Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03457168 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Treatment of Hypertension During Sleep

Study acronym: THADEUS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date: Dec 2031 to Dec 31, 2031
    • Study completion date: Dec 2032 to Dec 31, 2032
    • Site details revised at 9 of 9 sites
    v9
  2. Notable Primary completion date: Mar 2031 to Dec 2031
    • Study completion date: Mar 2031 to Dec 2032
    v8
  3. Minor 3 versions Re-verified since Jan 10, 2020, no change to tracked fieldsv5-v7
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 2030 to Mar 2031
    • Start date changed from estimate of Dec 2018 to Feb 1, 2019
    • Site details revised at 9 of 9 sites
    v4
  5. Notable Start date: Sep 2018 to Dec 2018v3
  6. Notable Start date: May 2018 to Sep 2018v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
5,087 trials monitored
See 222 trials at risk
2,231 trials monitored
See 111 trials at risk
1,925 trials monitored
See 99 trials at risk
and 1 more disease
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.
Trial Details
NCT Number NCT03457168
Lead Sponsor University of Vigo
Conditions
(from sponsor)
Hypertension, Hypertension, Systolic
Related terms Diabetes Mellitus, Type 2, Hypertension, Isolated Systolic Hypertension, Renal Insufficiency, Chronic
Enrollment 5,320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov