Status:
RECRUITING
Treatment of Hypertension During Sleep
Lead Sponsor:
University of Vigo
Conditions:
Hypertension
Hypertension, Systolic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
On the basis of new evidence on the relationship between achieved office blood pressure (BP) measurements (OBPM) and the risk of cardiovascular disease (CVD) morbidity and mortality documented in the ...
Detailed Description
1\. BACKGROUND AND RATIONALE OF THE STUDY. 1.1. Clinic and ambulatory blood pressure for the diagnosis of hypertension. The diagnosis of hypertension and all clinical decisions regarding its treatme...
Eligibility Criteria
Inclusion
- Men and women aged ≥18 years.
- 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
- Pregnancy.
- History of drug/alcohol abuse within the last two years.
- Night/shift-work employment.
- Previous history of a systemic autoimmune disease or AIDS.
- Evidence of a secondary form of hypertension, including coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma
- 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.
- 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.
- 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.
- Inability to communicate and comply with all study requirements.
- Intolerance to ABPM.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
5320 Patients enrolled
Trial Details
Trial ID
NCT03457168
Start Date
February 1 2019
End Date
December 31 2032
Last Update
December 6 2024
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Complexo Hospitalario Universitario de Ourense
Ourense, Orense, Spain, 32005
2
CS A Estrada
A Estrada, Pontevedra, Spain, 26680
3
CS Panxón
Nigrán, Pontevedra, Spain, 36340
4
Centro de Salud de A Doblada
Vigo, Pontevedra, Spain, 36205