PhenotypIsatioN of Sleep Pattern in hyperTensive Patients With blOod Pressure Non-DIPper Status

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \>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;

Locations
Other Locations
Italy
UOSD Ipertensione Arteriosa A.M. Pirrelli - AUOC Policlinico di Bari, University of Bari,
RECRUITING
Bari
Azienda Sanitaria Locale della provincia di Brindisi
RECRUITING
Brindisi
UO Cardiologia, UO Pneumologia, Presidio Ospedaliero Cittadella, Azienda ULSS 6 Euganea, Cittadella, Italy.
NOT_YET_RECRUITING
Cittadella
Istituto Auxologico Italiano IRCCS
RECRUITING
Milan
Medicina Interna 1, Ambulatorio Ipertensione e Malattie Metaboliche AOU Maggiore della carità- Novara
RECRUITING
Novara
Padova 1- Clinica Medica 3 · Dipartimento di Medicina · Azienda Ospedaliera di Padova, Italy
RECRUITING
Padua
Padova 2 - UOC Medicina d'urgenza, Centro Regionale Specializzato per l'ipertensione arteriosa OSA - Azienda ospedaliera Università di Padova, Italy
RECRUITING
Padua
Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia- S.O.S Centro per la Cura dell'Ipertensione Arteriosa- Medicina II Cardiovascolare
NOT_YET_RECRUITING
Reggio Emilia
Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento- UO Medicina interna - Rovereto
NOT_YET_RECRUITING
Rovereto
Azienda sanitaria universitaria Giuliano-Isontina (ASU-GI)- SC (UCO) Medicina Clinica
NOT_YET_RECRUITING
Trieste
Department of Medicine, University of Verona, Verona, Italy
RECRUITING
Verona
Contact Information
Primary
Martino Pengo, MD, PhD
m.pengo@auxologico.it
00390261911
Backup
Elisa Nardin, RN
intodip@auxologico.it
00390261911
Time Frame
Start Date: 2023-05-04
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 143
Treatments
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;
Sponsors
Leads: Istituto Auxologico Italiano

This content was sourced from clinicaltrials.gov