Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern

Hypertension Clinical Trial

— INTO-DIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302738
• Other study ID #: 09C221
• Status: Recruiting
• Start date: May 4, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Istituto Auxologico Italiano
• Contact: Martino Pengo, MD, PhD
• Phone: 00390261911
• Email: m.pengo[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 143
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Diagnostic Test:
• polysomnography
patients will undergo a home sleep study to evaluate the presence of sleep disorders

Locations

Country	Name	City	State
Italy	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	UO Cardiologia, UO Pneumologia, Presidio Ospedaliero Cittadella, Azienda ULSS 6 Euganea, Cittadella, Italy.	Cittadella	Italy, PD
Italy	Istituto Auxologico Italiano IRCCS	Milano	MI
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	Padova	Italy, Padova
Italy	Padova 2 - UOC Medicina d'urgenza, Centro Regionale Specializzato per l'ipertensione arteriosa OSA - Azienda ospedaliera Università di Padova, Italy	Padova	Italy, Padova
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

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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