Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Digoxin and Ivabradine in Heart Failure With Preserved Systolic Function.

Conditions
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Heart Failure, Atrial Fibrillation

Intervention / Treatment
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* Drug: Digoxin and ivabradine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Digoxin cross-over ivabradine<br>Digoxin 0,125 mg once a day 5 days per week during 3 months. Ivabradine, 7,5 mg b.id. during 3 months. | Drug: Digoxin and ivabradine<br>* No more details<br>* Other names: Drugs used: digoxin and ivabradine.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac function (diastolic and systolic function) | 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. | After 12-14 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digoxin, Ivabradine, Cardiac failure, Economics