Hypertension; Heart Disease, HypertensiveRCSNNCT02211365
Registro Campania Salute Network on Hypertension
An observational study of Hypertension; Heart Disease, Hypertensive, run by Federico II University at 1 site in Italy.
Trial summary
The Registro Campania Salute Network (RCSN) is a prospective registry aimed at improving the management of essential hypertension by integrating the activity of general practitioners (GPs) with that of the hypertension specialist. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension; Heart Disease, Hypertensive
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2014to Apr 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hypertensive patients
Who may be able to join
- -Hypertension
- 18 years old
Who cannot join
- Refused to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Department od advanced biomedical sciences, Università degli studi di Napoli Federico II, Via sergio Pansini 5
Naples, Napoli, 80131
Raffaele Izzo, MD, +390817462211, rafizzo@unina.it
eugenio Stabile, MD, +393316776019, eugeniostabile@gmail.com
About this study
Official title: Registro Campania Salute Network for the Treatment of Hypertension and Correlated Diseases
The Registro Campania Salute Network (RCSN) is a prospective registry aimed at improving the management of essential hypertension by integrating the activity of general practitioners (GPs) with that of the hypertension specialist. It involves selected GPs homogeneously allocated in the regional area, and the Hypertension Clinic of the Federico II University in Naples, which served as co-ordinating centre. Through the RCSN system it is possible to store clinical data detected at each visit between the peripheral units and the co-ordinating centre and to support scientific analysis of the dataset.
Read the detailed description
The patients will be followed over a period of twenty years and all clinical data will be recorded in order to investigate the role of hypertension and correlated disease on this patient population
- Keywords
- Hypertension, CVD
- Medical subject headings
- Hypertension, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
Major adverse cardiac and cerebrovascular events
Measured: every year up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2017
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hypertension; Heart Disease, HypertensiveStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAFFAELE IZZO, Federico II University
- Investigators
- Bruno Trimarco, MD, Principal investigator, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi di Napoli Federico II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211365
- Sponsor's protocol ID
- 16/14
- Acronym
- RCSN
- Status last verified
- Aug 2025
- First submitted
- 8 Apr 2014
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mancusi C, Basile C, Gerdts E, Fucile I, Manzi MV, Lembo M, Pacella D, Giugliano G, Canciello G, Piccolo R, Spinelli A, Morisco C, De Luca N, Trimarco B, de Simone G, Bossone E, Izzo R, Losi MA, Esposito G. Carotid plaque offsets sex-related differences in cardiovascular risk of young hypertensive patients. Eur J Intern Med. 2024 Dec;130:137-143. doi: 10.1016/j.ejim.2024.09.007. Epub 2024 Sep 17.
PubMed 39294033Trimarco V, Manzi MV, Izzo R, Mone P, Lembo M, Pacella D, Esposito G, Falco A, Morisco C, Gallo P, Santulli G, Trimarco B. The therapeutic concordance approach reduces adverse drug reactions in patients with resistant hypertension. Front Cardiovasc Med. 2023 May 5;10:1137706. doi: 10.3389/fcvm.2023.1137706. eCollection 2023.
PubMed 37215551Lembo M, Acampa W, Rao MAE, Manzi MV, Morisco C, Esposito G, Assante R, Zampella E, Nappi C, Gaudieri V, Mannarino T, Mancusi C, de Simone G, Izzo R, Cuocolo A, Trimarco B. Left Ventricular Mechano-Energetic Efficiency Identifies an Early Impairment of Myocardial Blood Flow in Arterial Hypertension. Hypertension. 2023 Jul;80(7):1534-1543. doi: 10.1161/HYPERTENSIONAHA.123.21071. Epub 2023 May 12.
PubMed 37170833Stabile E, Franzese M, Chianese S, Alfani A, Gerardi D, Colaiori I, Annunziata M, Nappi P, Scalise M, Di Serafino L, Puzone B, Avvedimento M, Leone A, Ilardi F, Piccolo R, Franzone A, Cirillo P, Morisco C, Trimarco B, Esposito G. Predictors of adherence to composite therapy after acute coronary syndromes. J Cardiovasc Med (Hagerstown). 2021 Aug 1;22(8):645-651. doi: 10.2459/JCM.0000000000001201.
PubMed 33966020Mancusi C, Losi MA, Albano G, De Stefano G, Morisco C, Barbato E, Trimarco B, De Luca N, de Simone G, Izzo R. Characteristics and Outcomes of Patients Presenting With Hypertensive Urgency in the Office Setting: The Campania Salute Network. Am J Hypertens. 2020 Apr 29;33(5):414-421. doi: 10.1093/ajh/hpaa003.
PubMed 31930302Canciello G, Mancusi C, Losi MA, Izzo R, Trimarco B, de Simone G, De Luca N. Aortic Root Dilatation Is Associated With Incident Cardiovascular Events in a Population of Treated Hypertensive Patients: The Campania Salute Network. Am J Hypertens. 2018 Nov 13;31(12):1317-1323. doi: 10.1093/ajh/hpy113.
PubMed 30099532Mancusi C, Izzo R, Ferrara LA, Rozza F, Losi MA, Canciello G, Pepe M, de Luca N, Trimarco B, de Simone G. Is increased uric acid a risk factor or a defensive response? The Campania Salute Network. Nutr Metab Cardiovasc Dis. 2018 Aug;28(8):839-846. doi: 10.1016/j.numecd.2018.04.013. Epub 2018 May 4.
PubMed 29898822Izzo R, Losi MA, Stabile E, Lonnebakken MT, Canciello G, Esposito G, Barbato E, De Luca N, Trimarco B, de Simone G. Development of Left Ventricular Hypertrophy in Treated Hypertensive Outpatients: The Campania Salute Network. Hypertension. 2017 Jan;69(1):136-142. doi: 10.1161/HYPERTENSIONAHA.116.08158. Epub 2016 Nov 28.
PubMed 27895192
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registro Campania Salute Network for the Treatment of Hypertension and Correlated Diseases
- ClinicalTrials.gov ID
- NCT02211365
- Acronym / sponsor ID
- RCSN / 16/14
- Keywords
- Hypertension, CVD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2030 (estimated)
- First posted
- 7 Aug 2014 (estimated)
- 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.
The Registro Campania Salute Network (RCSN) is a prospective registry aimed at improving the management of essential hypertension by integrating the activity of general practitioners (GPs) with that of the hypertension specialist. It involves selected GPs homogeneously allocated in the regional area, and the Hypertension Clinic of the Federico II University in Naples, which served as co-ordinating centre. Through the RCSN system it is possible to store clinical data detected at each visit between the peripheral units and the co-ordinating centre and to support scientific analysis of the dataset.
Detailed description
The patients will be followed over a period of twenty years and all clinical data will be recorded in order to investigate the role of hypertension and correlated disease on this patient population
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypertensive patients
Key inclusion criteria (2 listed)
- -Hypertension
- 18 years old
Key exclusion criteria (1 listed)
- Refused to sign informed consent
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
MACCE
Time frame: every year up to 20 years
Major adverse cardiac and cerebrovascular events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Derived from this study: PubMed 39294033Mancusi C, Basile C, Gerdts E, Fucile I, Manzi MV, Lembo M, Pacella D, Giugliano G, Canciello G, Piccolo R, Spinelli A, Morisco C, De Luca N, Trimarco B, de Simone G, Bossone E, Izzo R, Losi MA, Esposito G. Carotid plaque offsets sex-related differences in cardiovascular risk of young hypertensive patients. Eur J Intern Med. 2024 Dec;130:137-143. doi: 10.1016/j.ejim.2024.09.007. Epub 2024 Sep 17.
- Derived from this study: PubMed 37215551Trimarco V, Manzi MV, Izzo R, Mone P, Lembo M, Pacella D, Esposito G, Falco A, Morisco C, Gallo P, Santulli G, Trimarco B. The therapeutic concordance approach reduces adverse drug reactions in patients with resistant hypertension. Front Cardiovasc Med. 2023 May 5;10:1137706. doi: 10.3389/fcvm.2023.1137706. eCollection 2023.
- Derived from this study: PubMed 37170833Lembo M, Acampa W, Rao MAE, Manzi MV, Morisco C, Esposito G, Assante R, Zampella E, Nappi C, Gaudieri V, Mannarino T, Mancusi C, de Simone G, Izzo R, Cuocolo A, Trimarco B. Left Ventricular Mechano-Energetic Efficiency Identifies an Early Impairment of Myocardial Blood Flow in Arterial Hypertension. Hypertension. 2023 Jul;80(7):1534-1543. doi: 10.1161/HYPERTENSIONAHA.123.21071. Epub 2023 May 12.
- Derived from this study: PubMed 33966020Stabile E, Franzese M, Chianese S, Alfani A, Gerardi D, Colaiori I, Annunziata M, Nappi P, Scalise M, Di Serafino L, Puzone B, Avvedimento M, Leone A, Ilardi F, Piccolo R, Franzone A, Cirillo P, Morisco C, Trimarco B, Esposito G. Predictors of adherence to composite therapy after acute coronary syndromes. J Cardiovasc Med (Hagerstown). 2021 Aug 1;22(8):645-651. doi: 10.2459/JCM.0000000000001201.
- Derived from this study: PubMed 31930302Mancusi C, Losi MA, Albano G, De Stefano G, Morisco C, Barbato E, Trimarco B, De Luca N, de Simone G, Izzo R. Characteristics and Outcomes of Patients Presenting With Hypertensive Urgency in the Office Setting: The Campania Salute Network. Am J Hypertens. 2020 Apr 29;33(5):414-421. doi: 10.1093/ajh/hpaa003.
- Derived from this study: PubMed 30099532Canciello G, Mancusi C, Losi MA, Izzo R, Trimarco B, de Simone G, De Luca N. Aortic Root Dilatation Is Associated With Incident Cardiovascular Events in a Population of Treated Hypertensive Patients: The Campania Salute Network. Am J Hypertens. 2018 Nov 13;31(12):1317-1323. doi: 10.1093/ajh/hpy113.
- Derived from this study: PubMed 29898822Mancusi C, Izzo R, Ferrara LA, Rozza F, Losi MA, Canciello G, Pepe M, de Luca N, Trimarco B, de Simone G. Is increased uric acid a risk factor or a defensive response? The Campania Salute Network. Nutr Metab Cardiovasc Dis. 2018 Aug;28(8):839-846. doi: 10.1016/j.numecd.2018.04.013. Epub 2018 May 4.
- Derived from this study: PubMed 27895192Izzo R, Losi MA, Stabile E, Lonnebakken MT, Canciello G, Esposito G, Barbato E, De Luca N, Trimarco B, de Simone G. Development of Left Ventricular Hypertrophy in Treated Hypertensive Outpatients: The Campania Salute Network. Hypertension. 2017 Jan;69(1):136-142. doi: 10.1161/HYPERTENSIONAHA.116.08158. Epub 2016 Nov 28.
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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.
Bruno Trimarco, MD principal investigator
Dipartimento di Scienze Biomediche Avanzate, Università degli Studi di Napoli Federico II
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; Heart Disease, Hypertensive, run by Federico II University 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 1 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: looking for participants now, as of the sponsor's last update on 8 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Trimarco, MD (+390817462250, trimarco@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: every year up to 20 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 NCT02211365, which also lists 8 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 8 Aug 2025.