Primary HyperaldosteronismCOEURALDONCT02938910
Study of Myocardial Interstitial Fibrosis in Hyperaldosteronism
An observational study of Primary Hyperaldosteronism and Secondary Hyperaldosteronism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Animal models have demonstrated the role of aldosterone in left ventricular remodeling involving fibrosis, apoptosis and hypertrophy. Myocardial fibrosis is a risk factor for serious arrhythmia and sudden death in ischemic and idiopathic hypertrophic heart disease. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Hyperaldosteronism, Secondary Hyperaldosteronism, Essential Hypertension
- What is being tested?
- non interventional study
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Oct 2014
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with primary or secondary hyperaldosteronism compared to hypertensive or normotensive controls
- Patients with primary hyperaldosteronism:
- Aldosterone / renin plasma ratio SUP 64 pmol / mU
- aldosterone in a semi-sitting position SUP 500pmol / l or an aldosteronuria> 63nmol/24h,
- Both under neutral treatment for at least 15 days (alpha-blocker, calcium channel blockers, central inhibitors). BMI = 35 kg / m².
- For patients with secondary hyperaldosteronism :
- Documented diagnosis by the detection of mutation (s) homozygous or compound heterozygous for the gene SLC12A3 encoding CLCNKB chloride channel, or the gene encoding the HTSC Na-Cl cotransport thiazide sensitive.
- Normal blood pressure (mean of three consecutive measurements of SBP INF 140 mmHg and DBP INF 90 mmHg measured in a semi-sitting position after 5 minutes of rest).
- For hypertensive patients :
- Hypertension diagnosed on an average of three consecutive BP measurements = 140 and / or = 90 mmHg in the supine position after 5 minutes of rest or average daytime PA SUP 135/85 mmHg in ambulatory blood pressure monitoring (ABPM) in self-measurement , the presence of one or more antihypertensive medications regardless of the BP level.
- No argument for secondary hypertension (renal artery stenosis, hypermineralocorticoidism, pheochromocytoma, iatrogenic ...) or negative balance of secondary hypertension.
- BMI < 35 kg/m2.
- For healthy subjects :
- Normal blood pressure (mean of three consecutive measurements of SBP INF 140 mmHg and DBP INF 90 mmHg measured in a semi-sitting position after 5 minutes of rest).
- Absence of HA known or detected on determinations carried out during the study (see criteria for PAHs).
- BMI <35 kg / m²
- Laboratory tests (hematological and biochemical blood tests, urinalysis, serology and Research toxic) within normal limits or clinically acceptable for age and sex.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d\'investigation Clinique, hopital Europeen George Pompidou
Paris, 75015
About this study
Official title: Study of Myocardial Interstitial Fibrosis in Hyperaldosteronism Noninvasive Comparative Study in Humans of the Respective Cardiovascular Effects of Hyperaldosteronism and Hypertension by Magnetic Resonance Imaging
Animal models have demonstrated the role of aldosterone in left ventricular remodeling involving fibrosis, apoptosis and hypertrophy. Myocardial fibrosis is a risk factor for serious arrhythmia and sudden death in ischemic and idiopathic hypertrophic heart disease. It is accepted that patients with primary aldosteronism have a higher prevalence of LV hypertrophy , arterial involvement and increased cardiovascular risk. In humans, a link has been demonstrated between aldosterone and heart failure as well as the benefit of the administration of an anti -aldosterone drug to lower mortality in this population , regardless of blood pressure level . The administration of spironolactone ( aldosterone ) in hypertensive rats has prevented the occurrence of aortic fibrosis . Plasma aldosteronism in humans has been associated with inflammation, fibrosis and aortic stiffness . However, primary aldosteronism is generally associated with so-called secondary hypertension . Chronic hypertension alone is a recognized etiological factor of myocardial hypertrophy ( myocardial fibrosis very advanced ) . The purpose of this study is to investigate the effects of MRI hyperaldosteronism on the heart.
Read the detailed description
Cross-sectional study with double analysis (A and B) with 2 x 2 sub-groups (ratio control/case 1/1)
- clinical situation: subjects are hypertensive. 20 subjects with primary aldosteronism will be compared to 20 patients with essential arterial hypertension
- clinical situation are normotensive subjects, 20 subjects with secondary aldosteronism loss in congenital salt (Bartter's syndrome / Gitelman) will be compared to 20 healthy volunteers. Controls (essential hypertension and healthy volunteers) are matched for age, sex and body size in two experimental groups (HAP and Gitelman). All subjects were recruited by the CIC of the European Georges Pompidou Hospital (Paris).
- Being tested
- non interventional study
- Keywords
- Primary hyperaldosteronism, Secondary hyperaldosteronism, Cardiac fibrosis, magnetic resonance imaging
- Medical subject headings
- Hyperaldosteronism, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non interventional studyOther
Non invasive imaging study without interventional procedures
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy volunteers with normal blood pressure Receives: Other: non interventional study | |
| Primary Hyperaldosteronism | Subjects with hypertension and high levels of seric aldosterone. Receives: Other: non interventional study | |
| Secondary Hyperaldosteronism | Patient with Gitelman syndrome, with normal blood pressure and high level of aldosterone Receives: Other: non interventional study | |
| Essential Hypertension | Patient with hypertension without secondary cause of hypertension Receives: Other: non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial fibrosis assessed by MRI
Quantitative interstitial fibrosis indices (intra- and extra-cellular LV mass) derived from myocardial relaxation time T1 MRI will be estimated in 4 populations with and without hypertension (patients with essential hypertension or with primary hyperaldosteronism versus healthy volunteers or patients with Gitelman syndrome), and with and without high level of aldosterone (patients with primary hyperaldosteronism or Gitelman syndrome versus patients with essential hypertension or healthy volunteers)
Measured: One visit
Secondary outcomes (7)
Evaluation of myocardial remodeling by MRI
Quantitative left ventricular remodeling (LV Mass and LV mass/end diastolic volume) will be estimated in 4 populations with and without hypertension (patients with essential hypertension or with primary hyperaldosteronism versus healthy volunteers or patients with Gitelman syndrome), and with and without high level of aldosterone (patients with primary hyperaldosteronism or Gitelman syndrome versus patients with essential hypertension or healthy volunteers)
Measured: One visit
Effect of hypertension on myocardial fibrosis assessed by MRI
Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between the degree of myocardial fibrosis
Measured: One visit
Effect of aldosteronism on myocardial fibrosis assessed by MRI
Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between the degree of myocardial fibrosis
Measured: One visit
Effect of hypertension on LV diastolic dysfunction
Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between the degree of LV diastolic dysfunction
Measured: One visit
Effect of aldosteronism on LV diastolic dysfunction
Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between the degree of LV diastolic dysfunction
Measured: One visit
Effect of hypertension on the relationship between circulating biomarkers of fibrosis
Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between circulating biomarkers of fibrosis
Measured: One visit
Effect of aldosteronism on the relationship between circulating biomarkers of fibrosis
Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between circulating biomarkers of fibrosis
Measured: One visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startNov 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary HyperaldosteronismStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elie MOUSSEAUX, MD, PhD, Study director, Assistance publique des hopitaux de ParisAlban REDHEUIL, MD,PhD, Study director, Assistance publique des hopitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938910
- Sponsor's protocol ID
- P110912
- Acronym
- COEURALDO
- Status last verified
- Oct 2016
- First submitted
- 15 Dec 2015
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Redheuil A, Blanchard A, Pereira H, Raissouni Z, Lorthioir A, Soulat G, Vargas-Poussou R, Amar L, Paul JL, Helley D, Azizi M, Kachenoura N, Mousseaux E. Aldosterone-Related Myocardial Extracellular Matrix Expansion in Hypertension in Humans: A Proof-of-Concept Study by Cardiac Magnetic Resonance. JACC Cardiovasc Imaging. 2020 Oct;13(10):2149-2159. doi: 10.1016/j.jcmg.2020.06.026. Epub 2020 Sep 16.
PubMed 32950448
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Myocardial Interstitial Fibrosis in Hyperaldosteronism Noninvasive Comparative Study in Humans of the Respective Cardiovascular Effects of Hyperaldosteronism and Hypertension by Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02938910
- Acronym / sponsor ID
- COEURALDO / P110912
- Keywords
- Primary hyperaldosteronism, Secondary hyperaldosteronism, Cardiac fibrosis, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Oct 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.
Animal models have demonstrated the role of aldosterone in left ventricular remodeling involving fibrosis, apoptosis and hypertrophy. Myocardial fibrosis is a risk factor for serious arrhythmia and sudden death in ischemic and idiopathic hypertrophic heart disease. It is accepted that patients with primary aldosteronism have a higher prevalence of LV hypertrophy , arterial involvement and increased cardiovascular risk. In humans, a link has been demonstrated between aldosterone and heart failure as well as the benefit of the administration of an anti -aldosterone drug to lower mortality in this population , regardless of blood pressure level . The administration of spironolactone ( aldosterone ) in hypertensive rats has prevented the occurrence of aortic fibrosis . Plasma aldosteronism in humans has been associated with inflammation, fibrosis and aortic stiffness . However, primary aldosteronism is generally associated with so-called secondary hypertension . Chronic hypertension alone is a recognized etiological factor of myocardial hypertrophy ( myocardial fibrosis very advanced ) . The purpose of this study is to investigate the effects of MRI hyperaldosteronism on the heart.
Detailed description
Cross-sectional study with double analysis (A and B) with 2 x 2 sub-groups (ratio control/case 1/1)
- clinical situation: subjects are hypertensive. 20 subjects with primary aldosteronism will be compared to 20 patients with essential arterial hypertension
- clinical situation are normotensive subjects, 20 subjects with secondary aldosteronism loss in congenital salt (Bartter's syndrome / Gitelman) will be compared to 20 healthy volunteers. Controls (essential hypertension and healthy volunteers) are matched for age, sex and body size in two experimental groups (HAP and Gitelman). All subjects were recruited by the CIC of the European Georges Pompidou Hospital (Paris).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: non interventional studyHealthy volunteers with normal blood pressure |
| Primary Hyperaldosteronism | – | Other: non interventional studySubjects with hypertension and high levels of seric aldosterone. |
| Secondary Hyperaldosteronism | – | Other: non interventional studyPatient with Gitelman syndrome, with normal blood pressure and high level of aldosterone |
| Essential Hypertension | – | Other: non interventional studyPatient with hypertension without secondary cause of hypertension |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary or secondary hyperaldosteronism compared to hypertensive or normotensive controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non interventional studyNon invasive imaging study without interventional procedures | Other | Essential Hypertension, Healthy Volunteers, Primary Hyperaldosteronism, Secondary Hyperaldosteronism |
Primary outcome
Interstitial fibrosis assessed by MRI
Time frame: One visit
Quantitative interstitial fibrosis indices (intra- and extra-cellular LV mass) derived from myocardial relaxation time T1 MRI will be estimated in 4 populations with and without hypertension (patients with essential hypertension or with primary hyperaldosteronism versus healthy volunteers or patients with Gitelman syndrome), and with and without high level of aldosterone (patients with primary hyperaldosteronism or Gitelman syndrome versus patients with essential hypertension or healthy volunteers)
7 secondary outcomes
Evaluation of myocardial remodeling by MRI
Time frame: One visit
Effect of hypertension on myocardial fibrosis assessed by MRI
Time frame: One visit
Effect of aldosteronism on myocardial fibrosis assessed by MRI
Time frame: One visit
Effect of hypertension on LV diastolic dysfunction
Time frame: One visit
Effect of aldosteronism on LV diastolic dysfunction
Time frame: One visit
Effect of hypertension on the relationship between circulating biomarkers of fibrosis
Time frame: One visit
Effect of aldosteronism on the relationship between circulating biomarkers of fibrosis
Time frame: One visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Derived from this study: PubMed 32950448Redheuil A, Blanchard A, Pereira H, Raissouni Z, Lorthioir A, Soulat G, Vargas-Poussou R, Amar L, Paul JL, Helley D, Azizi M, Kachenoura N, Mousseaux E. Aldosterone-Related Myocardial Extracellular Matrix Expansion in Hypertension in Humans: A Proof-of-Concept Study by Cardiac Magnetic Resonance. JACC Cardiovasc Imaging. 2020 Oct;13(10):2149-2159. doi: 10.1016/j.jcmg.2020.06.026. Epub 2020 Sep 16.
Related trials for Primary Hyperaldosteronism
Not yet recruitingPhase 2
SYH2072 Tablets in Participants With Primary Aldosteronism
Primary Aldosteronism
Recruiting
Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)
Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Active, not recruiting
Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA
Primary Aldosteronism
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.
Elie MOUSSEAUX, MD, PhD study director
Assistance publique des hopitaux de Paris
Alban REDHEUIL, MD,PhD study director
Assistance publique des hopitaux de Paris
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 Primary Hyperaldosteronism and Secondary Hyperaldosteronism, run by Assistance Publique - Hôpitaux de Paris 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?
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: finished, as of the sponsor's last update on 19 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interstitial fibrosis assessed by MRI (time frame: One visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02938910, which also lists 1 linked publication.
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 19 Oct 2016.