Genetic of Response to Acute Saline Load Test in Hypertension (Naload) (NCT04625569) | Clinical Trial Compass
UnknownNot Applicable
Genetic of Response to Acute Saline Load Test in Hypertension (Naload)
Italy150 participantsStarted 2019-07-08
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is looking at how genetics might affect the way my blood pressure responds to a salt load test — does my personal or family history of high blood pressure suggest that understanding my salt sensitivity could actually change how my hypertension is managed?
2The trial involves an 'acute saline load test,' which means receiving a saltwater infusion — what does that procedure involve, how long does it take, and are there any risks I should know about before considering it?
3Since this trial is listed as phase 'NA' and seems to be a genetic and physiological research study rather than a treatment trial, is there any direct benefit to me as a participant, or would I mainly be contributing to scientific knowledge about salt-sensitive hypertension?
4The recruitment status for this study is listed as 'unknown' — can you help me find out whether this trial is still actively enrolling patients, and if not, are there similar studies on salt sensitivity or genetic factors in hypertension that might be worth exploring?
5Given that this trial measures blood pressure changes after a salt load rather than testing a new medication, would participating in it complement or delay any standard treatment options you might already be recommending for my blood pressure?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.