Multicenter study to evaluate the effect and safety of Ivabradine compared to Digoxin in the control of heart rate in patients with permanent atrial fibrillation.
- Conditions
- Heart rate control in patients with chronic atrial fibrillation.MedDRA version: 20.0Level: LLTClassification code 10071668Term: Permanent atrial fibrillationSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-001936-23-ES
- Lead Sponsor
- Dr. Adolfo Fontenla Cerezuela
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1. Age equal to or greater than 18 years.
2. Permanent FA at the time of randomization, with no prospect of cardioversion, antiarrhythmic treatment with group I or III drugs, or pulmonary vein ablation.
3. Symptoms attributable to AF associated with the presence of at least one of the following inadequate FC control criteria:
a) HR at rest> 110 bpm (on ECG performed in the 14 days prior to inclusion).
b) HR at rest between 80 and 110 bpm (on ECG performed in the 14 days prior to inclusion) and at least one of the following criteria:
i. HR in exercise of moderate intensity> 130 bpm (measured in an ergometry or in a Holter-ECG performed in the 60 days prior to inclusion).
ii. Average daytime HR = 80 bpm (measured on a Holter-ECG performed in the 60 days prior to inclusion).
4. Be receiving treatment with beta-blockers or non-dihydropyridine calcium channel blockers (verapamil or diltiazem) at the maximum dose recommended or tolerated by the patient.
5. Be able to voluntarily give their informed consent (the subject himself, his legal representative or an impartial witness).
6. Blood test carried out in the 6 months prior to inclusion, including: blood count, thyroid hormones and creatinine, in order to rule out secondary causes of poor FC control. The creatinine figure will be used to calculate the creatinine clearance in order to adjust the dose of patients who are randomized to the Digoxin group.
7. Transthoracic echocardiogram to rule out, eg, severe valvular heart disease, hypertrophic cardiomyopathy. The one performed in the year prior to inclusion in the study will be considered acceptable provided that the patient's clinical situation has been stable in that period of time.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
1. Previous treatment or known contraindication to Ivabradine or Digoxin.
2. Paroxysmal or intermittent complete AV block in patients not carrying a pacemaker.
3. Decompensated heart failure requiring inotropic and / or intravenous diuretics in the week prior to randomization or in NYHA functional class IV or on the cardiac transplant waiting list.
4. Acute pericarditis, acute myocarditis or constrictive pericarditis.
5. Obstructive hypertrophic cardiomyopathy.
6. Valvular disease requiring surgical or percutaneous correction.
7. Medical causes that justify poor control of heart rate: fever, anemia, hyperthyroidism, pheochromocytoma, etc.
8. Severe hypotension (blood pressure <90/50 mmHg).
9. Concomitant treatment with potent cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, oral erythromycin, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone.
10. Severe renal insufficiency (CrCl <30 ml / Kg / min) or in a hemodialysis program.
11. Severe hepatic insufficiency.
12. Major surgery (including cardiac surgery) in the month prior to randomization.
13. Severe concomitant illness that supposes a life expectancy of less than one year.
14. Impossibility of carrying out scheduled visits to the protocol.
15. Suspected pregnancy or confirmed pregnancy.
16. Participation in a clinical trial in the previous 6 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method