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NCT06302738 | RECRUITING | Hypertension


Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern
Sponsor:

Italian Auxological Institute

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.

Condition or disease

Hypertension

Sleep Disorder

Intervention/treatment

polysomnography

Study Type : OBSERVATIONAL
Estimated Enrollment : 143 participants
Official Title : PhenotypIsatioN of Sleep Pattern in hyperTensive Patients With blOod Pressure Non-DIPper Status
Actual Study Start Date : 2023-05-04
Estimated Primary Completion Date : 2024-12-31
Estimated Study Completion Date : 2024-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

Phenotypisation of Sleep Pattern in Hypertensive Patients With Non Dipper Pattern

Location Details

NCT06302738


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Locations


RECRUITING

Italy, Italy, Bari

UOSD Arterial Hypertension "A.M. Pirrelli" - AOU Policlinico di Bari, University of Bari,

Bari, Italy, Bari, Italy, 70120

RECRUITING

Italy, Italy, Brindisi

Local Health Authority of the province of Brindisi

Toasts, Italy, Brindisi, Italy, 72100

RECRUITING

Italy, Italy, Novara

Internal Medicine 1, Hypertension and Metabolic Diseases Clinic AOU "Major of charity" - Novara

Novara, Italy, Novara, Italy, 28100

RECRUITING

Italy, Italy, Padova

Padua 1- Medical Clinic 3 · Department of Medicine · Hospital of Padua, Italy

Padua, Italy, Padova, Italy, 35128

RECRUITING

Italy, Italy, Padova

Padua 2 - UOC Emergency Medicine, Regional Center Specialized for Arterial Hypertension OSA - University of Padua Hospital, Italy

Padua, Italy, Padova, Italy, 35128

NOT YET RECRUITING

Italy, Italy, PD

Cardiology Unit, Pneumology Unit, Cittadella Hospital, ULSS 6 Euganea Company, Cittadella, Italy.

Citadel, Italy, PD, Italy, 35013

NOT YET RECRUITING

Italy, Italy, RE

Local Health Unit Company - IRCCS of Reggio Emilia - S.O.S Center for the Treatment of Arterial Hypertension - Cardiovascular Medicine II

Reggio Emilia, Italy, RE, Italy, 42122

NOT YET RECRUITING

Italy, Italy, Trento

Provincial Company for Health Services, Autonomous Province of Trento - Internal Medicine Unit - Rovereto

Rovereto, Italy, Trento, Italy, 38068

NOT YET RECRUITING

Italy, Italy, Trieste

Giuliano-Isontina University Health Authority (ASU-GI)- SC (UCO) Clinical Medicine

Trieste, Italy, Trieste, Italy, 34128

RECRUITING

Italy, Italy, Verona

Department of Medicine, University of Verona, Verona, Italy

Verona, Italy, Verona, Italy, 37126

RECRUITING

Italy, MI

Italian Auxological Institute IRCCS

Milan, MI, Italy, 20149

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