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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
CS A Estrada
RECRUITING
A Estrada
CS Panxón
RECRUITING
Nigrán
Complexo Hospitalario Universitario de Ourense
RECRUITING
Ourense
Bioengineering & Chronobilogy Labs., University of Vigo
RECRUITING
Vigo
Centro de Salud de A Doblada
RECRUITING
Vigo
Centro de Salud de Bembrive
RECRUITING
Vigo
Centro de Salud de Sardoma
RECRUITING
Vigo
CS Teis
RECRUITING
Vigo
CS San Roque
RECRUITING
Vilagarcía De Arousa
Contact Information
Primary
Ramon C Hermida, PhD
rhermida@uvigo.es
34986812148
Backup
José R Fernández, PhD
jramon.fernandez@uvigo.es
34986812146
Time Frame
Start Date: 2019-02-01
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 5320
Treatments
Active_comparator: Intensive asleep SBP control
To reduce the asleep SBP mean up to a target \<110 mmHg. Treatment of elevated asleep SBP mean
Active_comparator: Conventional asleep SBP control
To reduce the asleep SBP mean up to a target \<120 mmHg. Treatment of elevated asleep SBP mean
Related Therapeutic Areas
Sponsors
Leads: University of Vigo

This content was sourced from clinicaltrials.gov