Efficacy and Safety Study of F373280

NCT01831856 | Completed Phase 2 Results

• 2 other identifiers: F373280 CA 2 012012-003487-48
• Study Type: interventional
• Target: 135
• Locations: 5 countries
• Sites: 20

Brief Summary

The purpose of this study is to assess the efficacy of F373280 on the maintenance of normal cardiac rhythm after direct electric cardioversion in patients with persistent atrial fibrillation and cardiac failure.

Conditions

Atrial Fibrillation

Keywords

Cardiovascular diseases; Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Time to First Atrial Fibrillation (AF) Recurrence or Atrial Flutter Emergence Defined by the Time to First Episode of AF or Atrial Flutter Lasting for at Least 10 Minutes During the 20-week Follow-up After Visit 3 (Electrical Cardioversion (ECV) Visit).

  Time to first Atrial Fibrillation (AF) recurrence defined by the first episode of Atrial Fibrillation lasting for at least 10 minutes. AF recurrences or atrial flutter emergences: 7-day continuous electrocardiogram (ECG; 5-leads/2 or 3 channels) ambulatory recording (Holter ECG) between Visit 3 (Electrical Cardioversion Visit) and Visit 4 (Week 5). Then, the follow-up was documented using the Transtelephonic ECG monitor (TTEM): one transmission every two days from Week 9 to Week 24. For randomised patients with spontaneous cardioversion before Electrical Cardioversion, the recurrence of AF or the emergence of atrial flutter was assessed after Visit 3 (from Week 5). Moreover, during this TTEM period, if the patient experienced any AF or atrial flutter symptoms, it was recorded and documented using the TTEM.

  from electrical cardioversion (Visit 3) to last follow-up visit (W24)

Study Arms (2)

F373280

EXPERIMENTAL

Drug: 1g of F373280

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

1g of F373280 DRUG

Oral administration, one capsule each evening with dinner.

F373280

Placebo DRUG

Oral administration, one capsule each evening with dinner.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged more than 18 years (inclusive)
• Patients with current episode of persistent Atrial Fibrillation (AF) between 7 days and 6 months duration for whom electrical cardioversion is warranted
• Previous history of first documented episode of persistent AF.
• Previous history of ischemic or non ischemic heart failure
• an increased left ventricular end-diastolic size (diameter ≥ 60 mm and/or \> 32 mm/m² and/or volume \> 97 ml/m²)
• and/or an increased left ventricular end-systolic size (diameter \> 45 mm and/or \> 25 mm/m² and/or volume \> 43 ml/m²)
• and/or a reduced left ventricular outflow tract velocity time integral \< 15 cm
• On appropriate, stable medical treatments for heart failure, including a diuretic and/or angiotensin-converting enzyme, and/or angiotensin-receptor blocker and/or mineralocorticoid receptor (MR) antagonists, and/or betablockers
• Patients treated or having to be treated by vitamin K antagonist
• For female patient of child-bearing potential:
• In all the countries except Italy:
• Use of an effective method of contraception (hormonal contraception or intra-uterine device) assessed by the investigator, for at least 2 months before the selection in the study, and agreement to go on using it during the whole duration of the study and up to 1 month after the last dose of the study treatment
• Documented as surgically sterilized
• In Italy only:
• Absolute abstention from sexual intercourse during the whole duration of the study and for a month after the end of the study or

You may not qualify if:

• No previous history of first documented episode of persistent AF
• More than two successful cardioversions (electrical or pharmacological) in the last 6 months
• Secondary Atrial Fibrillation due to alcohol or severe valvular heart disease (grade III to IV)
• Thyroid disease uncontrolled by treatment: TSH ± T4L ± T3L to be checked in case of treatment for thyroid disease
• Myocardial infarction or unstable angina or presence of unstable ischemic coronaropathy assessed by coronarography or cardiac stress test (Echo stress, exercise stress test, nuclear or MR perfusion evaluation methods) within 6 months before selection
• Severe chronic kidney disease (creatinine ≥ 25 mg/L or estimated glomerular filtration rate \< 30 ml/min) at selection
• Bradycardia (HR ≤ 50 bpm)
• Hyperkalemia or hypokalemia (according to the standards of local laboratories) at selection
• Cardiac surgery within 3 months before selection or planned during the study duration
• Criteria related to treatments:
• Previously ineffective pharmacological or electrical cardioversion
• Concomitant treatment with ranolazine or any antiarrhythmic drug (within 7 days prior to selection), except amiodarone, dronedarone and stable dose of digoxin, betablockers, calcium-blockers
• Concomitant treatment with oral amiodarone or dronedarone from selection
• Concomitant treatment with intravenous amiodarone from selection
• Patient requiring a cardiac resynchronization therapy (CRT) or having undergone CRT implantation within the last 6 months

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (20)

Unknown Facility

Karlovy Vary, Czechia

Location

Unknown Facility

Prague, 128 08, Czechia

Location

Unknown Facility

Praha 5 - Motol, Czechia

Location

Unknown Facility

Budapest, 1023, Hungary

Location

Unknown Facility

Budapest, 1032, Hungary

Location

Unknown Facility

Budapest, 1096, Hungary

Location

Unknown Facility

Budapest, 1122, Hungary

Location

Unknown Facility

Augusta, Italy

Location

Unknown Facility

Brescia, Italy

Location

Unknown Facility

Foggia, Italy

Location

Unknown Facility

Terni, Italy

Location

Unknown Facility

Verona, Italy

Location

Unknown Facility

Grodzisk Mazowiecki, Poland

Location

Unknown Facility

Radom, Poland

Location

Unknown Facility

Sandomierz, Poland

Location

Unknown Facility

Warsaw, 03-242, Poland

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Santiago de Compostela, Spain

Location

Unknown Facility

Tarragona, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Karim KEDDAD, MD, PhD Head of Medical Unit
• Organization: Institut de Recherche Pierre Fabre

Karim.keddad@pierre-fabre.com

+33 5 34 50 61 69

Study Officials

• Karim Keddad, MD

  PierreFabre Medicamment

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 15, 2013
• Study Start: April 1, 2013
• Primary Completion: April 3, 2017
• Study Completion: June 21, 2017
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-06

Locations

HU (4); IT (5); PL (4); ES (4); CZ (3)