Genetic of Response to Acute Saline Load Test in Hypertension (Naload)

NCT ID: NCT04625569

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-08

Study Completion Date

2025-09-30

Brief Summary

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NHP referred to our outpatient clinic will be enrolled (150 newly recruited) in acute saline test for phenotype characterisation of PNat relationship(7). For each patient we will collect urine and blood samples for standard clinical biochemistry, including electrolytes, creatinine, EO, aldosterone, plasma renin activity, urinary uromodulin (ELISA), urinary and serum uric acid and blood samples for genetic test.

Detailed Description

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Acute salt load test: after the equilibration period and achievement of a steady state, a constant-rate i.v. infusion of 2 L of 0.9% NaCl was carried out in 2 hours. BP (mean of 3 measurements taken 3 minutes apart) was measured every 30 minutes during the 2 hours of loading and 3 times at 3-min intervals at the end of the infusion. These last 3 BP values were averaged and used in the analysis.

The results of these tests will be added to an already collected database of salt load test collected in the previous studies (already published)

Conditions

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Hypertension,Essential Salt; Excess Genetic Hypertension Genetic Predisposition to Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* age 18 to 65years;
* body mass index (BMI) \<30 kg/m2;
* Na intake, evaluated as urinary Na excretion of \<300 mEq/24 hours; .office systolic BP (SBP) \>140 mm Hg and diastolic BP (DBP) \>90 mm Hg in 3 consecutive visits to their family doctors.

Exclusion Criteria

* Female patients
* history of myocardial infarction,
* stroke,
* congestive heart failure,
* liver disease, secondary cause of hypertension,
* diabetes,
* severe hypertension (\>160/110 mm Hg),
* abuse of drugs or alcohol, .creatinine clearance \< 80 mL/m.

Secondary forms of hypertension (e.g. primary aldosteronism) were ruled out with specific investigations when deemed appropriate
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Chiara Lanzani

Medical doctor in nephrology unit, nephrologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chiara Lanzani, Doctor

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Raffaele

Locations

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IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Chiara Lanzani, doctor

Role: CONTACT

0206433891

Cinzia Scotti, secretary

Role: CONTACT

0226435330

Facility Contacts

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Chiara Lanzani, MD

Role: primary

+390226433891

References

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Trudu M, Janas S, Lanzani C, Debaix H, Schaeffer C, Ikehata M, Citterio L, Demaretz S, Trevisani F, Ristagno G, Glaudemans B, Laghmani K, Dell'Antonio G; SKIPOGH team; Loffing J, Rastaldi MP, Manunta P, Devuyst O, Rampoldi L. Common noncoding UMOD gene variants induce salt-sensitive hypertension and kidney damage by increasing uromodulin expression. Nat Med. 2013 Dec;19(12):1655-60. doi: 10.1038/nm.3384. Epub 2013 Nov 3.

Reference Type BACKGROUND
PMID: 24185693 (View on PubMed)

Citterio L, Delli Carpini S, Lupoli S, Brioni E, Simonini M, Fontana S, Zagato L, Messaggio E, Barlassina C, Cusi D, Manunta P, Lanzani C. Klotho Gene in Human Salt-Sensitive Hypertension. Clin J Am Soc Nephrol. 2020 Mar 6;15(3):375-383. doi: 10.2215/CJN.08620719. Epub 2020 Jan 28.

Reference Type BACKGROUND
PMID: 31992575 (View on PubMed)

Lanzani C, Gatti G, Citterio L, Messaggio E, Delli Carpini S, Simonini M, Casamassima N, Zagato L, Brioni E, Hamlyn JM, Manunta P. Lanosterol Synthase Gene Polymorphisms and Changes in Endogenous Ouabain in the Response to Low Sodium Intake. Hypertension. 2016 Feb;67(2):342-8. doi: 10.1161/HYPERTENSIONAHA.115.06415. Epub 2015 Dec 14.

Reference Type BACKGROUND
PMID: 26667413 (View on PubMed)

Citterio L, Ferrandi M, Delli Carpini S, Simonini M, Kuznetsova T, Molinari I, Dell' Antonio G, Lanzani C, Merlino L, Brioni E, Staessen JA, Bianchi G, Manunta P. cGMP-dependent protein kinase 1 polymorphisms underlie renal sodium handling impairment. Hypertension. 2013 Dec;62(6):1027-33. doi: 10.1161/HYPERTENSIONAHA.113.01628. Epub 2013 Sep 23.

Reference Type BACKGROUND
PMID: 24060892 (View on PubMed)

Other Identifiers

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Naload

Identifier Type: -

Identifier Source: org_study_id

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