Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function

NCT01796093 | Completed DMC

• 2 other identifiers: GC&PJ-Dig-Iva-2009-2012Cocco G, M.D.
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure; Atrial Fibrillation

Keywords

Digoxin; Ivabradine; Cardiac failure; Economics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Heart rate and blood pressure.

  After 12-14 weeks

• Dyspnea.

  After 12-14.weeks

• NB-proBNP value

  After 12-14 weeks

• Body weight

  12-14. weeks

• Left atrial size

  After 12-14 weeks

Study Arms (1)

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

Interventions

Digoxin and ivabradine DRUG

No more details

Also known as: Medical therapy in heart failure with atrial fibrillation., Drugs used: digoxin and ivabradine.

Digoxin cross-over ivabradine

Eligibility Criteria

• Age: 60 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Unstable myocardial ischemia, reduced systolic cardiac function (LVEF\<52%), diabetes mellitus requiring insulin, moderate or severe renal or hepatic dysfunction, or technically insufficient echocardiography.

Sponsors & Collaborators

• Cocco, Giuseppe, M.D.: lead
• Cardiology Office, Rheinfelden, Switzerland: collaborator

Study Sites (1)

Cardiology office

Rheinfelden, Canton of Aargau, CH-4310, Switzerland

Location

Related Publications (1)

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

  RESULT

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Interventions

Digoxin; Ivabradine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Giuseppe Cocco, MD

  Cardiologist, senior lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., FESC

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: February 21, 2013
• Study Start: April 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

CH (1)