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HypertensionIPERTANCT06797908

Systemic Arterial Hypertension in Pediatric Age.

An observational study of Hypertension, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Hypertension
How many people
350 participants
Where
3 sitesItaly
Study dates
13 Oct 2020to 31 Dec 2025
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 Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

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

Who cannot join

  • Patients with normal blood pressure values

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marianna Fabi, MD contact

0512143012

marianna.fabi@aosp.bo.it

Italy3 sites, 3 recruiting
  • IRCCS Azienda Ospedaliero - Universitaria di Bologna, U.O. Cardiologia Pediatrica e dell'età evolutiva

    Bologna, Bologna, 40133

    Anna Balducci, MD, 0512143012, anna.balducci@aosp.bo.it

    Anna Balducci, MD

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

    Bologna, Bologna, 40133

    Marianna Fabi, MD, 0512143012, francesca.lombardi@ausl.bologna.it

    Marianna Fabi

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

    Bologna, Bologna, 40133

    Giulio Maltoni, MD, 051 2144816, giulio.maltoni@aosp.bo.it

    Giulio Maltoni, MD

    Recruiting

Other trials in Italy

About this study

Official title: Pediatric Systemic Hypertension Risk Factors, Complications, Management, and Longitudinal Multidisciplinary Follow-up

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.

Read the detailed description

The presence and identification of systemic arterial hypertension (hypertension, HTN) in pediatric age has become increasingly relevant in recent years as a consequence of the increase in its prevalence, linked to the change in health determinants witnessed since the late 1970s, such as sedentariness and increased overweight.

In view of the epidemiological consistency of HTN in pediatric age with the possible complications and repercussions in later ages as well, and the economic burden of the management of this patient beginning in early life, both European and North American Guidelines for the child and adolescent on the identification of the individual at risk for HTN and his or her behavioral-pharmacological therapeutic management have been published.

The prevalence of HTN is about 3.5%, while that of elevated blood pressure (BP) is between 2.2 and 3.5% depending on the studies and the population considered, highest in overweight and obese subjects, in whom HTN affects up to 25 percent of subjects, with an increasing incidence trend since the 1980s until reaching a plateau in recent years, consensual with that of obesity. These data underscore the existence of a linear correlation between obesity, metabolic syndrome, and increased blood pressure. Other known conditions that increase the risk of HTN occurrence are prematurity, type 1 diabetes, nephro-vascular and renal diseases with chronic nephropathy, and sleep disorders. Guidance on the definition, diagnosis, and management is provided not only for pathological hypertension but also for high blood pressure values: it has, in fact, been shown that even blood pressure values that are not frankly pathological but nonetheless high can cause organ damage and tend to increase and become pathological within 2 years if left untreated.Longitudinal study cohorts initiated in the 1970s-1980s in both Europe (Young Finns Study) and North America (Framingham Heart Study, Bogalusa Heart Study) have shown that hypertension and cardiovascular (CV) risk factors already present in pediatric age increase CV morbidity and mortality in adults as in a progression of the march of disease. Considering the cardiovascular risk both in the short and long term to which a child diagnosed with systemic hypertension or with normal-to-high blood pressure values is exposed, and the interdependence with metabolic syndrome, endocrine and chronic nephrological pathologies, there is a clear need to identify as early as possible those at higher risk of developing HTN and to appropriately follow up those with elevated blood pressure through early and personalized multidisciplinary interventions. The possibility of recording even longitudinally the evolution of 'possible multidistrict organ damage and its response to treatment could allow us to always modulate therapeutic intervention from the very early stages of the disease and even before the appearance of pathological values. This type of approach would allow us to reduce CV mortality and morbidity even in later ages. The present study is intended to describe the phenomenon of pediatric hypertension with a multidisciplinary approach (cardiovascular, endocrinological and metabolic, and nephrological), with the aim of making the diagnostic-therapeutic-care pathway more effective.

Conditions
Hypertension
Keywords
hypertension
Medical subject headings
Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2025
  2. Study start13 Oct 2020
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Other
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06797908
Sponsor's protocol ID
IPERTA
Acronym
IPERTA
Status last verified
Oct 2024
First submitted
3 Dec 2024
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 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 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 Marianna Fabi, MD (0512143012, marianna.fabi@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Description of diagnostic-therapeutic approach of hypertensionin in a pediatric onset (time frame: through study completion, an average of 1 year). 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 29 Jan 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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