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

September 14, 2022 updated by: Nidhal Bouchahda, University of Monastir

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Tunisia
      • Monastir, Tunisia
        • Recruiting
        • Fattouma Bourguiba University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digoxin group
Patients will receive digoxin 0.25 mg once daily for a duration of 4 weeks
Drug: Digoxin 0.25 mg
Patients will have the dose of one tablet of 0.25mg per day
Experimental: beta blocker group
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
Patients will have the dose of bisoprolol 2.5 mg or 5 mg twice a day based on the arterial pressure at randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left atrium reservoir strain before and after treatment
Time Frame: 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

Investigators

  • Principal Investigator: Nidhal Bouchahda, MD, Monastir university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 14, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TN2022-NAT-I NS-86

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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