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

Comparison of Digoxin and 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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Atrial Fibrillation
• Intervention / Treatment: 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
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 b.id. 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Cocco, Giuseppe, M.D.
• Collaborators: Cardiology Office, Rheinfelden, Switzerland
• Investigators: Principal Investigator: Giuseppe Cocco, MD, Cardiologist, senior lecturer

Publications and helpful links

General Publications

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

Study record dates

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 5, 2012
• First Submitted That Met QC Criteria: February 19, 2013
• First Posted (Estimate): February 21, 2013

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Ivabradine; Digoxin; Economics; Cardiac failure
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Digoxin
• Other Study ID Numbers: GC&PJ-Dig-Iva-2009-2012; Cocco G, M.D. (Other Grant/Funding Number: Cocco G, MD)