NCT06797908

Brief Summary

We decided to conduct this study because hypertension in childhood increases the risk of developing cardiovascular disease (such as heart attack or stroke) in adulthood, beginning to damage important structures and organs, such as blood vessels, heart, and kidneys, from an early age. There is a clear need to identify those at greatest risk of developing hypertension as early as possible and to follow them appropriately. The main objectives of the study are to describe the causes of hypertension, study the clinical-laboratory features in the patient with hypertension (such as associated symptoms or conditions, or altered blood test values), evaluate the possible involvement of the heart, and describe the overall approach to the patient with hypertension, from diagnosis (i.e., identification of the condition) to treatment.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

3 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 Start

First participant enrolled

October 13, 2020

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 29, 2025

Status Verified

October 1, 2024

Enrollment Period

5.2 years

First QC Date

December 3, 2024

Last Update Submit

January 22, 2025

Conditions

Keywords

hypertension

Outcome Measures

Primary Outcomes (1)

  • Description of diagnostic-therapeutic approach of hypertensionin in a pediatric onset

    Description of diagnostic-therapeutic approach of hypertensionin in a pediatric onset

    through study completion, an average of 1 year

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The population will consist of inpatients and outpatients referred to the Center with a diagnosis of hypertension and normal-high blood pressure, according to the European Society of Hypertension Guidelines1

You may qualify if:

  • Patients younger than 18 years of age with hypertension and normal-high blood pressure

You may not qualify if:

  • Patients with normal blood pressure values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Cardiologia Pediatrica e dell'età evolutiva

Bologna, Bologna, 40133, Italy

RECRUITING

IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria d'Urgenza, Pronto Soccorso e Osservazione Breve ed Intensiva

Bologna, Bologna, 40133, Italy

RECRUITING

IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Pediatria

Bologna, Bologna, 40133, Italy

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Marianna Fabi, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianna Fabi, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 3, 2024

First Posted

January 29, 2025

Study Start

October 13, 2020

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 29, 2025

Record last verified: 2024-10

Locations