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Study of Myocardial Interstitial Fibrosis in Hyperaldosteronism (COEURALDO)

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ClinicalTrials.gov Identifier: NCT02938910
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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. 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.

Condition or disease Intervention/treatment
Primary Hyperaldosteronism Secondary Hyperaldosteronism Essential Hypertension Healthy Other: non interventional study

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).

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
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
Study Start Date : November 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy Volunteers
Healthy volunteers with normal blood pressure
Other: non interventional study
Non invasive imaging study without interventional procedures

Primary Hyperaldosteronism
Subjects with hypertension and high levels of seric aldosterone.
Other: non interventional study
Non invasive imaging study without interventional procedures

Secondary Hyperaldosteronism
Patient with Gitelman syndrome, with normal blood pressure and high level of aldosterone
Other: non interventional study
Non invasive imaging study without interventional procedures

Essential Hypertension
Patient with hypertension without secondary cause of hypertension
Other: non interventional study
Non invasive imaging study without interventional procedures




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Evaluation of myocardial remodeling by MRI [ Time Frame: One visit ]
    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)

  2. Effect of hypertension on myocardial fibrosis assessed by MRI [ Time Frame: One visit ]
    Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between the degree of myocardial fibrosis

  3. Effect of aldosteronism on myocardial fibrosis assessed by MRI [ Time Frame: One visit ]
    Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between the degree of myocardial fibrosis

  4. Effect of hypertension on LV diastolic dysfunction [ Time Frame: One visit ]
    Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between the degree of LV diastolic dysfunction

  5. Effect of aldosteronism on LV diastolic dysfunction [ Time Frame: One visit ]
    Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between the degree of LV diastolic dysfunction

  6. Effect of hypertension on the relationship between circulating biomarkers of fibrosis [ Time Frame: One visit ]
    Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between circulating biomarkers of fibrosis

  7. Effect of aldosteronism on the relationship between circulating biomarkers of fibrosis [ Time Frame: One visit ]
    Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between circulating biomarkers of fibrosis


Biospecimen Retention:   Samples Without DNA
Urines and plasma


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary or secondary hyperaldosteronism compared to hypertensive or normotensive controls
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938910


Locations
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France
Centre d\'investigation Clinique, hopital Europeen George Pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Director: Elie MOUSSEAUX, MD, PhD Assistance publique des hopitaux de Paris
Study Director: Alban REDHEUIL, MD,PhD Assistance publique des hopitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02938910     History of Changes
Other Study ID Numbers: P110912
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Primary hyperaldosteronism
Secondary hyperaldosteronism
Cardiac fibrosis
magnetic resonance imaging
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Hyperaldosteronism
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases