HypertensionSEVR-HTNCT06309511
Subendocardial Viability Ratio in Hypertension
An observational study of Hypertension, run by Istituto Auxologico Italiano at 5 sites in Italy.
Trial summary
The aim of the research is to evaluate the Subendocardial Viability Ratio (SEVR) in hypertensive patients, using non-invasive arterial tonometry, and to establish the influencing factors and the possibility of predicting cardiovascular morbidity and mortality in arterial hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Arterial tonometry
- How many people
- 3,000 participants
- Where
- 5 sitesItaly
- Study dates
- 1 Oct 2022to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hypertensive patients
Who may be able to join
- Hypertension
Who cannot join
- Atrial fibrillation
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
Unità Operativa Semplice Dipartimentale Ipertensione Arteriosa "Anna Maria Pirrelli", Università degli Studi di Bari "Aldo Moro". Policlinico Consorziale di Bari
Bari
Pietro Nazzaro, MD, pietro.nazzaro@uniba.it
Sebastiano Cicco, MD, sebastiano.cicco@uniba.it
- Recruiting
Centro di Prevenzione e Cura dell'Ipertensione Arteriosa "Alessandro Filippi"
Mascalucia, Catania
Antonino Di Guardo, MD, ninodiguardo58@gmail.com
Massimo Catanuso, MD, catanusomassimo@hotmail.it
- Recruiting
Istituto Auxologico Italiano IRCCS
Milan, 20145
Paolo Salvi, MD, +390261911 ext. 2968, p.salvi@auxologico.it
- Recruiting
Medicina II Cardiovascolare, AUSL-IRCCS di Reggio Emilia
Reggio Emilia
Angelo Ghirarduzzi, MD, ghirarduzzi.angelo@ausl.re.it
Chiara Grasselli, MD, chiara.grasselli@ausl.re.it
- Recruiting
Dipartimento di Scienze Mediche, Chirurgiche e della Salute, Università degli studi di Trieste
Trieste
Andrea Grillo, MD, andr.grillo@gmail.com
Bruno Fabris, MD, b.fabris@fmc.units.it
About this study
The aim of the research is to evaluate the Subendocardial Viability Ratio (SEVR) in hypertensive patients, using non-invasive arterial tonometry, and to establish the influencing factors and the possibility of predicting cardiovascular morbidity and mortality in arterial hypertension.
The SEVR will be evaluated on all patients belonging to the Arterial Hypertension Centers undergoing non-invasive arterial tonometry.
Read more
The SEVR is calculated on the morphology of the central pressure wave as the ratio between the DPTI (diastolic pressure-time index), i.e. the area between the carotid pressure curve and the ventricular pressure curve during the diastolic phase, and the SPTI ( systolic pressure-time index), i.e. the area under the carotid pressure curve during the systolic phase.
The SEVR will be correlated with the anthropometric and pathology variables which will be collected in an appropriate database.
- Conditions
- Hypertension
- Being tested
- Arterial tonometry
- Keywords
- Myocardial ischemia, Buckberg index
- Medical subject headings
- Hypertension, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial tonometryDiagnostic test
Arterial transcutaneous tonometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Buckberg index
Assessment of subendocardial viability ratio (SEVR)
Measured: At recruitment, at 1 year, 2 years, 3 years and 4 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Oct 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309511
- Sponsor's protocol ID
- 09C218
- Acronym
- SEVR-HT
- Status last verified
- Aug 2025
- First submitted
- 7 Mar 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subendocardial Viability Ratio in Hypertension
- ClinicalTrials.gov ID
- NCT06309511
- Acronym / sponsor ID
- SEVR-HT / 09C218
- Conditions
- Hypertension
- Keywords
- Myocardial ischemia, Buckberg index
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Mar 2024 (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.
The aim of the research is to evaluate the Subendocardial Viability Ratio (SEVR) in hypertensive patients, using non-invasive arterial tonometry, and to establish the influencing factors and the possibility of predicting cardiovascular morbidity and mortality in arterial hypertension.
The SEVR will be evaluated on all patients belonging to the Arterial Hypertension Centers undergoing non-invasive arterial tonometry.
The SEVR is calculated on the morphology of the central pressure wave as the ratio between the DPTI (diastolic pressure-time index), i.e. the area between the carotid pressure curve and the ventricular pressure curve during the diastolic phase, and the SPTI ( systolic pressure-time index), i.e. the area under the carotid pressure curve during the systolic phase.
The SEVR will be correlated with the anthropometric and pathology variables which will be collected in an appropriate database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypertensive patients
Key inclusion criteria (1 listed)
- Hypertension
Key exclusion criteria (1 listed)
- Atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial tonometryArterial transcutaneous tonometry | Diagnostic test | – |
Primary outcome
Buckberg index
Time frame: At recruitment, at 1 year, 2 years, 3 years and 4 years of follow-up
Assessment of subendocardial viability ratio (SEVR)
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 3 Aug 2025.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Istituto Auxologico Italiano at 5 sites 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 1 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 3 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 5 sites 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 Paolo Salvi, MD (+390261911 ext. 2968, p.salvi@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buckberg index (time frame: At recruitment, at 1 year, 2 years, 3 years and 4 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2025; AzTrials last refreshed its copy on 2 Nov 2026.