Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
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