Left Atrium Reservoir Function Modulation in Patients With Atrial Fibrillation: Digoxin Versus Beta Blocker

NCT05540600 | Unknown Phase 3 DMC

• 1 other identifier: TN2022-NAT-I NS-86
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

ß blocker and digoxin effect on left atrium reservoir function are unknown. This is a randomized open label study to compare the effect of theses two molecules on left atrium function

Conditions

Atrial Fibrillation; Left Atrial Rhythm

Outcome Measures

Primary Outcomes (1)

• Left atrium reservoir strain before and after treatment

  Measurements of Left atrium reservoir strain will be performed at randomization and after 4 weeks on 4 chambers and 2 chamber views according to the most recent recommendations. The acquisition of strain-2D curves will be made by taking as a reference the beginning of the QRS complex. The peak of the curve corresponds to the value of the reservoir strain of the left atrium

  4 weeks

Study Arms (2)

Digoxin group

EXPERIMENTAL

Patients will receive digoxin 0.25 mg once daily for a duration of 4 weeks

Drug: Digoxin 0.25 mg

beta blocker group

EXPERIMENTAL

Patients will receive bisoprolol 2.5 mg or 5 m twice a day for a duration of 4 weeks. The choice of dose will depend on blood pressure (BP): If systolic BP ≥ 150 mmHG, the patient will have bisoprolol 5 mg x 2 per day, If systolic BP \< 150 mmHG, the patient will have bisoprolol 2.5 mg x 2 per day

Drug: Bisoprolol

Interventions

Digoxin 0.25 mg DRUG

Patients will have the dose of one tablet of 0.25mg per day

Digoxin group

Bisoprolol DRUG

Patients will have the dose of bisoprolol 2.5 mg or 5 mg twice a day based on the arterial pressure at randomization

beta blocker group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient with atrial fibrillation naïve to ß-blocker and digoxin or patients followed for Atrial fibrillation and discontinued all treatment for more than a week.
• Frequency Control Strategy Decided
• Age over 18 years
• Stable hemodynamic state
• No contraindication to digoxin or ß-blocker

You may not qualify if:

• Required rhythm control strategy
• Contraindication to one of the two
• Heart rate \<60 BPM
• Clearance rénale \<30 ml/mn
• Pregnant or breastfeeding woman
• Persistence of a resting heart rate \> 110
• Severe comorbidity with decreased life expectancy (advanced neoplasia, large stroke...)

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Fattouma Bourguiba University hospital

Monastir, Tunisia

RECRUITING

Related Publications (5)

• Kotecha D, Bunting KV, Gill SK, Mehta S, Stanbury M, Jones JC, Haynes S, Calvert MJ, Deeks JJ, Steeds RP, Strauss VY, Rahimi K, Camm AJ, Griffith M, Lip GYH, Townend JN, Kirchhof P; Rate Control Therapy Evaluation in Permanent Atrial Fibrillation (RATE-AF) Team. Effect of Digoxin vs Bisoprolol for Heart Rate Control in Atrial Fibrillation on Patient-Reported Quality of Life: The RATE-AF Randomized Clinical Trial. JAMA. 2020 Dec 22;324(24):2497-2508. doi: 10.1001/jama.2020.23138.

  PMID: 33351042 BACKGROUND

• Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P, Agewall S, Camm J, Baron Esquivias G, Budts W, Carerj S, Casselman F, Coca A, De Caterina R, Deftereos S, Dobrev D, Ferro JM, Filippatos G, Fitzsimons D, Gorenek B, Guenoun M, Hohnloser SH, Kolh P, Lip GY, Manolis A, McMurray J, Ponikowski P, Rosenhek R, Ruschitzka F, Savelieva I, Sharma S, Suwalski P, Tamargo JL, Taylor CJ, Van Gelder IC, Voors AA, Windecker S, Zamorano JL, Zeppenfeld K. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur J Cardiothorac Surg. 2016 Nov;50(5):e1-e88. doi: 10.1093/ejcts/ezw313. Epub 2016 Sep 23. No abstract available.

  PMID: 27663299 BACKGROUND

• Ziff OJ, Kotecha D. Digoxin: The good and the bad. Trends Cardiovasc Med. 2016 Oct;26(7):585-95. doi: 10.1016/j.tcm.2016.03.011. Epub 2016 Mar 31.

  PMID: 27156593 BACKGROUND

• Badano LP, Kolias TJ, Muraru D, Abraham TP, Aurigemma G, Edvardsen T, D'Hooge J, Donal E, Fraser AG, Marwick T, Mertens L, Popescu BA, Sengupta PP, Lancellotti P, Thomas JD, Voigt JU; Industry representatives; Reviewers: This document was reviewed by members of the 2016-2018 EACVI Scientific Documents Committee. Standardization of left atrial, right ventricular, and right atrial deformation imaging using two-dimensional speckle tracking echocardiography: a consensus document of the EACVI/ASE/Industry Task Force to standardize deformation imaging. Eur Heart J Cardiovasc Imaging. 2018 Jun 1;19(6):591-600. doi: 10.1093/ehjci/jey042.

  PMID: 29596561 BACKGROUND

• Bouchahda N, Bader M, Najjar A, Mghaieth Zghal F, Sassi G, Mourali MS, Ben Messaoud M. Effect of Digoxin vs Beta-Blockers on Left Atrial Strain for Heart Rate-Controlled Atrial Fibrillation: The DIGOBET-AF Randomized Clinical Trial. Am J Cardiovasc Drugs. 2025 May;25(3):411-418. doi: 10.1007/s40256-024-00705-w. Epub 2024 Dec 26.

  PMID: 39725795 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Digoxin; Bisoprolol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Nidhal Bouchahda, MD

  Monastir university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nidhal Bouchahda, MD

CONTACT

+21696755261; nidhalbouchahda@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: September 12, 2022
• Primary Completion: January 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)