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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Digoxin
Ivabradine
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Digoxin, Ivabradine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  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

Sites / Locations

  • Kocaeli UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ivabradine

Digoxin

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cardiovascular mortality
Death from cardiovascular reasons
All cause mortality
Death from any cause.
Hospital admission for worsening heart failure
Heart rate and blood pressure
Changes in heart rate and blood pressure.

Full Information

First Posted
January 20, 2014
Last Updated
January 23, 2014
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT02046044
Brief Title
Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction
Acronym
DIVA-REF
Official Title
Comparing the Effects of Digoxin and Ivabradine on Mortality and Morbidity in Chronic Heart Failure With Reduced Ejection Fraction and Sinus Rhythm
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Digoxin, Ivabradine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ivabradine
Arm Type
Experimental
Arm 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.
Arm Title
Digoxin
Arm Type
Experimental
Arm Description
Digoxin: Digoxin 0,25 mg once a day 5 days per week during 6 months.
Intervention Type
Drug
Intervention Name(s)
Digoxin
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Primary Outcome Measure Information:
Title
Cardiac function and functional status and biochemical parameters
Description
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 Outcome Measure Information:
Title
Cardiovascular mortality
Description
Death from cardiovascular reasons
Time Frame
Up to 6 months
Title
All cause mortality
Description
Death from any cause.
Time Frame
Up to 6 months
Title
Hospital admission for worsening heart failure
Time Frame
Up to 6 months
Title
Heart rate and blood pressure
Description
Changes in heart rate and blood pressure.
Time Frame
After 6 months
Other Pre-specified Outcome Measures:
Title
Hospitalization for a cardiovascular reason
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kurtulus Karauzum, MD
Phone
90 555 726 87 90
Email
kurtuluskarauzum@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurtulus Karauzum, MD
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kurtulus Karauzum, MD
Phone
90 555 726 87 90
Email
kurtuluskarauzum@yahoo.com

12. IPD Sharing Statement

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Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction

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