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
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Drug: Digoxin Drug: Ivabradine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- Cardiovascular mortality [ Time Frame: Up to 6 months ]Death from cardiovascular reasons
- All cause mortality [ Time Frame: Up to 6 months ]Death from any cause.
- Hospital admission for worsening heart failure [ Time Frame: Up to 6 months ]
- Heart rate and blood pressure [ Time Frame: After 6 months ]Changes in heart rate and blood pressure.
- Hospitalization for a cardiovascular reason [ Time Frame: Up to 6 months ]
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
|Contact: Kurtulus Karauzum, MD||90 555 726 87 email@example.com|
|Contact: Kurtulus Karauzum, MD 90 555 726 87 90 firstname.lastname@example.org|
|Principal Investigator:||Kurtulus Karauzum, MD||Kocaeli University|