Understanding how genetics affect blood pressure response to salt intake
Role of Genetic Determinants in the Response to Acute Saline Load Testing in Patients With Essential Hypertension (Naload)
Ospedale San Raffaele · NCT04625569
This study is testing how genetics affect blood pressure changes in people with high blood pressure when they consume salt.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ospedale San Raffaele (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT04625569 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enroll 150 patients with hypertension to investigate their genetic response to an acute saline load test. Participants will undergo a controlled intravenous infusion of saline while their blood pressure is monitored and biological samples are collected for biochemical and genetic analysis. The study seeks to characterize the relationship between genetic predisposition and blood pressure response to salt, contributing to a larger database of previous research on this topic.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 to 65 with hypertension and specific criteria regarding sodium intake and body mass index.
Not a fit: Patients with secondary hypertension, severe hypertension, or those with a history of significant cardiovascular or metabolic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies for hypertension based on genetic profiles.
How similar studies have performed: Previous studies have explored genetic factors in hypertension, but this specific approach to acute saline response is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan
- IRCCS Ospedale San Raffaele — Milan, Italy (RECRUITING)
Study contacts
- Principal investigator: Chiara Lanzani, Doctor — Ospedale San Raffaele
- Study coordinator: Chiara Lanzani, doctor
- Email: lanzani.chiara@hsr.it
- Phone: 0206433891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension,Essential, Salt, Excess, Genetic Hypertension, Genetic Predisposition to Disease, hypertension, salt sensitivity, genetic