Digoxin Versus Ivabradine in Heart Failure With Preserved Systolic Function (DIGvsIVA)
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
Cardiac Failure With Sinus Rhythm or Atrial Fibrillation.
Drug: Digoxin and ivabradine
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Prospective
|Target Follow-Up Duration:||4 Months|
|Official Title:||Comparison of Digoxin and Ivabradine in Heart Failure With Preserved Systolic Function.|
- Cardiac function (diastolic and systolic function) [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: No ]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.
- Heart rate and blood pressure. [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: No ]Changes in heart rate and blood pressure.
- Dyspnea. [ Time Frame: After 12-14.weeks ] [ Designated as safety issue: No ]Changes in dyspnea NYHA class).
- NB-proBNP value [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: No ]Changes (serum values) after therapy.
- Body weight [ Time Frame: 12-14. weeks ] [ Designated as safety issue: No ]Changes after therapy
- Left atrial size [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: No ]Change (size).
- ECG [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: Yes ]Changes (heart rate,PR-interval, QRS morphology and duration), ST-T segment, other arrhythmias
- Laboratory [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: Yes ]Any changes in hematology, electrolytes, renal and hepatic function.
- Side-effects [ Time Frame: After 12-14 weeks ] [ Designated as safety issue: Yes ]Any side-effects, spontaneously reported or after specific questionining.
- 6-min walk test [ Time Frame: After 12-14 weeks. ] [ Designated as safety issue: No ]Changes in length of the walk test and heart rate during the test.
|Study Start Date:||April 2008|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
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
No more details
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01796093
|Rheinfelden, Argovia, Switzerland, CH-4310|
|Principal Investigator:||Giuseppe Cocco, MD||Cardiologist, senior lecturer|