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

January 23, 2014 updated by: Kurtulus Karauzum, Kocaeli University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Ivabradine
Experimental: Digoxin
Digoxin: Digoxin 0,25 mg once a day 5 days per week during 6 months.
Drug: Digoxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac function and functional status and biochemical parameters
Time Frame: 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
After 6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Hospitalization for a cardiovascular reason
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Kurtulus Karauzum, MD, Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

October 1, 2014

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KK&DU-Iva-Dig2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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