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

Role of Genetic Determinants in the Response to Acute Saline Load Testing in Patients With Essential Hypertension (Naload)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04625569

Acronym

Naload

Enrollment

150

Registered

2020-11-12

Start date

2019-07-08

Completion date

2025-09-30

Last updated

2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

hypertension, salt sensitivity, genetic

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.

Detailed description

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)

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
DMBP120	120 min	Blood pressure variation at the end of infusion

Countries

Italy

Contacts

Primary ContactChiara Lanzani, doctor

lanzani.chiara@hsr.it0206433891

Backup ContactCinzia Scotti, secretary

scotti.cinzia@hsr.it0226435330

Outcome results