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

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ClinicalTrials.gov Identifier: NCT02046044
Recruitment Status : Unknown
Verified January 2014 by Kurtulus Karauzum, Kocaeli University.
Recruitment status was:  Recruiting
First Posted : January 27, 2014
Last Update Posted : January 27, 2014
Sponsor:
Information provided by (Responsible Party):
Kurtulus Karauzum, Kocaeli University

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Digoxin Drug: Ivabradine Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: Up to 6 months ]
    Death from cardiovascular reasons

  2. All cause mortality [ Time Frame: Up to 6 months ]
    Death from any cause.

  3. Hospital admission for worsening heart failure [ Time Frame: Up to 6 months ]
  4. Heart rate and blood pressure [ Time Frame: After 6 months ]
    Changes in heart rate and blood pressure.


Other Outcome Measures:
  1. Hospitalization for a cardiovascular reason [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046044


Contacts
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Contact: Kurtulus Karauzum, MD 90 555 726 87 90 kurtuluskarauzum@yahoo.com

Locations
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Turkey
Kocaeli University Recruiting
Kocaeli, Turkey
Contact: Kurtulus Karauzum, MD    90 555 726 87 90    kurtuluskarauzum@yahoo.com   
Sponsors and Collaborators
Kocaeli University
Investigators
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Principal Investigator: Kurtulus Karauzum, MD Kocaeli University

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Responsible Party: Kurtulus Karauzum, Kocaeli University
ClinicalTrials.gov Identifier: NCT02046044     History of Changes
Other Study ID Numbers: KK&DU-Iva-Dig2014
First Posted: January 27, 2014    Key Record Dates
Last Update Posted: January 27, 2014
Last Verified: January 2014

Keywords provided by Kurtulus Karauzum, Kocaeli University:
Heart failure
Digoxin
Ivabradine

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs