Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02046044
• Other study ID #: KK&DU-Iva-Dig2014
• Status: Recruiting
• Phase: Phase 4
• First received: January 20, 2014
• Last updated: January 23, 2014
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: January 2014
• Source: Kocaeli University
• Contact: Kurtulus Karauzum, MD
• Phone: 90 555 726 87 90
• Email: kurtuluskarauzum[@]yahoo.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Digoxin

• Ivabradine

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalization for a cardiovascular reason		Up to 6 months	Yes
Primary	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	After 6 months	No
Secondary	Cardiovascular mortality	Death from cardiovascular reasons	Up to 6 months	Yes
Secondary	All cause mortality	Death from any cause.	Up to 6 months	Yes
Secondary	Hospital admission for worsening heart failure		Up to 6 months	No
Secondary	Heart rate and blood pressure	Changes in heart rate and blood pressure.	After 6 months	Yes