Identifying sleep patterns in hypertensive patients with non-dipper profiles

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

This study looks at the sleep patterns of people with high blood pressure who don't experience normal nighttime drops in blood pressure to see how those patterns affect their heart health and treatment.

Quick facts

• Study type: Observational
• Enrollment: 143 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Istituto Auxologico Italiano (other)
• Locations: 11 sites (Bari, Italy, Bari and 10 other locations)
• Trial ID: NCT06302738 on ClinicalTrials.gov

What this trial studies

This observational study aims to characterize the sleep patterns of hypertensive patients who exhibit a non-dipper blood pressure profile. It focuses on understanding how these sleep patterns relate to cardiovascular outcomes and treatment responses. Participants will undergo polysomnography to assess their sleep quality and duration, which may be influenced by factors such as sleep disorders and lifestyle choices. The study seeks to improve cardiovascular prevention strategies by identifying specific phenotypes of hypertensive patients.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with arterial hypertension and a confirmed non-dipper blood pressure pattern.

Not a fit: Patients with conditions such as atrial fibrillation, terminal malignant disease, or those who are pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment approaches for hypertensive patients, potentially reducing cardiovascular risks.

How similar studies have performed: Other studies have shown success in identifying sleep disorders in hypertensive patients, suggesting that this approach may yield valuable insights.

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.

Where this trial is running

Bari, Italy, Bari and 10 other locations

• UOSD Ipertensione Arteriosa "A.M. Pirrelli" - AUOC Policlinico di Bari, University of Bari, — Bari, Italy, Bari, Italy (RECRUITING)
• Azienda Sanitaria Locale della provincia di Brindisi — Brindisi, Italy, Brindisi, Italy (RECRUITING)
• Medicina Interna 1, Ambulatorio Ipertensione e Malattie Metaboliche AOU "Maggiore della carità"- Novara — Novara, Italy, Novara, Italy (RECRUITING)
• Padova 1- Clinica Medica 3 · Dipartimento di Medicina · Azienda Ospedaliera di Padova, Italy — Padova, Italy, Padova, Italy (RECRUITING)
• Padova 2 - UOC Medicina d'urgenza, Centro Regionale Specializzato per l'ipertensione arteriosa OSA - Azienda ospedaliera Università di Padova, Italy — Padova, Italy, Padova, Italy (RECRUITING)
• UO Cardiologia, UO Pneumologia, Presidio Ospedaliero Cittadella, Azienda ULSS 6 Euganea, Cittadella, Italy. — Cittadella, Italy, PD, 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, Italy (NOT_YET_RECRUITING)
• Azienda Provinciale per i Servizi Sanitari, Provincia Autonoma di Trento- UO Medicina interna - Rovereto — Rovereto, Italy, Trento, Italy (NOT_YET_RECRUITING)
• Azienda sanitaria universitaria Giuliano-Isontina (ASU-GI)- SC (UCO) Medicina Clinica — Trieste, Italy, Trieste, Italy (NOT_YET_RECRUITING)
• Department of Medicine, University of Verona, Verona, Italy — Verona, Italy, Verona, Italy (RECRUITING)
• Istituto Auxologico Italiano IRCCS — Milano, MI, Italy (RECRUITING)

Study contacts

• Principal investigator: Gianfranco Parati, MD — Istituto Auxologico Italiano IRCCS
• Study coordinator: Martino Pengo, MD, PhD

Conditions: Hypertension, Sleep Disorder