Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern

NCT06302738 | Recruiting DMC

• 1 other identifier: 09C221
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 11

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.

Conditions

Hypertension; Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  baseline

Study Arms (1)

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;

Diagnostic Test: polysomnography

Interventions

polysomnography DIAGNOSTIC_TEST

patients will undergo a home sleep study to evaluate the presence of sleep disorders

Non-dipper pattern at 24-hour BP monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non-dipper status with or without nocturnal hypertension

You may qualify if:

• \>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;

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (11)

UOSD Ipertensione Arteriosa "A.M. Pirrelli" - AUOC Policlinico di Bari, University of Bari,

Bari, Italy, Bari, 70120, Italy

RECRUITING

Azienda Sanitaria Locale della provincia di Brindisi

Brindisi, Italy, Brindisi, 72100, Italy

RECRUITING

Medicina Interna 1, Ambulatorio Ipertensione e Malattie Metaboliche AOU "Maggiore della carità"- Novara

Novara, Italy, Novara, 28100, Italy

RECRUITING

Padova 1- Clinica Medica 3 · Dipartimento di Medicina · Azienda Ospedaliera di Padova, Italy

Padua, Italy, Padova, 35128, Italy

RECRUITING

Padova 2 - UOC Medicina d'urgenza, Centro Regionale Specializzato per l'ipertensione arteriosa OSA - Azienda ospedaliera Università di Padova, Italy

Padua, Italy, Padova, 35128, Italy

RECRUITING

UO Cardiologia, UO Pneumologia, Presidio Ospedaliero Cittadella, Azienda ULSS 6 Euganea, Cittadella, Italy.

Cittadella, Italy, PD, 35013, Italy

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, Italy

NOT YET RECRUITING

Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento- UO Medicina interna - Rovereto

Rovereto, Italy, Trento, 38068, Italy

NOT YET RECRUITING

Azienda sanitaria universitaria Giuliano-Isontina (ASU-GI)- SC (UCO) Medicina Clinica

Trieste, Italy, Trieste, 34128, Italy

NOT YET RECRUITING

Department of Medicine, University of Verona, Verona, Italy

Verona, Italy, Verona, 37126, Italy

RECRUITING

Istituto Auxologico Italiano IRCCS

Milan, MI, 20149, Italy

RECRUITING

MeSH Terms

Conditions

Hypertension; Sleep Wake Disorders

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gianfranco Parati, MD

  Istituto Auxologico Italiano IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martino Pengo, MD, PhD

CONTACT

00390261911; m.pengo@auxologico.it

Elisa Nardin, RN

CONTACT

00390261911; intodip@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: May 4, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

IT (11)