Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function (DIGvsIVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01796093
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : February 1, 2017
Cardiology Office, Rheinfelden, Switzerland
Information provided by (Responsible Party):
Cocco G., M.D., 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

Condition or disease Intervention/treatment
Heart Failure Atrial Fibrillation Drug: Digoxin and ivabradine

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 Type : Observational [Patient Registry]
Actual Enrollment : 42 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 4 Months
Official Title: Comparison of Digoxin and Ivabradine in Heart Failure With Preserved Systolic Function.
Study Start Date : April 2008
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Digoxin cross-over ivabradine
Digoxin 0,125 mg once a day 5 days per week during 3 months. Ivabradine, 7,5 mg during 3 months.
Drug: Digoxin and ivabradine
No more details
Other Names:
  • Medical therapy in heart failure with atrial fibrillation.
  • Drugs used: digoxin and ivabradine.

Primary Outcome Measures :
  1. Cardiac function (diastolic and systolic function) [ Time Frame: 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 :
  1. Heart rate and blood pressure. [ Time Frame: After 12-14 weeks ]
    Changes in heart rate and blood pressure.

  2. Dyspnea. [ Time Frame: After 12-14.weeks ]
    Changes in dyspnea NYHA class).

  3. NB-proBNP value [ Time Frame: After 12-14 weeks ]
    Changes (serum values) after therapy.

  4. Body weight [ Time Frame: 12-14. weeks ]
    Changes after therapy

  5. Left atrial size [ Time Frame: After 12-14 weeks ]
    Change (size).

  6. ECG [ Time Frame: After 12-14 weeks ]
    Changes (heart rate,PR-interval, QRS morphology and duration), ST-T segment, other arrhythmias

  7. Laboratory [ Time Frame: After 12-14 weeks ]
    Any changes in hematology, electrolytes, renal and hepatic function.

  8. Side-effects [ Time Frame: After 12-14 weeks ]
    Any side-effects, spontaneously reported or after specific questionining.

  9. 6-min walk test [ Time Frame: After 12-14 weeks. ]
    Changes in length of the walk test and heart rate during the test.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with ischemic heart disease and heart failure with preserved systolic function, dyspnea grade III NYHA. Either in sinus rhythm (and possible paroxismal atrial fibrillation) or with permanent atrial fibrillation.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01796093

Cardiology office
Rheinfelden, Argovia, Switzerland, CH-4310
Sponsors and Collaborators
Cocco, Giuseppe, M.D.
Cardiology Office, Rheinfelden, Switzerland
Principal Investigator: Giuseppe Cocco, MD Cardiologist, senior lecturer

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

Responsible Party: Cocco G., M.D., M.D., FESC, Cocco, Giuseppe, M.D. Identifier: NCT01796093     History of Changes
Other Study ID Numbers: GC&PJ-Dig-Iva-2009-2012
Cocco G, M.D. ( Other Grant/Funding Number: Cocco G, MD )
First Posted: February 21, 2013    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Keywords provided by Cocco G., M.D., Cocco, Giuseppe, M.D.:
Cardiac failure

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs