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Completed

NCT Number: NCT01796093

Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function

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

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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year–78 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology office

Rheinfelden, Canton of Aargau, CH-4310, Switzerland

About this study

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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digoxin and ivabradine

Drug

No more details

Other names: Medical therapy in heart failure with atrial fibrillation., Drugs used: digoxin and ivabradine.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Cocco, Giuseppe, M.D.

Indiv

Collaborators

  • Cardiology Office, Rheinfelden, Switzerland

Registry information

Official study title

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

Acronym: DIGvsIVA

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 21, 2013
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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