Treatment of Hypertension During Sleep
Recruiting · NCT03457168 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Vigo
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
9 locations listed.
- Complexo Hospitalario Universitario de Ourense - Ourense, Orense, Spain
- CS A Estrada - A Estrada, Pontevedra, Spain
- CS Panxón - Nigrán, Pontevedra, Spain
- Centro de Salud de A Doblada - Vigo, Pontevedra, Spain
- Centro de Salud de Bembrive - Vigo, Pontevedra, Spain
- Centro de Salud de Sardoma - Vigo, Pontevedra, Spain
- CS Teis - Vigo, Pontevedra, Spain
- Bioengineering & Chronobilogy Labs., University of Vigo - Vigo, Pontevedra, Spain
- CS San Roque - Vilagarcía de Arousa, Pontevedra, Spain