame: After 6 months

Secondary Outcomes

Cardiovascular mortality

Death from cardiovascular reasons

Time frame: Up to 6 months

All cause mortality

Death from any cause.

Time frame: Up to 6 months

Hospital admission for worsening heart failure

Time frame: Up to 6 months

Heart rate and blood pressure

Changes in heart rate and blood pressure.

Time frame: After 6 months

Central Contacts

Kurtulus Karauzum, MD

CONTACT

90 555 726 87 90 kurtuluskarauzum@yahoo.com

Data from ClinicalTrials.gov

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