Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function

Heart Failure Clinical Trial

— DIGvsIVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796093
• Other study ID #: GC&PJ-Dig-Iva-2009-2012
• Secondary ID: Cocco G, M.D.
• Status: Completed
• Phase: N/A
• First received: September 5, 2012
• Last updated: January 30, 2017
• Start date: April 2008
• Est. completion date: February 2012

Study information

• Verified date: January 2017
• Source: Cocco, Giuseppe, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 78 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

Drug:
• Digoxin and ivabradine
No more details

Locations

Country	Name	City	State
Switzerland	Cardiology office	Rheinfelden	Argovia

Sponsors (2)

Lead Sponsor	Collaborator
Cocco, Giuseppe, M.D.	Cardiology Office, Rheinfelden, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart rate and blood pressure.	Changes in heart rate and blood pressure.	After 12-14 weeks
Secondary	Dyspnea.	Changes in dyspnea NYHA class).	After 12-14.weeks
Secondary	NB-proBNP value	Changes (serum values) after therapy.	After 12-14 weeks
Secondary	Body weight	Changes after therapy	12-14. weeks
Secondary	Left atrial size	Change (size).	After 12-14 weeks
Secondary	ECG	Changes (heart rate,PR-interval, QRS morphology and duration), ST-T segment, other arrhythmias	After 12-14 weeks
Secondary	Laboratory	Any changes in hematology, electrolytes, renal and hepatic function.	After 12-14 weeks
Secondary	Side-effects	Any side-effects, spontaneously reported or after specific questionining.	After 12-14 weeks
Secondary	6-min walk test	Changes in length of the walk test and heart rate during the test.	After 12-14 weeks.