Propafenone in the Treatment of Atrial Fibrillation

• Status: Completed
• Trial end date: 2021-08-17
• Target enrollment: 0
• Participant gender: All

Summary

This is a open label randomized, multi-center study conducted in Taiwan. The study aims to evaluate the effectiveness and safety of oral Rhynorm (A drug) and Rytmonorm (B drug) for the conversion of paroxysmal AF and is designed to evaluate the improvement in sinus rhythm restoration after the treatment with Rhynorm (A drug) and Rytmonorm (B drug) for 24 weeks.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TSH Biopharm Corporation Limited
• Treatments: Propafenone

Criteria

Inclusion Criteria:

1. Patients who are 20~80 years of age

2. Recurrent AF patients

3. Patients with paroxysmal atrial fibrillation

4. Patients diagnosed with one of the ECG monitoring within 12 months prior screening visit:

1. 12-lead electrocardiogram

2. ECG used to make a 30 second one of recording

3. 24 hours ECG (Holter Monitor)

4. Long term ECG (Event Monitor)

5. Patient may be receiving stable dose of propafenone since at least 4 weeks prior screening visit.

6. Agree to and are able to follow the study procedures

7. Understand the nature of the study, and have signed informed consent forms

Exclusion Criteria:

1. Permanent or persistent AF

2. Any of the following heart disease:

1. New York Heart Association class III or IV angina pectoris or heart failure

2. previous electrocardiographic evidence of second- or third-degree atrioventricular block;

3. Sinus node disease, AV conduction disturbance or bundle branch block in the absence of an artificial pacemaker

4. Hemodynamic moderate valvular heart disease (stenosis and/or incompetent; regurgitation)

5. Brugada syndrome

6. Left ventricular EF< 50%

7. Acute myocardial infarction or unstable angina within the previous 12 months

8. Cardiogenic shock (excluding arrhythrmia shock) within the previous 12 months

9. Acute pericarditis or myocarditis within the previous 6 months

10. Cardiac or thoracic surgery within the previous 6 months

3. Symptomatic Bradycardia (heart rate less than 50 beats per minute)

4. Hemodynamic instability, defined as hypotension (SBP < 90 mm Hg)

5. Hyperthyroidism

6. Bronchospastic disorders or severe obstructive pulmonary disease

7. Correctable AF for other reasons

8. Marked electrolyte imbalance

9. Patients with clinically significant abnormalities in the following laboratory parameters:

1. AST or ALT ≥ 3X upper limit of normal (ULN)

2. Total bilirubin ≥ 2X ULN

3. Creatinine ≥ 2.5 mg/dL

4. Hemoglobin < 10 g/dL

5. Platelet < 100,000/uL

10. Patients with known contraindication or history of allergy to Propafenone.

11. Female patients who are pregnant or lactating.

12. Female patients of child-bearing potentiality who do not agree to use an effective method of contraception during the study

13. Patients currently participating in any drug related clinical trial within 30 days

14. Patients with propagating factor (e.g. Alcohol Abuse induced AF)