Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function

NCT ID: NCT01796093

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2012-02-29

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.

Conditions

Heart Failure; Atrial Fibrillation

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Digoxin cross-over ivabradine

Digoxin 0,125 mg once a day 5 days per week during 3 months. Ivabradine, 7,5 mg b.id. during 3 months.

Digoxin and ivabradine

Intervention Type: DRUG

No more details

Interventions

Digoxin and ivabradine

No more details

Intervention Type: DRUG

Other Intervention Names

Medical therapy in heart failure with atrial fibrillation.; Drugs used: digoxin and ivabradine.

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiology Office, Rheinfelden, Switzerland

OTHER

Sponsor Role: collaborator

Cocco, Giuseppe, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Cocco G., M.D.

M.D., FESC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe Cocco, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiologist, senior lecturer

Locations

Cardiology office

Rheinfelden, Canton of Aargau, Switzerland

Countries

Switzerland

References

Cocco G, Jerie P. Comparison of digoxin and ivabradine in heart failure with preserved systolic function. Submitted to the American Heart Journal.

Reference Type: RESULT

Other Identifiers

Cocco G, M.D.

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GC&PJ-Dig-Iva-2009-2012

Identifier Type: -

Identifier Source: org_study_id