Study of Myocardial Interstitial Fibrosis in Hyperaldosteronism

Completed

• Conditions: Primary Hyperaldosteronism; Essential Hypertension; Secondary Hyperaldosteronism; Healthy
• Interventions: Other: non interventional study

• Registration Number: NCT02938910
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-11
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2015-12-15
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-17
• Last Update Submitted: 2016-10-17
• Study First Posted: 2016-10-19
• Last Update Posted: 2016-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	non interventional study	Healthy volunteers with normal blood pressure
Primary Hyperaldosteronism	non interventional study	Subjects with hypertension and high levels of seric aldosterone.
Essential Hypertension	non interventional study	Patient with hypertension without secondary cause of hypertension
Secondary Hyperaldosteronism	non interventional study	Patient with Gitelman syndrome, with normal blood pressure and high level of aldosterone

Primary Outcome Measures

Name	Time	Method
Interstitial fibrosis assessed by MRI	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

Name	Time	Method
Effect of hypertension on myocardial fibrosis assessed by MRI	One visit	Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between the degree of myocardial fibrosis
Effect of aldosteronism on myocardial fibrosis assessed by MRI	One visit	Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between the degree of myocardial fibrosis
Effect of aldosteronism on LV diastolic dysfunction	One visit	Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between the degree of LV diastolic dysfunction
Effect of aldosteronism on the relationship between circulating biomarkers of fibrosis	One visit	Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between circulating biomarkers of fibrosis
Evaluation of myocardial remodeling by MRI	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)
Effect of hypertension on LV diastolic dysfunction	One visit	Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between the degree of LV diastolic dysfunction
Effect of hypertension on the relationship between circulating biomarkers of fibrosis	One visit	Analyze the relationship in each of the two clinical situations (HTA or absence of hypertension) between circulating biomarkers of fibrosis

Trial Locations

Locations (1)

Centre d\'investigation Clinique, hopital Europeen George Pompidou; 🇫🇷 Paris, France