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.
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.
Italy3 sites, 3 recruiting
- 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
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.
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.
- First posted29 Jan 2025
- Study start13 Oct 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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.
- 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
- Other
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianna Fabi, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Systemic Hypertension Risk Factors, Complications, Management, and Longitudinal Multidisciplinary Follow-up
- ClinicalTrials.gov ID
- NCT06797908
- Acronym / sponsor ID
- IPERTA / IPERTA
- Conditions
- Hypertension
- Keywords
- hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Jan 2025 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- Patients younger than 18 years of age with hypertension and normal-high blood pressure
Key exclusion criteria (1 listed)
- Patients with normal blood pressure values
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
Description of diagnostic-therapeutic approach of hypertensionin in a pediatric onset
Time frame: through study completion, an average of 1 year
Description of diagnostic-therapeutic approach of hypertensionin in a pediatric onset
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 29 Jan 2025.
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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.
Marianna Fabi, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
3 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 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.