Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern
NCT ID: NCT06302738
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
143 participants
OBSERVATIONAL
2023-05-04
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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;
polysomnography
patients will undergo a home sleep study to evaluate the presence of sleep disorders
Interventions
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polysomnography
patients will undergo a home sleep study to evaluate the presence of sleep disorders
Eligibility Criteria
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Inclusion Criteria
* 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;
Exclusion Criteria
* atrial fibrillation/flutter;
* pregnancy and lactation;
* terminal malignant disease, life expectancy \<6 months;
* limb amputation;
* dementia.
18 Years
ALL
No
Sponsors
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Istituto Auxologico Italiano
OTHER
Responsible Party
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Principal Investigators
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Gianfranco Parati, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Auxologico Italiano IRCCS
Locations
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UOSD Ipertensione Arteriosa "A.M. Pirrelli" - AUOC Policlinico di Bari, University of Bari,
Bari, Italy, Bari, Italy
Azienda Sanitaria Locale della provincia di Brindisi
Brindisi, Italy, Brindisi, Italy
Medicina Interna 1, Ambulatorio Ipertensione e Malattie Metaboliche AOU "Maggiore della carità"- Novara
Novara, Italy, Novara, Italy
Padova 1- Clinica Medica 3 · Dipartimento di Medicina · Azienda Ospedaliera di Padova, Italy
Padua, Italy, Padova, Italy
Padova 2 - UOC Medicina d'urgenza, Centro Regionale Specializzato per l'ipertensione arteriosa OSA - Azienda ospedaliera Università di Padova, Italy
Padua, Italy, Padova, Italy
UO Cardiologia, UO Pneumologia, Presidio Ospedaliero Cittadella, Azienda ULSS 6 Euganea, Cittadella, Italy.
Cittadella, Italy, PD, Italy
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, Italy
Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento- UO Medicina interna - Rovereto
Rovereto, Italy, Trento, Italy
Azienda sanitaria universitaria Giuliano-Isontina (ASU-GI)- SC (UCO) Medicina Clinica
Trieste, Italy, Trieste, Italy
Department of Medicine, University of Verona, Verona, Italy
Verona, Italy, Verona, Italy
Istituto Auxologico Italiano IRCCS
Milan, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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Luigi Vernaglione, MD
Role: primary
Francesco Dalle Vedove, MD
Role: primary
Other Identifiers
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09C221
Identifier Type: -
Identifier Source: org_study_id
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