Hypertension in AdolescenceHYGEFNCT06049641
Hypertension in High School Students
An observational study of Hypertension in Adolescence and Adolescent Overweight, run by Ospedale San Raffaele at 1 site in Italy.
Trial summary
Hypertension and obesity in the young population are major risk factors for renal and cardiovascular events, which could arise in adulthood. A candidate-gene approach will be applied in a cohort observational study, in which investigators will collect data from high school adolescent students. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension in Adolescence, Adolescent Overweight
- How many people
- 2,638 participants
- Where
- 1 siteItaly
- Study dates
- 31 Oct 2014to 30 Oct 2018
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The final sample included 2638 white adolescents, 56% were females, 30% were from Milano (North Italy), 44% from Livorno (central Italy), and 26% from Grottaglie (South Italy).
Who may be able to join
- Age between 13 and 19 years old
- Caucasian
Who cannot join
- Age more than 19 years old
- Not Caucasian
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypertension in High School Students: Genetic and Environmental Factors
Hypertension and obesity in the young population are major risk factors for renal and cardiovascular events, which could arise in adulthood. A candidate-gene approach will be applied in a cohort observational study, in which investigators will collect data from high school adolescent students. Participants underwent anthropometric and blood pressure measurements, as well as saliva and urine sample collection for genomic DNA extraction and renal function evaluation, respectively. Candidate genes previously implicated in salt-sensitive hypertension in adults will be tested to verify impact on blood pressure (BP) also among adolescents. Since inflammatory mechanisms may be involved in pathophysiology of hypertension and in endothelial dysfunction and atherosclerosis through reactive oxygen species, the baseline urinary excretion of inflammatory and oxidative stress markers in a subgroup of adolescents stratified according to ADD1 (alpha adducin) rs4961 genotypes will be assessed.
Read the detailed description
Pediatric hypertension is associated with cardiovascular organ damage, which in turn may lead to cardiovascular disease (CVD) and acute events in adulthood.1 Over the past few decades, the prevalence of hypertension has progressively increased in children and adolescents, generating a significant public health issue and considerable amount of research. BP values among adolescents tend to be less heterogeneous than in adults, and the impact of genetic factors, even if small, may be the expression of pathogenic mechanisms that have been present since birth.
With this study, named HYGEF (Hypertension in high school students: Genetic and Environmental Factors), authors wanted to: 1. determine the prevalence of obesity and hypertension (HT) in a cohort of adolescents, 2. perform genetic analyses to determine a link between specific polymorphisms and/or mutations of genes involved in the development of HT in adults like the Adducin genes and Endogenous Ouabain (EO) and HT and 3. explore whether urine Na+/K+ excretion and urinary markers of inflammation and oxidative stress are linked to HT and cardiovascular risk in participants with the selected genotypes.
Adolescents will be enrolled for the study in high schools in the north (Milan), center (Livorno) and south (Grottaglie) of Italy, to obtain a sample that could be representative of the italian adolescents. During the visit at the high school investigators obtain questionnaires to have some information about eating habits, lifestyle and family history, two (or three in they were very discordant) blood pressure measurements, weight and height of the students, a sample of urine and a sample of saliva to extract DNA.
Genotyping: On the basis of our previous genetic studies carried out in adult patients with hypertension and cardiovascular and renal related diseases, 15 SNPs located in 13 candidate genes have been selected: rs1045642 in ABCB1, rs4343 in ACE (angiotensin converting enzyme), rs4961 in ADD1 (alpha-adducin), rs4984 in ADD2 (beta-adducin), rs3731566 in ADD3 (gamma-adducin), rs11638442 in CYP11A1 (cytochrome P450 family 11 subfamily A member 1), rs1799998 in CYP11B2 (aldosterone synthase), rs2236780, rs6203 and rs10923835 in HSD3B1 genetic region, rs9536314 in KL, rs2254524 in LSS, rs4149601 in neural precursor cell expressed, developmentally down-regulated 4-like, NEDD4L (E3 ubiquitin-protein ligase), PRKG1 (protein kinase, rs1904694 in cGMP-dependent, type I), rs4238595 in UMOD (uromodulin).
Analysis of Urines: Na+, K+, albumin, and creatinine were measured on a first fasting morning urine sample. The Kawasaki formula was used to estimate 24-hour urinary sodium (24h UNa) excretion expressed as mEq/24 h. In a subgroup a urine spot sample for each student will be immediately frozen for protein analysis. Investigators plan to measure simultaneously IL1β, IL6, IL10, IL12p70, TNF-α, MCP1 (monocyte chemoattractant protein), PTX3 (pentraxin-3) by ELISA test using LXSAHM Human Magnetic Luminex Screening Assay. Soluble α- Klotho, 8-Oxo-2'-deoxyguanosine will be measured by Elisa kit assay. Nitric oxide (NO) was measured by the colorimetric Nitric Oxide Assay kit. Advanced Oxidation Protein Products will be measured using the colorimetric OxiSelect Advanced Oxidation Protein Products Assay Kit.
- Conditions
- Hypertension in Adolescence, Adolescent Overweight
- Keywords
- hypertension, adolescence, obesity, genetic
- Medical subject headings
- Pediatric Obesity, Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 13 to 15 Year-Old | * Normotensive (Normal BP): SBP and/or DBP values below the 90th percentile for teens of the same age and sex. * Prehypertensive (High-normal BP): SBP and/or DBP values at or above the 90th percentile and/or below the 95th percentile for for teens of the same age and sex. * Hypertensive: SBP and/or DBP values at or above the 95th percentile for teens of the same age and sex. | |
| 16 to 19 Year-Old | * Normotensive (Normal BP): SBP <130 mmHg and/or DBP <85 mm Hg. * Prehypertensive (High-normal BP): SBP 130 to 139 mmHg and/or DBP 85 to 89 mm Hg. * Hypertensive: SBP ≥140 mm Hg and/or DBP ≥90 mmHg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim of the study was to establish a link of specific polymorphisms of Adducins and EO-related genes with selected phenotypes (hypertension, Na+ and K+ intake).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start31 Oct 2014
- Primary completion31 May 2017
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Hypertension in AdolescenceStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,638 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Lanzani, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049641
- Sponsor's protocol ID
- HYGEF STUDY
- Acronym
- HYGEF
- Status last verified
- May 2024
- First submitted
- 5 Sep 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Simone G, Devereux RB, Daniels SR, Koren MJ, Meyer RA, Laragh JH. Effect of growth on variability of left ventricular mass: assessment of allometric signals in adults and children and their capacity to predict cardiovascular risk. J Am Coll Cardiol. 1995 Apr;25(5):1056-62. doi: 10.1016/0735-1097(94)00540-7.
PubMed 7897116Lurbe E, Agabiti-Rosei E, Cruickshank JK, Dominiczak A, Erdine S, Hirth A, Invitti C, Litwin M, Mancia G, Pall D, Rascher W, Redon J, Schaefer F, Seeman T, Sinha M, Stabouli S, Webb NJ, Wuhl E, Zanchetti A. 2016 European Society of Hypertension guidelines for the management of high blood pressure in children and adolescents. J Hypertens. 2016 Oct;34(10):1887-920. doi: 10.1097/HJH.0000000000001039.
PubMed 27467768National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004 Aug;114(2 Suppl 4th Report):555-76. No abstract available.
PubMed 15286277Intersalt: an international study of electrolyte excretion and blood pressure. Results for 24 hour urinary sodium and potassium excretion. Intersalt Cooperative Research Group. BMJ. 1988 Jul 30;297(6644):319-28. doi: 10.1136/bmj.297.6644.319.
PubMed 3416162Citterio L, Lanzani C, Manunta P, Bianchi G. Genetics of primary hypertension: the clinical impact of adducin polymorphisms. Biochim Biophys Acta. 2010 Dec;1802(12):1285-98. doi: 10.1016/j.bbadis.2010.03.014. Epub 2010 Apr 8.
PubMed 20382219Efendiev R, Krmar RT, Ogimoto G, Zwiller J, Tripodi G, Katz AI, Bianchi G, Pedemonte CH, Bertorello AM. Hypertension-linked mutation in the adducin alpha-subunit leads to higher AP2-mu2 phosphorylation and impaired Na+,K+-ATPase trafficking in response to GPCR signals and intracellular sodium. Circ Res. 2004 Nov 26;95(11):1100-8. doi: 10.1161/01.RES.0000149570.20845.89. Epub 2004 Nov 4.
PubMed 15528469Manunta P, Maillard M, Tantardini C, Simonini M, Lanzani C, Citterio L, Stella P, Casamassima N, Burnier M, Hamlyn JM, Bianchi G. Relationships among endogenous ouabain, alpha-adducin polymorphisms and renal sodium handling in primary hypertension. J Hypertens. 2008 May;26(5):914-20. doi: 10.1097/HJH.0b013e3282f5315f.
PubMed 18398333Ferrari P. Rostafuroxin: an ouabain-inhibitor counteracting specific forms of hypertension. Biochim Biophys Acta. 2010 Dec;1802(12):1254-8. doi: 10.1016/j.bbadis.2010.01.009. Epub 2010 Jan 18.
PubMed 20083196Blaustein MP, Chen L, Hamlyn JM, Leenen FH, Lingrel JB, Wier WG, Zhang J. Pivotal role of alpha2 Na+ pumps and their high affinity ouabain binding site in cardiovascular health and disease. J Physiol. 2016 Nov 1;594(21):6079-6103. doi: 10.1113/JP272419. Epub 2016 Jul 31.
PubMed 27350568Manunta P, Iacoviello M, Forleo C, Messaggio E, Hamlyn JM, Lucarelli K, Guida P, Romito R, De Tommasi E, Bianchi G, Rizzon P, Pitzalis MV. High circulating levels of endogenous ouabain in the offspring of hypertensive and normotensive individuals. J Hypertens. 2005 Sep;23(9):1677-81. doi: 10.1097/01.hjh.0000177049.38417.67.
PubMed 16093912Nzietchueng R, El Shamieh S, Benachour H, Labat C, Herbeth B, Ndiaye NC, Masson C, Visvikis-Siest S, Benetos A. Klotho KL-VS genotype is involved in blood pressure regulation. Clin Chim Acta. 2011 Sep 18;412(19-20):1773-7. doi: 10.1016/j.cca.2011.05.032. Epub 2011 Jun 1.
PubMed 21663735Zhou X, Chen K, Lei H, Sun Z. Klotho gene deficiency causes salt-sensitive hypertension via monocyte chemotactic protein-1/CC chemokine receptor 2-mediated inflammation. J Am Soc Nephrol. 2015 Jan;26(1):121-32. doi: 10.1681/ASN.2013101033. Epub 2014 Jun 5.
PubMed 24904083Manunta P, Lavery G, Lanzani C, Braund PS, Simonini M, Bodycote C, Zagato L, Delli Carpini S, Tantardini C, Brioni E, Bianchi G, Samani NJ. Physiological interaction between alpha-adducin and WNK1-NEDD4L pathways on sodium-related blood pressure regulation. Hypertension. 2008 Aug;52(2):366-72. doi: 10.1161/HYPERTENSIONAHA.108.113977. Epub 2008 Jun 30.
PubMed 18591455Citterio L, Simonini M, Zagato L, Salvi E, Delli Carpini S, Lanzani C, Messaggio E, Casamassima N, Frau F, D'Avila F, Cusi D, Barlassina C, Manunta P. Genes involved in vasoconstriction and vasodilation system affect salt-sensitive hypertension. PLoS One. 2011 May 9;6(5):e19620. doi: 10.1371/journal.pone.0019620.
PubMed 21573014Trudu 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 24185693
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
- Hypertension in High School Students: Genetic and Environmental Factors
- ClinicalTrials.gov ID
- NCT06049641
- Acronym / sponsor ID
- HYGEF / HYGEF STUDY
- Conditions
- Hypertension in Adolescence, Adolescent Overweight
- Keywords
- hypertension, adolescence, obesity, genetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,638 participants (actual)
- Lead sponsor
- Ospedale San RaffaeleUniversity, hospital or other
- Study start
- 31 Oct 2014 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 22 Sep 2023 (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.
Hypertension and obesity in the young population are major risk factors for renal and cardiovascular events, which could arise in adulthood. A candidate-gene approach will be applied in a cohort observational study, in which investigators will collect data from high school adolescent students. Participants underwent anthropometric and blood pressure measurements, as well as saliva and urine sample collection for genomic DNA extraction and renal function evaluation, respectively. Candidate genes previously implicated in salt-sensitive hypertension in adults will be tested to verify impact on blood pressure (BP) also among adolescents. Since inflammatory mechanisms may be involved in pathophysiology of hypertension and in endothelial dysfunction and atherosclerosis through reactive oxygen species, the baseline urinary excretion of inflammatory and oxidative stress markers in a subgroup of adolescents stratified according to ADD1 (alpha adducin) rs4961 genotypes will be assessed.
Detailed description
Pediatric hypertension is associated with cardiovascular organ damage, which in turn may lead to cardiovascular disease (CVD) and acute events in adulthood.1 Over the past few decades, the prevalence of hypertension has progressively increased in children and adolescents, generating a significant public health issue and considerable amount of research. BP values among adolescents tend to be less heterogeneous than in adults, and the impact of genetic factors, even if small, may be the expression of pathogenic mechanisms that have been present since birth.
With this study, named HYGEF (Hypertension in high school students: Genetic and Environmental Factors), authors wanted to: 1. determine the prevalence of obesity and hypertension (HT) in a cohort of adolescents, 2. perform genetic analyses to determine a link between specific polymorphisms and/or mutations of genes involved in the development of HT in adults like the Adducin genes and Endogenous Ouabain (EO) and HT and 3. explore whether urine Na+/K+ excretion and urinary markers of inflammation and oxidative stress are linked to HT and cardiovascular risk in participants with the selected genotypes.
Adolescents will be enrolled for the study in high schools in the north (Milan), center (Livorno) and south (Grottaglie) of Italy, to obtain a sample that could be representative of the italian adolescents. During the visit at the high school investigators obtain questionnaires to have some information about eating habits, lifestyle and family history, two (or three in they were very discordant) blood pressure measurements, weight and height of the students, a sample of urine and a sample of saliva to extract DNA.
Genotyping: On the basis of our previous genetic studies carried out in adult patients with hypertension and cardiovascular and renal related diseases, 15 SNPs located in 13 candidate genes have been selected: rs1045642 in ABCB1, rs4343 in ACE (angiotensin converting enzyme), rs4961 in ADD1 (alpha-adducin), rs4984 in ADD2 (beta-adducin), rs3731566 in ADD3 (gamma-adducin), rs11638442 in CYP11A1 (cytochrome P450 family 11 subfamily A member 1), rs1799998 in CYP11B2 (aldosterone synthase), rs2236780, rs6203 and rs10923835 in HSD3B1 genetic region, rs9536314 in KL, rs2254524 in LSS, rs4149601 in neural precursor cell expressed, developmentally down-regulated 4-like, NEDD4L (E3 ubiquitin-protein ligase), PRKG1 (protein kinase, rs1904694 in cGMP-dependent, type I), rs4238595 in UMOD (uromodulin).
Analysis of Urines: Na+, K+, albumin, and creatinine were measured on a first fasting morning urine sample. The Kawasaki formula was used to estimate 24-hour urinary sodium (24h UNa) excretion expressed as mEq/24 h. In a subgroup a urine spot sample for each student will be immediately frozen for protein analysis. Investigators plan to measure simultaneously IL1β, IL6, IL10, IL12p70, TNF-α, MCP1 (monocyte chemoattractant protein), PTX3 (pentraxin-3) by ELISA test using LXSAHM Human Magnetic Luminex Screening Assay. Soluble α- Klotho, 8-Oxo-2'-deoxyguanosine will be measured by Elisa kit assay. Nitric oxide (NO) was measured by the colorimetric Nitric Oxide Assay kit. Advanced Oxidation Protein Products will be measured using the colorimetric OxiSelect Advanced Oxidation Protein Products Assay Kit.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 13 to 15 Year-Old | – | –* Normotensive (Normal BP): SBP and/or DBP values below the 90th percentile for teens of the same age and sex. * Prehypertensive (High-normal BP): SBP and/or DBP values at or above the 90th percentile and/or below the 95th percentile for for teens of the same age and sex. * Hypertensive: SBP and/or DBP values at or above the 95th percentile for teens of the same age and sex. |
| 16 to 19 Year-Old | – | –* Normotensive (Normal BP): SBP <130 mmHg and/or DBP <85 mm Hg. * Prehypertensive (High-normal BP): SBP 130 to 139 mmHg and/or DBP 85 to 89 mm Hg. * Hypertensive: SBP ≥140 mm Hg and/or DBP ≥90 mmHg. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The final sample included 2638 white adolescents, 56% were females, 30% were from Milano (North Italy), 44% from Livorno (central Italy), and 26% from Grottaglie (South Italy).
Key inclusion criteria (2 listed)
- Age between 13 and 19 years old
- Caucasian
Key exclusion criteria (2 listed)
- Age more than 19 years old
- Not Caucasian
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
The aim of the study was to establish a link of specific polymorphisms of Adducins and EO-related genes with selected phenotypes (hypertension, Na+ and K+ intake).
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 7897116de Simone G, Devereux RB, Daniels SR, Koren MJ, Meyer RA, Laragh JH. Effect of growth on variability of left ventricular mass: assessment of allometric signals in adults and children and their capacity to predict cardiovascular risk. J Am Coll Cardiol. 1995 Apr;25(5):1056-62. doi: 10.1016/0735-1097(94)00540-7.
- Background: PubMed 27467768Lurbe E, Agabiti-Rosei E, Cruickshank JK, Dominiczak A, Erdine S, Hirth A, Invitti C, Litwin M, Mancia G, Pall D, Rascher W, Redon J, Schaefer F, Seeman T, Sinha M, Stabouli S, Webb NJ, Wuhl E, Zanchetti A. 2016 European Society of Hypertension guidelines for the management of high blood pressure in children and adolescents. J Hypertens. 2016 Oct;34(10):1887-920. doi: 10.1097/HJH.0000000000001039.
- Background: PubMed 15286277National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004 Aug;114(2 Suppl 4th Report):555-76. No abstract available.
- Background: PubMed 3416162Intersalt: an international study of electrolyte excretion and blood pressure. Results for 24 hour urinary sodium and potassium excretion. Intersalt Cooperative Research Group. BMJ. 1988 Jul 30;297(6644):319-28. doi: 10.1136/bmj.297.6644.319.
- Background: PubMed 20382219Citterio L, Lanzani C, Manunta P, Bianchi G. Genetics of primary hypertension: the clinical impact of adducin polymorphisms. Biochim Biophys Acta. 2010 Dec;1802(12):1285-98. doi: 10.1016/j.bbadis.2010.03.014. Epub 2010 Apr 8.
- Background: PubMed 15528469Efendiev R, Krmar RT, Ogimoto G, Zwiller J, Tripodi G, Katz AI, Bianchi G, Pedemonte CH, Bertorello AM. Hypertension-linked mutation in the adducin alpha-subunit leads to higher AP2-mu2 phosphorylation and impaired Na+,K+-ATPase trafficking in response to GPCR signals and intracellular sodium. Circ Res. 2004 Nov 26;95(11):1100-8. doi: 10.1161/01.RES.0000149570.20845.89. Epub 2004 Nov 4.
- Background: PubMed 18398333Manunta P, Maillard M, Tantardini C, Simonini M, Lanzani C, Citterio L, Stella P, Casamassima N, Burnier M, Hamlyn JM, Bianchi G. Relationships among endogenous ouabain, alpha-adducin polymorphisms and renal sodium handling in primary hypertension. J Hypertens. 2008 May;26(5):914-20. doi: 10.1097/HJH.0b013e3282f5315f.
- Background: PubMed 20083196Ferrari P. Rostafuroxin: an ouabain-inhibitor counteracting specific forms of hypertension. Biochim Biophys Acta. 2010 Dec;1802(12):1254-8. doi: 10.1016/j.bbadis.2010.01.009. Epub 2010 Jan 18.
- Background: PubMed 27350568Blaustein MP, Chen L, Hamlyn JM, Leenen FH, Lingrel JB, Wier WG, Zhang J. Pivotal role of alpha2 Na+ pumps and their high affinity ouabain binding site in cardiovascular health and disease. J Physiol. 2016 Nov 1;594(21):6079-6103. doi: 10.1113/JP272419. Epub 2016 Jul 31.
- Background: PubMed 16093912Manunta P, Iacoviello M, Forleo C, Messaggio E, Hamlyn JM, Lucarelli K, Guida P, Romito R, De Tommasi E, Bianchi G, Rizzon P, Pitzalis MV. High circulating levels of endogenous ouabain in the offspring of hypertensive and normotensive individuals. J Hypertens. 2005 Sep;23(9):1677-81. doi: 10.1097/01.hjh.0000177049.38417.67.
- Background: PubMed 21663735Nzietchueng R, El Shamieh S, Benachour H, Labat C, Herbeth B, Ndiaye NC, Masson C, Visvikis-Siest S, Benetos A. Klotho KL-VS genotype is involved in blood pressure regulation. Clin Chim Acta. 2011 Sep 18;412(19-20):1773-7. doi: 10.1016/j.cca.2011.05.032. Epub 2011 Jun 1.
- Background: PubMed 24904083Zhou X, Chen K, Lei H, Sun Z. Klotho gene deficiency causes salt-sensitive hypertension via monocyte chemotactic protein-1/CC chemokine receptor 2-mediated inflammation. J Am Soc Nephrol. 2015 Jan;26(1):121-32. doi: 10.1681/ASN.2013101033. Epub 2014 Jun 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in Adolescence and Adolescent Overweight, 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 2 inclusion and 2 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aim of the study was to establish a link of specific polymorphisms of Adducins and EO-related genes with selected phenotypes (hypertension, Na+ and K+ intake). (time frame: 2 years). 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 NCT06049641, which also lists 48 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.