Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT01796093
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
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:
NCT01796093
Study Brief:
Protocol Section:
NCT01796093