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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804321
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : June 17, 2016
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Tracking Information
First Submitted Date June 15, 2016
First Posted Date June 17, 2016
Last Update Posted Date June 17, 2016
Study Start Date September 2013
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2016)
recurrence of supraventricular tachycardia (atrial fibrillation, atrial flutter and atrial tachycardia) after atrial fibrillation reduction by radiofrequency ablation or electrical cardioversion. [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 16, 2016)
  • Find a correlation between recurrence of supraventricular tachycardia and plasmatic aldosterone level before cardioversion [ Time Frame: 6 months ]
  • Find a correlation between recurrence of supraventricular tachycardia and plasmatic ngal level before cardioversion [ Time Frame: 6 months ]
  • Find a correlation between recurrence of supraventricular tachycardia and plasmatic galectin-3 level before cardioversion [ Time Frame: 6 months ]
  • Find a correlation between recurrence of supraventricular tachycardia and occurrence of cardiovascular events [ Time Frame: 6 months ]
  • Find a correlation between recurrence of supraventricular tachycardia and occurrence of renal failure [ Time Frame: 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Plasma Aldosterone Levels and Atrial Fibrillation Reduction (ALDO-AF Study)
Official Title Plasma Aldosterone Levels and Atrial Fibrillation Reduction (ALDO-AF Study)
Brief 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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Retention:   Samples Without DNA
Description:
aldosterone galectine 3 ngal
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.

Condition
  • Atrial Fibrillation
  • Aldosterone
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 16, 2016)
170
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02804321
Other Study ID Numbers A13-D37-VOL.18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party University Hospital, Caen
Study Sponsor University Hospital, Caen
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Caen
Verification Date June 2016