From Micro- to Macro-vessels : Water, Salt, Heart and Kidneys

NCT05114291 | Completed

• 2 other identifiers: APHP2109342021-A01291-40
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension is a public health concern and affects nearly a third of the French population. It can be complicated by visceral impact (including brain, heart and kidney complications) as well as on vessels especially large arteries, responsible for arterial stiffening. There are close interactions between heart and kidneys, as well as between large arteries and micro-vessels. These relationships also involve the water and salt balance and its regulatory mechanisms. Urinary concentration abilities are closely linked to the renal medullary blood flow, which in itself depends on the integrity of renal micro vessels, thus influencing the water and salt balance. Few previous studies evaluated the interconnections between renal urinary concentration abilities and blood pressure. A previous-one reported a positive relation between pulse pressure and urinary concentration in men, suggesting that subjects with higher urinary osmolarity could present a higher cardiovascular risk. Carotid-femoral pulse wave velocity represents the gold standard for non-invasive arterial stiffness assessment and constitutes an arteriosclerosis infra-clinical marker recommended by the European Society of Cardiology- European Society of Hypertension. It is considered as an independent predictor for global and cardiovascular mortality, coronary heart disease and fatal stroke among patients with hypertension, diabetes or end stage kidney disease. The purpose of this study is to evaluate the relations between fasting urinary osmolarity and arterial stiffness assessed by carotid-femoral pulse wave velocity (CF-PWV) among patients with hypertension.

Conditions

Hypertension

Keywords

Hypertension; Aortic stiffness; Fasting urinary osmolarity; Cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• CF-PWV

  Carotid-femoral pulse wave velocity

  Inclusion

Secondary Outcomes (5)

• PRA

  Inclusion

• Nocturnal dipping percentage of systolic blood pressure

  Inclusion

• Smoking status

  Inclusion

• Ankle-brachial pressure index (ABPI)

  Inclusion

• Primary hyperaldosteronism

  Inclusion

Interventions

Explorations are planned as part of the one-day hospitalization OTHER

* Clinical parameters : Interrogation, physical examination, morphological data measurements (weight, height, waist circumference, hip circumference) and impedencemetry (body composition). * Biological samples : Blood and urine exam, fasting urine sample (urinary osmolarity) * Standardized blood pressure measurement : * After 5 to 10 minutes of rest, with automated measurements at 1 minute intervals : "un-attended", then "attended" * Hemodynamic parameters : * Sphygmocor® : measure of the central blood pressure and pulse wave velocity * MESI® tool : measure of the Systolic Pressure Index (PSI or IPS) * pOpmetre® : Calculation of the speed of the pulse wave by the pOpmetre® device * Others : if indicated (echocardiography, ABPM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study concerns patients with hypertension who are addressed to a one-day hospitalization in order to realize standardized examinations (must include hormonal analyses : renin and aldosterone)

You may qualify if:

• Adults patients
• Day hospitalization for a check-up in the context of arterial hypertension with suspicion of secondary origin including a dosage of renin and plasma aldosterone
• Non-opposition to the study

You may not qualify if:

• Cardiac arrythmia
• Patient under AME (state medical assistance)
• Treatments interfering with uninterrupted hormonal dosages before day hospitalization
• Absence of B-blockers, converting enzyme inhibitor and sartans in the 15 days preceding the dosages
• Absence of antialdosterone, and amiloride in the 6 weeks preceding the dosages
• Absence of loop diuretics or diuretics in the 7 days preceding the dosages

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Centre Interdisciplinaire de Thérapeutique et d'Education APHP- Hôtel Dieu Hospital

Paris, IDF, 75004, France

Location

MeSH Terms

Conditions

Hypertension

Interventions

Hospitalization

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lynda CHEDDANI, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 9, 2021
• Study Start: December 10, 2021
• Primary Completion: June 7, 2023
• Study Completion: July 7, 2023
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)