Atrial Fibrillation, Heart Failure
Conditions
Keywords
Digoxin, Ivabradine, Cardiac failure, Economics
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.
Interventions
DRUGDigoxin and ivabradine
No more details
Sponsors
Cardiology Office, Rheinfelden, Switzerland
Cocco, Giuseppe, M.D.
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to 78 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac function (diastolic and systolic function) | After 12-14 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea. | After 12-14.weeks | Changes in dyspnea NYHA class). |
| NB-proBNP value | After 12-14 weeks | Changes (serum values) after therapy. |
| Body weight | 12-14. weeks | Changes after therapy |
| Left atrial size | After 12-14 weeks | Change (size). |
| Heart rate and blood pressure. | After 12-14 weeks | Changes in heart rate and blood pressure. |
| Laboratory | After 12-14 weeks | Any changes in hematology, electrolytes, renal and hepatic function. |
| Side-effects | After 12-14 weeks | Any side-effects, spontaneously reported or after specific questionining. |
| 6-min walk test | After 12-14 weeks. | Changes in length of the walk test and heart rate during the test. |
| ECG | After 12-14 weeks | Changes (heart rate,PR-interval, QRS morphology and duration), ST-T segment, other arrhythmias |
Countries
Switzerland
Outcome results
None listed