Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction

Comparing the Effects of Digoxin and Ivabradine on Mortality and Morbidity in Chronic Heart Failure With Reduced Ejection Fraction and Sinus Rhythm

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02046044

Acronym

DIVA-REF

Enrollment

Registered

2014-01-27

Start date

2014-01-31

Completion date

2014-10-31

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, Digoxin, Ivabradine

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.

Interventions

DRUGDigoxin

DRUGIvabradine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame
Hospitalization for a cardiovascular reason	Up to 6 months

Countries

Turkey (Türkiye)

Contacts

Primary ContactKurtulus Karauzum, MD

kurtuluskarauzum@yahoo.com90 555 726 87 90

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026