Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Hypertension During Sleep (THADEUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03457168
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ramon C. Hermida, University of Vigo

Brief 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.


Condition or disease Intervention/treatment Phase
Hypertension Hypertension, Systolic Procedure: Treatment of elevated asleep SBP mean Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, open-label (for medication treatment), two-arms, blinded-endpoint clinical trial.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants unaware of their assigned randomized group. Outcomes evaluated by an independent Events Committee.
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : March 2031
Estimated Study Completion Date : March 2031

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intensive asleep SBP control
To reduce the asleep SBP mean up to a target <110 mmHg. Treatment of elevated asleep SBP mean
Procedure: Treatment of elevated asleep SBP mean
To reduce asleep SBP mean determined by 48h ambulatory blood pressure monitoring up to the randomly assigned target by hypertension treatment intensification when required

Active Comparator: Conventional asleep SBP control
To reduce the asleep SBP mean up to a target <120 mmHg. Treatment of elevated asleep SBP mean
Procedure: Treatment of elevated asleep SBP mean
To reduce asleep SBP mean determined by 48h ambulatory blood pressure monitoring up to the randomly assigned target by hypertension treatment intensification when required




Primary Outcome Measures :
  1. Vascular events [ Time Frame: Median follow-up of 5 years ]
    Rate of cardiovascular events and stroke

  2. New-onset type 2 diabetes [ Time Frame: Median follow-up of 5 years ]
    Development of type 2 diabetes

  3. New-onset CKD [ Time Frame: Median follow-up of 5 years ]
    Development of chronic kidney disease


Secondary Outcome Measures :
  1. Coronary events [ Time Frame: Median follow-up of 5 years ]
    Rate of coronary events registered during follow-up

  2. Cardiac events [ Time Frame: Median follow-up of 5 years ]
    Rate of cardiac events registered during follow-up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women aged ≥18 years.
  2. 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:

  1. Pregnancy.
  2. History of drug/alcohol abuse within the last two years.
  3. Night/shift-work employment.
  4. Previous history of a systemic autoimmune disease or AIDS.
  5. Evidence of a secondary form of hypertension, including coarctation of the aorta, hyperaldosteronism, renal artery stenosis, or pheochromocytoma
  6. 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.
  7. 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.
  8. 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.
  9. Inability to communicate and comply with all study requirements.
  10. Intolerance to ABPM.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457168


Contacts
Layout table for location contacts
Contact: Ramon C Hermida, PhD 34986812148 rhermida@uvigo.es
Contact: José R Fernández, PhD 34986812146 jramon.fernandez@uvigo.es

Locations
Layout table for location information
Spain
CS A Estrada Recruiting
La Estrada, Pontevedra, Spain, 26680
Contact: Juan J Sánchez Castro, MD    34986573459    juanjose.sanchez.castro@sergas.es   
Principal Investigator: Juan J Sanchez Castro, MD         
Sub-Investigator: Mariana Carbon, MD         
Sub-Investigator: Maria C Garcia, MD         
Sub-Investigator: Francisco Romero, MD         
Sub-Investigator: Maria P Brea         
CS Panxón Recruiting
Nigrán, Pontevedra, Spain, 36340
Contact: Jose L Salgado, MD    34986368615    joseluis.salgado.conde@sergas.es   
Principal Investigator: Jose L Salgado, MD         
Sub-Investigator: Esperanza Parrado         
Sub-Investigator: Alfredo Pereira         
Centro de Salud de A Doblada Recruiting
Vigo, Pontevedra, Spain, 36205
Contact: María T Ríos, MD, PhD    34986275121    rios.rey@mundo-r.com   
Principal Investigator: María T Ríos, MD, PhD         
Centro de Salud de Bembrive Recruiting
Vigo, Pontevedra, Spain, 36214
Contact: Juan J Crespo Sabarís, MD, PhD    34986424636    juanjose.crespo.sabaris@sergas.es   
Principal Investigator: Juan J Crespo Sabaría, MD, PhD         
Centro de Salud de Sardoma Recruiting
Vigo, Pontevedra, Spain, 36214
Contact: Manuel Domínguez-Sardiña, MD, PhD    34986416324    manuel.dominguez.sardina@sergas.es   
Principal Investigator: Manuel Domínguez, MD, PhD         
CS Teis Recruiting
Vigo, Pontevedra, Spain, 36216
Contact: Pedro A Callejas, MD    34986374229    PedroAntonio.Callejas.Cabanillas@sergas.es   
Principal Investigator: Pedro A Callejas, MD         
Bioengineering & Chronobilogy Labs., University of Vigo Recruiting
Vigo, Pontevedra, Spain, 36310
Contact: Ramon C Hermida, PhD    34986812148    rhermida@uvigo.es   
Principal Investigator: Ramon C Hermida, PhD         
Sub-Investigator: Artemio Mojon, PhD         
Sub-Investigator: Jose R Fernandez, PhD         
Sub-Investigator: Maria J Fontao, PhD         
CS San Roque Recruiting
Vilagarcía De Arousa, Pontevedra, Spain, 36600
Contact: Envira Sineiro, MD    34986507448    Elvira.Sineiro.Galinanes@sergas.es   
Principal Investigator: Elvira Sineiro, MD         
Sub-Investigator: Margarita Alvariño         
Sub-Investigator: Luis M Fontenla         
Sub-Investigator: Margarita Fraga, MD         
Sub-Investigator: Barbara Llovo         
Sub-Investigator: Rita Martinez         
Sub-Investigator: Santiago Santidrian, MD         
Complexo Hospitalario Universitario de Ourense Recruiting
Orense, Spain, 32005
Contact: Alfonso Otero, MD, PhD    34988385625    Alfonso.Otero.Gonzalez@sergas.es   
Principal Investigator: Alfonso Otero, MD, PhD         
Sponsors and Collaborators
University of Vigo
Investigators
Layout table for investigator information
Principal Investigator: Ramon C Hermida, PhD University of Vigo

Layout table for additonal information
Responsible Party: Ramon C. Hermida, Professor and Director, Bioengineering & Chronobiology Labs., University of Vigo
ClinicalTrials.gov Identifier: NCT03457168     History of Changes
Other Study ID Numbers: THADEUS
2017-001410-28 ( EudraCT Number )
2017/470 ( Registry Identifier: State Committee of Ethics in Investigation of Galicia )
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ramon C. Hermida, University of Vigo:
Sleep-time hypertension
Ambulatory blood pressure monitoring
Hypertension chronotherapy
Asleep blood pressure
Cardiovascular risk
Type 2 diabetes
Chronic kidney disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases