Lowering Blood Pressure During Sleep in Adults With Hypertension
Compares stricter and standard sleep blood pressure targets in adults with high blood pressure.
Plain-language title generated from the registry record
Registry title: Treatment of Hypertension During Sleep
Key facts
- Where
- A Estrada, Nigrán, Ourense, Vigo, and Vilagarcía de Arousa, SpainSee the 9 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high blood pressure during sleep. It compares a lower and a usual target for blood pressure while asleep.
- Age
- 18 years and older
- Sex
- Men and women
- Disease stage
- High blood pressure during sleep: average top (systolic) blood pressure while asleep of 120 mmHg or more at randomization. This is measured with a portable blood pressure monitor (ABPM). People must be active by day and sleep at night.
- Biomarker or test result
- Average systolic blood pressure while asleep of 120 mmHg or more, measured by ABPM.
Main reasons for not taking part
- Pregnancy, or drug or alcohol abuse in the last two years.
- Night work or shift work, or unable to tolerate the portable blood pressure monitor (ABPM).
- High blood pressure caused by another disease, such as narrowing of the aorta or kidney artery, hyperaldosteronism or pheochromocytoma.
- Unstable angina, heart failure, life-threatening heart rhythm problems, atrial fibrillation, kidney failure or grade III-IV retinopathy. Past heart events are allowed if full physical and work activity continues.
- Cancer (except basal cell skin cancer) or another severe, life-threatening disease in the past five years, a systemic autoimmune disease, or AIDS.
Read by machine on 12 November 2026.
Where in Spain
- CS A EstradaA Estrada, SpainContact: Juan J Sánchez Castro, MDTaking people
- CS PanxónNigrán, SpainContact: Jose L Salgado, MDTaking people
- Complexo Hospitalario Universitario de OurenseOurense, SpainContact: Alfonso Otero, MD, PhDTaking people
- Bioengineering & Chronobilogy Labs., University of VigoVigo, SpainContact: Ramon C Hermida, PhDTaking people
- Centro de Salud de A DobladaVigo, SpainContact: María T Ríos, MD, PhDTaking people
- Centro de Salud de BembriveVigo, SpainContact: Juan J Crespo Sabarís, MD, PhDTaking people
- Centro de Salud de SardomaVigo, SpainContact: Manuel Domínguez-Sardiña, MD, PhDTaking people
- CS TeisVigo, SpainTaking people
- CS San RoqueVilagarcía de Arousa, SpainContact: Envira Sineiro, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Vigo
- Trial code
- NCT03457168
- Record updated
- 6 December 2024
- Original description
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 SPRINT trial, the recent 2017 guidelines of the American College of Cardiology (ACC) and the American Heart Association (AHA) have established lower values of 130/80 mmHg for clinic systolic BP (SBP)/diastolic BP (DBP) as new diagnostic thresholds for hypertension and therapeutic targets for treatment of all individuals aged ≥18 years regardless of age, sex, or concomitant complications including presence of diabetes, chronic kidney disease (CKD), or history of past CVD event. According to these guidelines, the new proposed ambulatory BP measurment (ABPM) thresholds for diagnosis of hypertension in adults are 130/80 and 110/65 mmHg for the awake and asleep SBP/DBP means, respectively. However, the ACC/AHA guidelines do not provide any scientific evidence documenting neither the equivalence between these ABPM thresholds and the 130/80 mmHg cut-off values for OBPM nor the potential improved CVD event-free survival time of the proposed more intensive control of ambulatory BP.Read full original descriptionShow less
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
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 SPRINT trial, the recent 2017 guidelines of the American College of Cardiology (ACC) and the American Heart Association (AHA) have established lower values of 130/80 mmHg for clinic systolic BP (SBP)/diastolic BP (DBP) as new diagnostic thresholds for hypertension and therapeutic targets for treatment of all individuals aged ≥18 years regardless of age, sex, or concomitant complications including presence of diabetes, chronic kidney disease (CKD), or history of past CVD event. According to these guidelines, the new proposed ambulatory BP measurment (ABPM) thresholds for diagnosis of hypertension in adults are 130/80 and 110/65 mmHg for the awake and asleep SBP/DBP means, respectively. However, the ACC/AHA guidelines do not provide any scientific evidence documenting neither the equivalence between these ABPM thresholds and the 130/80 mmHg cut-off values for OBPM nor the potential improved CVD event-free survival time of the proposed more intensive control of ambulatory BP.
Results derived from observational prospective studies consistently document that therapeutic BP targets in hypertensive individuals, i.e., persons at increased CVD risk, should be established in terms of proper control of asleep BP. To date, no prospective randomized study has ever before evaluated which should be the adequate therapeutic ABPM target for most effective reduction of CVD risk. Accordingly, the Tratamiento de Hipertensión Arterial Durante el Sueño study (THADEUS, i.e., Treatment of Hypertension During Sleep) has been designed to prospectively evaluate if "intensive control" of asleep SBP mean proposed by the new ACC/AHA guidelines (<110 mmHg) in more effective than the so far its "conventional control" (<120 mmHg) to reduce CVD morbidity and mortality in hypertensive individuals.
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: Previous history of a systemic autoimmune disease or AIDS; 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; History of drug/alcohol abuse within the last two years; Evidence of a secondary form of hypertension, including coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma; 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; Pregnancy; Night/shift-work employment; Inability to communicate and comply with all study requirements; Intolerance to ABPM.