RATe control in Atrial Fibrillation II

Phase 1

• Conditions: Permanent atrial fibrillation; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-001918-98-NO
• Lead Sponsor: Vestre Viken HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-09
• Last Update Posted: 25 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

- Above 18 years of age
- Permanent, symptomatic AF of at least 3 months duration
- Resting herat rate =80 bpm
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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

- Hypersensitivity of contraindication to study drug(s).
- Treatment with class I or III antiarrhythmic drugs.
- Congestive herat failure.
- Ischemic heart disease.
- Hypotension (Systolic blood pressure <100 mmHg)
- AV-conduction disturbances.
- Thyreotoxicosis.
- Severe hepatic og renal failure.
- Life-limiting disease or substance abuse which may affect participation.
- Pregnancy og lactation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified