NCT04625569

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2023

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

4 years

First QC Date

November 6, 2020

Last Update Submit

May 11, 2024

Conditions

Hypertension,EssentialSalt; ExcessGenetic HypertensionGenetic Predisposition to Disease

Keywords

hypertensionsalt sensitivitygenetic

Outcome Measures

Primary Outcomes (1)

  • DMBP120

    Blood pressure variation at the end of infusion

    120 min

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We enrolled newly discovered, never treated, mild hypertensive male patients in the 'Outpatient Clinic for Hypertension' of San Raffaele Hospital, Milan (Italy)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 24185693BACKGROUND

  • 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.

    PMID: 31992575BACKGROUND

  • 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.

    PMID: 26667413BACKGROUND

  • 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.

    PMID: 24060892BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood and urinary sample

MeSH Terms

Conditions

Essential HypertensionGenetic Predisposition to DiseaseHypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chiara Lanzani, Doctor

    Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Lanzani, doctor

CONTACT

0206433891lanzani.chiara@hsr.it

Cinzia Scotti, secretary

CONTACT

0226435330scotti.cinzia@hsr.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor in nephrology unit, nephrologist

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 12, 2020

Study Start

July 8, 2019

Primary Completion

July 8, 2023

Study Completion

September 30, 2025

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations

IT(1)