Plasma Aldosterone Levels and Atrial Fibrillation Reduction (ALDO-AF Study) (ALDO-AF)

Atrial fibrillation (AF) is the most common cardiac arrhythmias with a constantly growing prevalence. Two main techniques are used today to restore sinus rhythm: electrical cardioversion and radiofrequency ablation.

Radiofrequency ablation has become a recognized and effective treatment of AF. Despite a relatively high success rate (about 80%), a substantial number of patients require a second procedure to obtain sinus rhythm. Many publications have led to the study of predictors of failure of this ablation factors (BMI, uncontrolled hypertension, size of the OG...) but to date no parameter is reliable and usable in daily practice.

It is the same for electrical cardioversion. Despite a relatively high immediate success rate of approximately 80%, a significant number of patient relapse arrhythmia in short and long term. Many publications have led to the study of predictive factors of failure (seniority and type of AF, uncontrolled hypertension, size of the OG, mitral valve disease...) but so far the results are disappointing.

In AF patients with heart disease underlying, it has been well demonstrated that the renin-angiotensin system (RAAS) was strongly activated. In addition, it is now well established that elevated plasma aldosterone as in primary hyperaldosteronism is associated with a significantly increased risk of occurrence of cardiovascular events. The high plasma concentrations were also highlighted in the acute phase of myocardial infarction, or heart failure and are associated with an increase in major cardiovascular event rate, especially arrhythmias. In some experimental models of heart failure, it has been demonstrated a suppression of the occurrence of spontaneous FA by an anti-aldosterone treatment. The arrhythmogenic effect of aldosterone has also been shown in animal models. All these results indicate a potential role of aldosterone in the genesis of an arrhythmogenic substrate and the FA.

The hypothesis of this study is that aldosterone plasma levels in pre-reduced patients is predictive of recurrence risk of atrial fibrillation or other supraventricular tachycardias (flutter or atrial tachycardia) after FA reduction, either in using a radiofrequency ablation or via electrical cardioversion.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Aldosterone

• Study Type: Observational
• Enrollment (Anticipated): 170

Contacts and Locations

Study Locations

• France
  • Basse Normandie
    • Caen, Basse Normandie, France, 14000
      • Recruiting
      • Alexandre Joachim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population corresponds to all patients referred for atrial fibrillation cardioversion by radiofrequency ablation or electrical cardioversion, clinically stable, at Caen University Hospital, Pitié-Salpêtrière and Ambroise Paré clinic.

These patients have a strict, rigorous and systematic follow after these cardioversion at 1, 3 and 6 months with routine ECG.

Description

Inclusion Criteria:

• Patients referred for atrial fibrillation cardioversion by radiofrequency ablation or electrical cardioversion
• scheduled hospitalisation or hospitalisation unrelated to cardiovascular events
• Age at least 18 years
• Clinically Stable (see criteria for non-inclusion)

Exclusion Criteria:

• Patient unstable defined as any cardiovascular event that occurred in the previous 30 days

These events are:

• hospitalisation for cardiovascular causes
• appearance or worsening of symptoms consistent with cardiac failure

• appearance or worsening symptoms of coronary

  • Patient refusing participation in the study
  • Patient unable to provide follow-up visits

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
recurrence of supraventricular tachycardia (atrial fibrillation, atrial flutter and atrial tachycardia) after atrial fibrillation reduction by radiofrequency ablation or electrical cardioversion.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Find a correlation between recurrence of supraventricular tachycardia and plasmatic aldosterone level before cardioversion	6 months
Find a correlation between recurrence of supraventricular tachycardia and plasmatic ngal level before cardioversion	6 months
Find a correlation between recurrence of supraventricular tachycardia and plasmatic galectin-3 level before cardioversion	6 months
Find a correlation between recurrence of supraventricular tachycardia and occurrence of cardiovascular events	6 months
Find a correlation between recurrence of supraventricular tachycardia and occurrence of renal failure	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ANTICIPATED): September 1, 2017
• Study Completion (ANTICIPATED): November 1, 2017

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (ESTIMATE): June 17, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: atrial fibrillation; aldosterone; catheter ablation; galectin 3; ngal
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: A13-D37-VOL.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES