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
Acronym: THADEUS
ClinicalTrials.gov ID: NCT03457168
Organization: University of Vigo
Status: RECRUITING
Study type: INTERVENTIONAL
Phases: NA
Conditions: Hypertension
Hypertension, Systolic
Interventions: PROCEDURE: Treatment of elevated asleep SBP mean
Lead sponsor: University of Vigo (OTHER)
Enrollment: 5320 participants
Eligibility: sex ALL, minimum age 18 Years, maximum age 
Accepts healthy volunteers: no
Start date: 2019-02-01
Completion date: 2032-12-31
Locations:
facility: Complexo Hospitalario Universitario de Ourense
city: Ourense
state: Orense
country: Spain
facility: CS A Estrada
city: A Estrada
state: Pontevedra
country: Spain
facility: CS Panxón
city: Nigrán
state: Pontevedra
country: Spain
facility: Centro de Salud de A Doblada
city: Vigo
state: Pontevedra
country: Spain
facility: Centro de Salud de Bembrive
city: Vigo
state: Pontevedra
country: Spain
facility: Centro de Salud de Sardoma
city: Vigo
state: Pontevedra
country: Spain
facility: CS Teis
city: Vigo
state: Pontevedra
country: Spain
facility: Bioengineering & Chronobilogy Labs., University of Vigo
city: Vigo
state: Pontevedra
country: Spain
facility: CS San Roque
city: Vilagarcía de Arousa
state: Pontevedra
country: Spain

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 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.