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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polysomnography | Diagnostic Test | patients will undergo a home sleep study to evaluate the presence of sleep disorders |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with non-dipper status with or without nocturnal hypertension
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martino Pengo, MD, PhD | Contact | 00390261911 | m.pengo@auxologico.it | |
| Elisa Nardin, RN | Contact | 00390261911 | intodip@auxologico.it |
| Name | Affiliation | Role |
|---|---|---|
| Gianfranco Parati, MD | Istituto Auxologico Italiano IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOSD Ipertensione Arteriosa "A.M. Pirrelli" - AUOC Policlinico di Bari, University of Bari, | Recruiting | Bari | Italy, Bari | 70120 | Italy |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D017286 | Polysomnography |
| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Azienda Sanitaria Locale della provincia di Brindisi | Recruiting | Brindisi | Italy, Brindisi | 72100 | Italy |
|
| Medicina Interna 1, Ambulatorio Ipertensione e Malattie Metaboliche AOU "Maggiore della carità"- Novara | Recruiting | Novara | Italy, Novara | 28100 | Italy |
| Padova 1- Clinica Medica 3 · Dipartimento di Medicina · Azienda Ospedaliera di Padova, Italy | Recruiting | Padova | Italy, Padova | 35128 | Italy |
|
| Padova 2 - UOC Medicina d'urgenza, Centro Regionale Specializzato per l'ipertensione arteriosa OSA - Azienda ospedaliera Università di Padova, Italy | Recruiting | Padova | Italy, Padova | 35128 | Italy |
|
| UO Cardiologia, UO Pneumologia, Presidio Ospedaliero Cittadella, Azienda ULSS 6 Euganea, Cittadella, Italy. | Not yet recruiting | Cittadella | Italy, PD | 35013 | Italy |
|
| 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 | Italy, RE | 42122 | Italy |
|
| Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento- UO Medicina interna - Rovereto | Not yet recruiting | Rovereto | Italy, Trento | 38068 | Italy |
|
| Azienda sanitaria universitaria Giuliano-Isontina (ASU-GI)- SC (UCO) Medicina Clinica | Not yet recruiting | Trieste | Italy, Trieste | 34128 | Italy |
|
| Department of Medicine, University of Verona, Verona, Italy | Recruiting | Verona | Italy, Verona | 37126 | Italy |
|
| Istituto Auxologico Italiano IRCCS | Recruiting | Milan | MI | 20149 | Italy |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |