Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction

NCT ID: NCT02046044

Last Updated: 2014-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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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

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

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ivabradine

Intervention Type DRUG

Digoxin

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

Group Type EXPERIMENTAL

Digoxin

Intervention Type DRUG

Interventions

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Digoxin

Intervention Type DRUG

Ivabradine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Kurtulus Karauzum

Kurtulus Karauzum

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kurtulus Karauzum, MD

Role: PRINCIPAL_INVESTIGATOR

Kocaeli University

Locations

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Kocaeli University

Kocaeli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Kurtulus Karauzum, MD

Role: CONTACT

90 555 726 87 90

Facility Contacts

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Kurtulus Karauzum, MD

Role: primary

90 555 726 87 90

Other Identifiers

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KK&DU-Iva-Dig2014

Identifier Type: -

Identifier Source: org_study_id

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