NCT06309511

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Oct 2022Dec 2026

Study Start

First participant enrolled

October 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 3, 2025

Status Verified

August 1, 2025

Enrollment Period

4.3 years

First QC Date

March 7, 2024

Last Update Submit

August 1, 2025

Conditions

Keywords

Myocardial ischemiaBuckberg index

Outcome Measures

Primary Outcomes (1)

  • Buckberg index

    Assessment of subendocardial viability ratio (SEVR)

    At recruitment, at 1 year, 2 years, 3 years and 4 years of follow-up

Interventions

Arterial tonometryDIAGNOSTIC_TEST

Arterial transcutaneous tonometry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hypertensive patients

You may qualify if:

  • Hypertension

You may not qualify if:

  • Atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centro di Prevenzione e Cura dell'Ipertensione Arteriosa "Alessandro Filippi"

Mascalucia, Catania, Italy

RECRUITING

Unità Operativa Semplice Dipartimentale Ipertensione Arteriosa "Anna Maria Pirrelli", Università degli Studi di Bari "Aldo Moro". Policlinico Consorziale di Bari

Bari, Italy

RECRUITING

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

RECRUITING

Medicina II Cardiovascolare, AUSL-IRCCS di Reggio Emilia

Reggio Emilia, Italy

RECRUITING

Dipartimento di Scienze Mediche, Chirurgiche e della Salute, Università degli studi di Trieste

Trieste, Italy

RECRUITING

MeSH Terms

Conditions

HypertensionMyocardial Ischemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHeart Diseases

Central Study Contacts

Paolo Salvi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2024

First Posted

March 13, 2024

Study Start

October 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations