Hypertension,EssentialNaloadNCT04625569
Genetic of Response to Acute Saline Load Test in Hypertension (Naload)
An observational study of Hypertension,Essential and Salt; Excess, run by Ospedale San Raffaele at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension,Essential, Salt; Excess, Genetic Hypertension
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jul 2019to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We enrolled newly discovered, never treated, mild hypertensive male patients in the 'Outpatient Clinic for Hypertension' of San Raffaele Hospital, Milan (Italy)
Who may be able to join
- 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.
Who cannot join
- Female patients
- history of myocardial infarction,
- stroke,
- congestive heart failure,
- liver disease, secondary cause of hypertension,
- diabetes,
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, 20132
Chiara Lanzani, MD, +390226433891, lanzani.chiara@hsr.it
About this study
Official title: Role of Genetic Determinants in the Response to Acute Saline Load Testing in Patients With Essential Hypertension (Naload)
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.
Read the 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)
- Conditions
- Hypertension,Essential, Salt; Excess, Genetic Hypertension, Genetic Predisposition to Disease
- Keywords
- hypertension, salt sensitivity, genetic
- Medical subject headings
- Essential Hypertension, Genetic Predisposition to Disease, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
DMBP120
Blood pressure variation at the end of infusion
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start8 Jul 2019
- Primary completion8 Jul 2023
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Lanzani, Ospedale San Raffaele
- Investigators
- Chiara Lanzani, Doctor, Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625569
- Sponsor's protocol ID
- Naload
- Acronym
- Naload
- Status last verified
- May 2024
- First submitted
- 6 Nov 2020
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24185693Citterio 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.
PubMed 31992575Lanzani 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.
PubMed 26667413Citterio 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.
PubMed 24060892
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Genetic Determinants in the Response to Acute Saline Load Testing in Patients With Essential Hypertension (Naload)
- ClinicalTrials.gov ID
- NCT04625569
- Acronym / sponsor ID
- Naload / Naload
- Conditions
- Hypertension,Essential, Salt; Excess, Genetic Hypertension, Genetic Predisposition to Disease
- Keywords
- hypertension, salt sensitivity, genetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 8 Jul 2023 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We enrolled newly discovered, never treated, mild hypertensive male patients in the 'Outpatient Clinic for Hypertension' of San Raffaele Hospital, Milan (Italy)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- Female patients
- history of myocardial infarction,
- stroke,
- congestive heart failure,
- liver disease, secondary cause of hypertension,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DMBP120
Time frame: 120 min
Blood pressure variation at the end of infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 24185693Trudu 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.
- Background: PubMed 31992575Citterio 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.
- Background: PubMed 26667413Lanzani 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.
- Background: PubMed 24060892Citterio 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara Lanzani, Doctor principal investigator
Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension,Essential and Salt; Excess, run by Ospedale San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chiara Lanzani, doctor (0206433891, lanzani.chiara@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DMBP120 (time frame: 120 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04625569, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.