HypertensionINTO-DIPNCT06302738
Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern
An observational study of Hypertension and Sleep Disorder, run by Istituto Auxologico Italiano at 11 sites in Italy.
Trial summary
High blood pressure is the most common modifiable risk factor for cardiovascular diseases (CV). The large interindividual variability in clinical expression of the disease and response to treatment, however, makes the management of the hypertensive patient complex.Therefore, identifying phenotypes of hypertensive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Sleep Disorder
- What is being tested?
- polysomnography
- How many people
- 143 participants
- Where
- 11 sitesItaly
- Study dates
- 4 May 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients with non-dipper status with or without nocturnal hypertension
Who may be able to join
- >18 years old;
- arterial hypertension defined as: a) office systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg AND either 24-hour ambulatory systolic BP ≥130 mmHg and/or diastolic BP ≥80 mmHg OR b) the presence of antihypertensive treatment;
- non-dipper pattern at 24-hour BP monitoring (confirmed on repeated ABPM including one performed within 3 months prior to enrolment and one after enrolment, both on the same antihypertensive treatment, if any), defined as a nocturnal decrease systolic and/or in diastolic BP values <10% compared to the corresponding daytime values;
- signed written informed consent;
Who cannot join
- shift workers
- atrial fibrillation/flutter;
- pregnancy and lactation;
- terminal malignant disease, life expectancy <6 months;
- limb amputation;
- dementia.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Italy11 sites, 11 recruiting
- Recruiting
UOSD Ipertensione Arteriosa "A.M. Pirrelli" - AUOC Policlinico di Bari, University of Bari,
Bari, Italy, Bari, 70120
Sebastiano Cicco, MD, sebastiano.cicco@uniba.it
- Recruiting
Azienda Sanitaria Locale della provincia di Brindisi
Brindisi, Italy, Brindisi, 72100
Luigi Vernaglione, MD, 003908311882006
- Not yet recruiting
UO Cardiologia, UO Pneumologia, Presidio Ospedaliero Cittadella, Azienda ULSS 6 Euganea, Cittadella, Italy.
Cittadella, Italy, PD, 35013
Francesca Saladini, MD, 00390499424531, francesca.saladini@alss6.veneto.it
- Recruiting
Istituto Auxologico Italiano IRCCS
Milan, MI, 20149
Martino Pengo, MD, PhD, 00390261911, m.pengo@auxologico.it
Elisa Nardin, 00390261911, e.nardin@auxologico.it
- Recruiting
Medicina Interna 1, Ambulatorio Ipertensione e Malattie Metaboliche AOU "Maggiore della carità"- Novara
Novara, Italy, Novara, 28100
- Recruiting
Padova 1- Clinica Medica 3 · Dipartimento di Medicina · Azienda Ospedaliera di Padova, Italy
Padova, Italy, Padova, 35128
Maria Teresa Seccia, MD, PhD, 00390498212263, teresamaria.seccia@unipd.it
- Recruiting
Padova 2 - UOC Medicina d'urgenza, Centro Regionale Specializzato per l'ipertensione arteriosa OSA - Azienda ospedaliera Università di Padova, Italy
Padova, Italy, Padova, 35128
Giuseppe Maiolino, MD, 00390498212872, giuseppe.maiolino@gmail.com
- Not yet recruiting
Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia- S.O.S Centro per la Cura dell'Ipertensione Arteriosa- Medicina II Cardiovascolare
Reggio Emilia, Italy, RE, 42122
Chiara Grasselli, MD, chiara.grasselli@ausl.re.it
- Not yet recruiting
Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento- UO Medicina interna - Rovereto
Rovereto, Italy, Trento, 38068
Francesco Dalle Vedove, MD
- Not yet recruiting
Azienda sanitaria universitaria Giuliano-Isontina (ASU-GI)- SC (UCO) Medicina Clinica
Trieste, Italy, Trieste, 34128
Andrea Grillo, MD, PhD, 00390403994619, andrea.grillo@asugi.sanita.fvg.it
- Recruiting
Department of Medicine, University of Verona, Verona, Italy
Verona, Italy, Verona, 37126
Cristiano Fava, MD, PhD, 00390458124732, cristiano.fava@univr.it
About this study
Official title: PhenotypIsatioN of Sleep Pattern in hyperTensive Patients With blOod Pressure Non-DIPper Status
High blood pressure is the most common modifiable risk factor for cardiovascular diseases (CV). The large interindividual variability in clinical expression of the disease and response to treatment, however, makes the management of the hypertensive patient complex.Therefore, identifying phenotypes of hypertensive patients associated with a specific CV outcome or who tend to respond/not respond to treatment is of paramount importance for improving CV prevention.
It has been shown that the phenotype of hypertensive patient with poor control of nighttime blood pressure values, especially when associated with a "non-dipper" profile, was associated with an increased risk of developing CV and cerebrovascular complications.
Read more
The non-dipper profile and nocturnal hypertension are caused by several factors including excessive salt intake and dysautonomia. However, they are also inevitably influenced by sleep duration and the presence of sleep disorders: obstructive sleep apnea (OSA), but also insomnia and periodic movements of the lower limbs,such as those frequently seen in restless legs syndrome, are among the the main determinants related to altered nighttime pressure pattern. However, such disturbances are not systematically assessed during the performance of monitoring 24h pressor and their impact in the outcome of the hypertensive patient is unknown.
The primary objective of this study is to phenotype non-dipper patients with or without nocturnal hypertension to determine the prevalence of sleep disorders such as sleep apnea syndrome, insomnia, and restless legs syndrome (RLS) (OSA diagnosed considering AHI>5 events/hour, insomnia and RLS according to ICSD 3 criteria) and correlate the presence of various sleep disorders with cardiac organ damage, vascular, and renal damage mediated by hypertension.
- Conditions
- Hypertension, Sleep Disorder
- Being tested
- polysomnography
- Medical subject headings
- Hypertension, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnographyDiagnostic test
patients will undergo a home sleep study to evaluate the presence of sleep disorders
| Study group | Role | What they receive |
|---|---|---|
| Non-dipper pattern at 24-hour BP monitoring | Defined as a nocturnal decrease systolic and/or in diastolic BP values <10% compared to the corresponding daytime values; Receives: Diagnostic Test: polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sleep disorders
Phenotype patients with non-dipper status with or without nocturnal hypertension in order to establish the prevalence of sleep disturbances such as sleep apnea syndrome, insomnia and restless legs syndrome
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start4 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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
- Cross-sectional
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gianfranco Parati, MD, Principal investigator, Istituto Auxologico Italiano IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302738
- Sponsor's protocol ID
- 09C221
- Acronym
- INTO-DIP
- Status last verified
- Apr 2024
- First submitted
- 4 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhenotypIsatioN of Sleep Pattern in hyperTensive Patients With blOod Pressure Non-DIPper Status
- ClinicalTrials.gov ID
- NCT06302738
- Acronym / sponsor ID
- INTO-DIP / 09C221
- Conditions
- Hypertension, Sleep Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 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.
High blood pressure is the most common modifiable risk factor for cardiovascular diseases (CV). The large interindividual variability in clinical expression of the disease and response to treatment, however, makes the management of the hypertensive patient complex.Therefore, identifying phenotypes of hypertensive patients associated with a specific CV outcome or who tend to respond/not respond to treatment is of paramount importance for improving CV prevention.
It has been shown that the phenotype of hypertensive patient with poor control of nighttime blood pressure values, especially when associated with a "non-dipper" profile, was associated with an increased risk of developing CV and cerebrovascular complications.
The non-dipper profile and nocturnal hypertension are caused by several factors including excessive salt intake and dysautonomia. However, they are also inevitably influenced by sleep duration and the presence of sleep disorders: obstructive sleep apnea (OSA), but also insomnia and periodic movements of the lower limbs,such as those frequently seen in restless legs syndrome, are among the the main determinants related to altered nighttime pressure pattern. However, such disturbances are not systematically assessed during the performance of monitoring 24h pressor and their impact in the outcome of the hypertensive patient is unknown.
The primary objective of this study is to phenotype non-dipper patients with or without nocturnal hypertension to determine the prevalence of sleep disorders such as sleep apnea syndrome, insomnia, and restless legs syndrome (RLS) (OSA diagnosed considering AHI>5 events/hour, insomnia and RLS according to ICSD 3 criteria) and correlate the presence of various sleep disorders with cardiac organ damage, vascular, and renal damage mediated by hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-dipper pattern at 24-hour BP monitoring | – | Diagnostic Test: polysomnographyDefined as a nocturnal decrease systolic and/or in diastolic BP values <10% compared to the corresponding daytime values; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-dipper status with or without nocturnal hypertension
Key inclusion criteria (4 listed)
- >18 years old;
- arterial hypertension defined as: a) office systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg AND either 24-hour ambulatory systolic BP ≥130 mmHg and/or diastolic BP ≥80 mmHg OR b) the presence of antihypertensive treatment;
- non-dipper pattern at 24-hour BP monitoring (confirmed on repeated ABPM including one performed within 3 months prior to enrolment and one after enrolment, both on the same antihypertensive treatment, if any), defined as a nocturnal decrease systolic and/or in diastolic BP values <10% compared to the corresponding daytime values;
- signed written informed consent;
Key exclusion criteria (6 listed)
- shift workers
- atrial fibrillation/flutter;
- pregnancy and lactation;
- terminal malignant disease, life expectancy <6 months;
- limb amputation;
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 |
|---|---|---|
| polysomnographypatients will undergo a home sleep study to evaluate the presence of sleep disorders | Diagnostic test | Non-dipper pattern at 24-hour BP monitoring |
Primary outcome
Prevalence of sleep disorders
Time frame: baseline
Phenotype patients with non-dipper status with or without nocturnal hypertension in order to establish the prevalence of sleep disturbances such as sleep apnea syndrome, insomnia and restless legs syndrome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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. This study is not recruiting at the moment.
Gianfranco Parati, MD principal investigator
Istituto Auxologico Italiano IRCCS
11 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 and Sleep Disorder, run by Istituto Auxologico Italiano at 11 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martino Pengo, MD, PhD (00390261911, m.pengo@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sleep disorders (time frame: baseline). 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 16 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.