Overview

Rate Control in Atrial Fibrillation II

Status:
Active, not recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
Summary
The RATAF II study is a randomized, prospective, parallel group study, designed to compare the effects of two different drug regimens for rate control in permanent AF (atrial fibrillation). We will investigate on the difference in effects on exercise capacity, biomarkers (NT-proBNP (N-terminal pro-brain natriuretic peptide), troponins, hs-CRP), heart rate, echocardiographic measurements and symptoms. Our main hypothesis is that six months' treatment with the calcium channel blocker diltiazem will lower NT-proBNP and increase exercise capacity (peak VO2) compared to treatment with the beta blocker metoprolol in permanent AF.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asker & Baerum Hospital
Collaborators:
Helse Sor-Ost
Vestre Viken Hospital Trust
Treatments:
Adrenergic beta-1 Receptor Antagonists
Diltiazem
Metoprolol
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Criteria
Inclusion Criteria:

- Above 18 years of age

- Symptomatic, permanent AF of at least three months duration

- Resting heart rate ≥80 bpm

- Signed informed consent

Exclusion Criteria:

- Congestive heart failure

- Ischemic heart disease

- Hypotension (Systolic blood pressure <100 mmHg)

- Treatment with class I or III antiarrhythmic drugs

- Severe hepatic or renal failure

- Pregnancy or lactation

- Hypersensitivity or contradictions to study drugs

- Atrio-ventricular conduction disturbances

- Thyrotoxicosis

- Life limiting disease or substance abuse which may affect participation