Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function

Completed

• Conditions: Atrial Fibrillation; Heart Failure
• Interventions: Drug: Digoxin and ivabradine

• Registration Number: NCT01796093
• Lead Sponsor: Cocco, Giuseppe, M.D.

Brief Summary

This is an investigator-started study. The trial is coded as no. GC\&PJ-Dig-Iva2009-2012.

The authors have no conflict of interest and there was no financial sponsoring The study was planned according to the Good Clinical Quality standards using an intention-to-treat analysis. The protocol was approved from the ethics committee. Selected patients gave their written informed consent. The family practitioners agreed and obtained the collected data and analysis. Analysis of collected data was performed by a single-blinded author (without knowledge of the used test drug and time of collection of data).

Study Hypothesis: Compare the effect of digoxin and ivabradine in chronic heart failure with permanent atrial fibrillation (ischemic etiology).

Multiple Time Frames: Primary Outcome is measured before and after each medical intervention.

Measurements at baseline and after 3 month of therapy (twice, with the 2 different drugs):

Measurements Severity of dyspnea. Digoxin serum concentration. ECG: Heart rate at rest and during 6-min walking test. Cardiac function (echocardiography): systolic function (ejection rate, left trial size,diastolic function.

Participants were followed (ambulatory observation) for at least 3 months

Detailed Description

Selected patients had chronic coronary artery disease which had been treated with percutaneous dilatation \& stenting and/or aortocoronary bypass. The severity of myocardial ischemia had induced heart failure with diastolic dysfunction and preserved systolic function, and permanent AF.

1 Inclusion criteria:

Dyspnea class III NYHA.

Abnormal left ventricular relaxation with preserved (≥52%) ejection fraction (LVEF).

Patients either in sinus rhythm or with permanent atrial fibrillation.

2. Exclusion criteria:

Unstable angina pectoris.

Reduced systolic cardiac function (LVEF\<52%).

Normal diastolic function.

Diabetes requiring insulin.

Moderate or severe renal or hepatic dysfunction.

Technically insufficient echocardiography.

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2013-02-19
• Study First Posted: 2013-02-21
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

No need to change concomitant pharmacological therapy in the following months, dyspnea class III NYHA, and abnormal left ventricular relaxation with preserved (≥52%) left ventricular ejection fraction (LVEF).

Exclusion Criteria

Unstable myocardial ischemia, reduced systolic cardiac function (LVEF<52%), diabetes mellitus requiring insulin, moderate or severe renal or hepatic dysfunction, or technically insufficient echocardiography.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Digoxin cross-over ivabradine	Digoxin and ivabradine	Digoxin 0,125 mg once a day 5 days per week during 3 months. Ivabradine, 7,5 mg b.id. during 3 months.

Primary Outcome Measures

Name	Time	Method
Cardiac function (diastolic and systolic function)	After 12-14 weeks	Cardiac function (echocardiography): systolic function (i.e. LVEF) and diastolic function (Doppler E/A ratio, tissue Doppler e/e1 ratio, Doppler deceleration time of the E wave.

Secondary Outcome Measures

Name	Time	Method
NB-proBNP value	After 12-14 weeks	Changes (serum values) after therapy.
ECG	After 12-14 weeks	Changes (heart rate,PR-interval, QRS morphology and duration), ST-T segment, other arrhythmias
6-min walk test	After 12-14 weeks.	Changes in length of the walk test and heart rate during the test.
Heart rate and blood pressure.	After 12-14 weeks	Changes in heart rate and blood pressure.
Dyspnea.	After 12-14.weeks	Changes in dyspnea NYHA class).
Body weight	12-14. weeks	Changes after therapy
Left atrial size	After 12-14 weeks	Change (size).
Laboratory	After 12-14 weeks	Any changes in hematology, electrolytes, renal and hepatic function.
Side-effects	After 12-14 weeks	Any side-effects, spontaneously reported or after specific questionining.

Trial Locations

Locations (1)

Cardiology office; 🇨🇭 Rheinfelden, Argovia, Switzerland