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

Atrial Fibrillation Clinical Trial

— ALDO-AF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02804321
• Other study ID #: A13-D37-VOL.18
• Status: Recruiting
• Phase: N/A
• First received: June 15, 2016
• Last updated: June 16, 2016
• Start date: September 2013
• Est. completion date: November 2017

Study information

• Verified date: June 2016
• Source: University Hospital, Caen
• Contact: Joachim Alexandre, MD
• Email: alexandre-j[@]chu-caen.fr
• Is FDA regulated: No
• Health authority: France: ANSM - French Health Products Safety Agency
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: November 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aldosterone
• Atrial Fibrillation

Locations

Country	Name	City	State
France	Alexandre Joachim	Caen	Basse Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of supraventricular tachycardia (atrial fibrillation, atrial flutter and atrial tachycardia) after atrial fibrillation reduction by radiofrequency ablation or electrical cardioversion.		6 months	No
Secondary	Find a correlation between recurrence of supraventricular tachycardia and plasmatic aldosterone level before cardioversion		6 months	No
Secondary	Find a correlation between recurrence of supraventricular tachycardia and plasmatic ngal level before cardioversion		6 months	No
Secondary	Find a correlation between recurrence of supraventricular tachycardia and plasmatic galectin-3 level before cardioversion		6 months	No
Secondary	Find a correlation between recurrence of supraventricular tachycardia and occurrence of cardiovascular events		6 months	No
Secondary	Find a correlation between recurrence of supraventricular tachycardia and occurrence of renal failure		6 months	No