Treatment of nighttime high blood pressure

A Prospective, Randomized, Open-label Clinical Trial on the Effects of Intensive Versus Conventional Control of Ambulatory-determined Asleep Systolic Blood Pressure Mean on Cardiovascular, Metabolic, and Renal Disease Risks

This study tests a new way to treat high blood pressure that happens at night to see if it can help improve heart health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 5320 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Vigo (other)
• Locations: 9 sites (Ourense, Orense and 8 other locations)
• Trial ID: NCT03457168 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18 and older who experience sleep-time hypertension with a mean asleep systolic blood pressure of 120 mmHg or higher.

Not a fit: Patients with certain cardiovascular disorders or secondary forms of hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved management of hypertension during sleep, potentially reducing cardiovascular disease risk for patients.

How similar studies have performed: Other studies have indicated the importance of nighttime blood pressure management, suggesting that this approach may yield beneficial results.

Eligibility criteria

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 this trial is running

Ourense, Orense and 8 other locations

• 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)
• CS Teis — Vigo, Pontevedra, Spain (RECRUITING)
• Bioengineering & Chronobilogy Labs., University of Vigo — Vigo, Pontevedra, Spain (RECRUITING)
• CS San Roque — Vilagarcía de Arousa, Pontevedra, Spain (RECRUITING)

Study contacts

• Principal investigator: Ramon C Hermida, PhD — University of Vigo
• Study coordinator: Ramon C Hermida, PhD

Conditions: Hypertension, Hypertension, Systolic, Sleep-time hypertension, Ambulatory blood pressure monitoring, Hypertension chronotherapy, Asleep blood pressure, Cardiovascular risk, Type 2 diabetes