Overview

Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function

Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Cocco, Giuseppe, M.D.
Collaborator:
Cardiology Office, Rheinfelden, Switzerland
Treatments:
Digoxin
Criteria
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.