Treatment of nighttime high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the treatment of hypertension that occurs during sleep, focusing on the relationship between blood pressure measurements taken at night and cardiovascular health. It utilizes ambulatory blood pressure monitoring to assess patients' sleep-time blood pressure levels, aiming to establish effective treatment protocols based on these measurements. The study is grounded in recent guidelines that emphasize the importance of nighttime blood pressure control in reducing cardiovascular risks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men and women aged ≥18 years.
2. All participants must: (i) have at randomization sleep-time hypertension according to the current ESH/ESC guidelines, i.e., asleep SBP mean ≥120 mmHg;1 (ii) adhere to a routine of daytime activity and nighttime sleep; and (iii) provide their written informed consent to participate into the study.

Exclusion Criteria:

1. Pregnancy.
2. History of drug/alcohol abuse within the last two years.
3. Night/shift-work employment.
4. Previous history of a systemic autoimmune disease or AIDS.
5. Evidence of a secondary form of hypertension, including coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma
6. CVD disorders (unstable angina pectoris, heart failure, life-threatening arrhythmia, atrial fibrillation, kidney failure, and grade III-IV retinopathy). Previous CVD events will not be exclusionary if full physical and work activities are maintained.
7. Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug, or, at the discretion of the investigator, might place the subject at higher risk from his/her participation in the study, or are likely to prevent the subject from complying with the requirements of the study or completing the trial period.
8. History of malignancy including leukemia and lymphoma (but not basal cell skin cancer), or any other severe, life-threatening disease within the past five years.
9. Inability to communicate and comply with all study requirements.
10. Intolerance to ABPM.

Where it's running

• Complexo Hospitalario Universitario de Ourense
  Ourense, Orense, Spain Recruiting
• CS A Estrada
  A Estrada, Pontevedra, Spain Recruiting
• CS Panxón
  Nigrán, Pontevedra, Spain Recruiting
• Centro de Salud de A Doblada
  Vigo, Pontevedra, Spain Recruiting
• Centro de Salud de Bembrive
  Vigo, Pontevedra, Spain Recruiting
• Centro de Salud de Sardoma
  Vigo, Pontevedra, Spain Recruiting

Study contacts

• Principal investigator: Ramon C Hermida, PhD — University of Vigo
• Study coordinator: Ramon C Hermida, PhD
• Email: rhermida@uvigo.es
• Phone: 34986812148

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.