Clinical trial NCT06302738: Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern
Official title: PhenotypIsatioN of Sleep Pattern in hyperTensive Patients With blOod Pressure Non-DIPper Status
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Sleep Disorder
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-dipper status with or without nocturnal hypertension

Brief 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 criteria: Inclusion Criteria:

* \>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;

Exclusion Criteria:

* shift workers
* atrial fibrillation/flutter;
* pregnancy and lactation;
* terminal malignant disease, life expectancy \<6 months;
* limb amputation;
* dementia.

Primary outcomes:
measure: Prevalence of sleep disorders
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: UOSD Ipertensione Arteriosa "A.M. Pirrelli" - AUOC Policlinico di Bari, University of Bari,
state: Italy, Bari
city: Brindisi
country: Italy
facility: Azienda Sanitaria Locale della provincia di Brindisi
state: Italy, Brindisi
city: Novara
country: Italy
facility: Medicina Interna 1, Ambulatorio Ipertensione e Malattie Metaboliche AOU "Maggiore della carità"- Novara
state: Italy, Novara
city: Padova
country: Italy
facility: Padova 1- Clinica Medica 3 · Dipartimento di Medicina · Azienda Ospedaliera di Padova, Italy
state: Italy, Padova
city: Padova
country: Italy
facility: Padova 2 - UOC Medicina d'urgenza, Centro Regionale Specializzato per l'ipertensione arteriosa OSA - Azienda ospedaliera Università di Padova, Italy
state: Italy, Padova
city: Cittadella
country: Italy
facility: UO Cardiologia, UO Pneumologia, Presidio Ospedaliero Cittadella, Azienda ULSS 6 Euganea, Cittadella, Italy.
state: Italy, PD
city: Reggio Emilia
country: Italy
facility: Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia- S.O.S Centro per la Cura dell'Ipertensione Arteriosa- Medicina II Cardiovascolare
state: Italy, RE
city: Rovereto
country: Italy
facility: Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento- UO Medicina interna - Rovereto
state: Italy, Trento
city: Trieste
country: Italy
facility: Azienda sanitaria universitaria Giuliano-Isontina (ASU-GI)- SC (UCO) Medicina Clinica
state: Italy, Trieste
city: Verona
country: Italy
facility: Department of Medicine, University of Verona, Verona, Italy
state: Italy, Verona
city: Milano
country: Italy
facility: Istituto Auxologico Italiano IRCCS
state: MI
Study officials:
affiliation: Istituto Auxologico Italiano IRCCS
name: Gianfranco Parati, MD
role: PRINCIPAL_INVESTIGATOR
References: