Efficacy Study of Digoxin & Ivabradine to Treat Heart Failure (Dig&Iva)

November 8, 2013 updated by: Cocco G., M.D., Cocco, Giuseppe, M.D.

Comparison of Digoxin and Ivabradine in Heart Failure With Preserved Systolic Function. Time to Rethink About Digoxin.

It is established that at a serum concentration 0.5-0.9 ng/ml digoxin is effective in patients with heart failure, especially in the presence of atrial fibrillation (AF). It is the claimed that ivabradine by lowering heart rate reduces symptoms and improves clinical outcomes in patients with heart failure. The effect of ivabradine and digoxin in heart failure was compared.

Patients 22 patients with ischemic heart failure, AF, and diastolic dysfunction with preserved left ventricular systolic function were treated with digoxin and ivabradine for 3 months, according to a randomization cross-over design.

Collected data Medical history, physical examination, laboratory (including proBNP and serum digoxin concentrations), ECG, 6-minute walk test, and echocardiographic data (LVEF, LAVi, e/e1 ratio).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Protocol This is an investigator-started study, coded GC&PJ-dig-Iva 2009-2012. The study was planned according to the Good Clinical Quality standards and the analysis was performed using an intention-to-treat method. The protocol was approved from an Ethics Committee. Selected patients gave their written informed consent. The family practitioners agreed and obtained the data and analysis. Collected data were analyzed from single-blinded investigators (without knowledge of the used test drug and time of collection).

Patients Study design: same patients were assigned to DIG or IVA for 3 months, according to a randomization cross-over design.

Tested drugs Commercial brands of digoxin and ivabradine were used. Digoxin was given by mouth at a dose of 0.125 mg/day, 5 times per week, for 3 months.

Ivabradine was given by mouth at a dose of 7.5 mg bid for 3 months.

Inclusion criteria Chronic and stable coronary artery disease Permanent atrial fibrillation. Diastolic dysfunction with maintained systolic function.

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 echocardiographic quality.

Collected data Medical history and concomitant medications. Physical examination was performed. Laboratory values (including proBNP and serum digoxin concentration). ECG. Echocardiography. 6-minute walk test.

Statistical Analyses Data are expressed as mean ± 1 SD. Absolute values and percent changes in relation to baseline measurements were analyzed. The 2 hypotheses tested were: null hypothesis: mu1-mu2=0.0, and alternative hypothesis: mu1-mu2>>0.0. Comparisons within groups were made using paired t tests or the non-parametric Wilcoxon signed-rank test, where appropriate. Between-group comparisons were performed by unpaired t tests or the non-parametric Mann-Whitney U test, respectively. Chi-square test or Kruskal-Wallis test were used to compare continuous normally or not normally distributed and qualitative variables, where appropriate. Multivariate analysis of variance was performed. A p value of < 0.05 was considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Argovia
      • Rheinfelden, Argovia, Switzerland, CH-4310
        • Cardiology office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All patients had heart failure NYHA (New York Heart Association) class III. All had chronic and stable coronary artery disease which had been treated with percutaneous dilatation and stenting, and/or aortocoronary bypass. The pathology had induced a permanent AF and heart failure with left ventricular diastolic dysfunction and preserved systolic function. Preserved systolic function was defined by a LVEF (left ventricular ejection fraction) ≥52%. Left ventricular diastolic dysfunction was defined by a e/e1 ratio > 15 (septal spectral tissue-Doppler).

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ivabradine
Ivabradine, 7,5 mg b.id. by mouth for 14-16 weeks.
Drug: Ivabradine
7.5 my b.id. by mouth for 12-14 weeks
Other Names:
  • Procoralan
Active Comparator: Digoxin
Digoxin 0.125 mg once a day, 5 times per week, for 12-14 weeks by mouth.
Drug: Digoxin
1.25 mg once a day by mouth, for 12-14 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative therapeutic effect.
Time Frame: 6 months
Effects on symptoms and signs of cardiac failure.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cocco, Giuseppe, M.D.

Collaborators

Cardiology Office, Rheinfelden, Switzerland

Investigators

  • Principal Investigator: Giuseppe Cocco, MD, Cardiologist, senior lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

October 3, 2012

First Posted (Estimate)

October 4, 2012

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 8, 2013

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CG&PJ-Dig-Iva 2009-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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