Left Atrium Reservoir Function Modulation in Patients With Atrial Fibrillation: Digoxin Versus Beta Blocker
Primary Purpose
Atrial Fibrillation, Left Atrial Rhythm
Status
Recruiting
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Digoxin 0.25 mg
Bisoprolol
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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...)
Sites / Locations
- Fattouma Bourguiba University hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Digoxin group
beta blocker group
Arm Description
Patients will receive digoxin 0.25 mg once daily for a duration of 4 weeks
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05540600
First Posted
September 12, 2022
Last Updated
September 14, 2022
Sponsor
University of Monastir
1. Study Identification
Unique Protocol Identification Number
NCT05540600
Brief Title
Left Atrium Reservoir Function Modulation in Patients With Atrial Fibrillation: Digoxin Versus Beta Blocker
Official Title
Left Atrium Reservoir Function Modulation in Patients With Atrial Fibrillation: A Randomized Digoxin Versus Beta Blocker Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
Atrial fibrillation (AF) is responsible of significant morbidity and mortality. Management of signs and symptoms of heart failure generated by AF is at the center of the latest European recommendations . Mechanisms by which these symptoms are generated are very poorly understood. Heart rate control is one of the recommended strategies but remains poorly codified and generally follows the preferences and experiences of each local center. The European guidelines propose at least 4 molecules for heart rate control without emitting preferences for one molecule over the other due to the lack of robust randomized studies. Recently, a study comparing digoxin vs ß-blockers showed the superiority of digoxin in decreasing symptoms despite a comparable action on heart rate. On the other hand, the reservoir function of the left atrium (LA) has taken a central role in assessing signs of left heart failure and monitoring filling pressures . Other studies have demonstrated the association of left atrium reservoir strain with these symptoms .
It is commonly accepted that ß blockers decrease AF-related symptoms by a negative chronotropic effect thanks to their blocking action on the sympathetic system. While the action of digoxin on symptoms goes through a positive inotropic effect thanks to the increase in intracellular calcium .
However, the impact of these two molecules on the function of the left atrium has never been investigated. Our diagnostic hypothesis is that in addition to their action on heart rate, the improvement of symptoms noted by using b blockers and digoxin during the treatment of AF would go through an improvement LA reservoir function . The superiority of digoxin in the reduction of symptoms compared to ß blockers would be due to a greater improvement in reservoir function and this thanks to the increase in myocardial intracellular calcium.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Left Atrial Rhythm
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digoxin group
Arm Type
Experimental
Arm Description
Patients will receive digoxin 0.25 mg once daily for a duration of 4 weeks
Arm Title
beta blocker group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Digoxin 0.25 mg
Intervention Description
Patients will have the dose of one tablet of 0.25mg per day
Intervention Type
Drug
Intervention Name(s)
Bisoprolol
Intervention Description
Patients will have the dose of bisoprolol 2.5 mg or 5 mg twice a day based on the arterial pressure at randomization
Primary Outcome Measure Information:
Title
Left atrium reservoir strain before and after treatment
Description
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
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nidhal Bouchahda, MD
Phone
+21696755261
Email
nidhalbouchahda@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nidhal Bouchahda, MD
Organizational Affiliation
Monastir university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fattouma Bourguiba University hospital
City
Monastir
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nidhal Bouchahda, MD
Phone
+21696755261
Email
nidhalbouchahda@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33351042
Citation
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.
Results Reference
background
PubMed Identifier
27663299
Citation
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.
Results Reference
background
PubMed Identifier
27156593
Citation
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.
Results Reference
background
PubMed Identifier
29596561
Citation
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. Erratum In: Eur Heart J Cardiovasc Imaging. 2018 Jul 1;19(7):830-833.
Results Reference
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Left Atrium Reservoir Function Modulation in Patients With Atrial Fibrillation: Digoxin Versus Beta Blocker
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