Study of Myocardial Interstitial Fibrosis in Hyperaldosteronism

NCT02938910 | Completed

• 1 other identifier: P110912
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Hyperaldosteronism; Secondary Hyperaldosteronism; Essential Hypertension; Healthy

Keywords

Primary hyperaldosteronism; Secondary hyperaldosteronism; Cardiac fibrosis; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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)

  One visit

Secondary Outcomes (7)

• Evaluation of myocardial remodeling by MRI

  One visit

• Effect of hypertension on myocardial fibrosis assessed by MRI

  One visit

• Effect of aldosteronism on myocardial fibrosis assessed by MRI

  One visit

• Effect of hypertension on LV diastolic dysfunction

  One visit

• Effect of aldosteronism on LV diastolic dysfunction

  One visit

Study Arms (4)

Healthy Volunteers

Healthy volunteers with normal blood pressure

Other: non interventional study

Primary Hyperaldosteronism

Subjects with hypertension and high levels of seric aldosterone.

Other: non interventional study

Secondary Hyperaldosteronism

Patient with Gitelman syndrome, with normal blood pressure and high level of aldosterone

Other: non interventional study

Essential Hypertension

Patient with hypertension without secondary cause of hypertension

Other: non interventional study

Interventions

non interventional study OTHER

Non invasive imaging study without interventional procedures

Essential Hypertension; Healthy Volunteers; Primary Hyperaldosteronism; Secondary Hyperaldosteronism

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Centre d\'investigation Clinique, hopital Europeen George Pompidou

Paris, 75015, France

Location

Related Publications (1)

• 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.

  PMID: 32950448 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urines and plasma

MeSH Terms

Conditions

Hyperaldosteronism; Essential Hypertension

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elie MOUSSEAUX, MD, PhD

  Assistance publique des hopitaux de Paris

  STUDY DIRECTOR

• Alban REDHEUIL, MD,PhD

  Assistance publique des hopitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: October 19, 2016
• Study Start: November 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

FR (1)