Atrial FibrillationALDO-AFNCT02804321
Plasma Aldosterone Levels and Atrial Fibrillation Reduction (ALDO-AF Study)
An observational study of Atrial Fibrillation and Aldosterone, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Aldosterone
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Nov 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Joachim Alexandre, MD contact
France1 site, 1 recruiting
- Recruiting
Alexandre Joachim
Caen, Basse Normandie, 14000
Joachim Alexandre, MD, alexandre-j@chu-caen.fr
About this study
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.
Read more
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.
- Conditions
- Atrial Fibrillation, Aldosterone
- Keywords
- catheter ablation, galectin 3, ngal, aldosterone, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of supraventricular tachycardia (atrial fibrillation, atrial flutter and atrial tachycardia) after atrial fibrillation reduction by radiofrequency ablation or electrical cardioversion.
Measured: 6 months
Secondary outcomes (5)
Find a correlation between recurrence of supraventricular tachycardia and plasmatic aldosterone level before cardioversion
Measured: 6 months
Find a correlation between recurrence of supraventricular tachycardia and plasmatic ngal level before cardioversion
Measured: 6 months
Find a correlation between recurrence of supraventricular tachycardia and plasmatic galectin-3 level before cardioversion
Measured: 6 months
Find a correlation between recurrence of supraventricular tachycardia and occurrence of cardiovascular events
Measured: 6 months
Find a correlation between recurrence of supraventricular tachycardia and occurrence of renal failure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startSep 2013
- Primary completionSep 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804321
- Sponsor's protocol ID
- A13-D37-VOL.18
- Acronym
- ALDO-AF
- Status last verified
- Jun 2016
- First submitted
- 15 Jun 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Aldosterone Levels and Atrial Fibrillation Reduction (ALDO-AF Study)
- ClinicalTrials.gov ID
- NCT02804321
- Acronym / sponsor ID
- ALDO-AF / A13-D37-VOL.18
- Conditions
- Atrial Fibrillation, Aldosterone
- Keywords
- catheter ablation, galectin 3, ngal, aldosterone, atrial fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- Patient unstable defined as any cardiovascular event that occurred in the previous 30 days
- hospitalisation for cardiovascular causes
- appearance or worsening of symptoms consistent with cardiac failure
- appearance or worsening symptoms of coronary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Individual participant dataSharing planned: Yes
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Alexandre, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Aldosterone, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joachim Alexandre, MD (alexandre-j@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.