Treatment of Hypertension During Sleep

NCT03457168 | Recruiting DMC

• 3 other identifiers: THADEUS2017-001410-282017/470
• Study Type: interventional
• Target: 5,320
• Locations: 1 country
• Sites: 9

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.

Conditions

Hypertension; Hypertension, Systolic

Keywords

Sleep-time hypertension; Ambulatory blood pressure monitoring; Hypertension chronotherapy; Asleep blood pressure; Cardiovascular risk; Type 2 diabetes; Chronic kidney disease

Outcome Measures

Primary Outcomes (3)

• Vascular events

  Rate of cardiovascular events and stroke

  Median follow-up of 5 years

• New-onset type 2 diabetes

  Development of type 2 diabetes

  Median follow-up of 5 years

• New-onset CKD

  Development of chronic kidney disease

  Median follow-up of 5 years

Secondary Outcomes (2)

• Coronary events

  Median follow-up of 5 years

• Cardiac events

  Median follow-up of 5 years

Study Arms (2)

Intensive asleep SBP control

ACTIVE COMPARATOR

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

Conventional asleep SBP control

ACTIVE COMPARATOR

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

Interventions

Treatment of elevated asleep SBP mean PROCEDURE

To reduce asleep SBP mean determined by 48h ambulatory blood pressure monitoring up to the randomly assigned target by hypertension treatment intensification when required

Conventional asleep SBP control; Intensive asleep SBP control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Vigo: lead

Study Sites (9)

Complexo Hospitalario Universitario de Ourense

Ourense, Orense, 32005, Spain

RECRUITING

CS A Estrada

A Estrada, Pontevedra, 26680, Spain

RECRUITING

CS Panxón

Nigrán, Pontevedra, 36340, Spain

RECRUITING

Centro de Salud de A Doblada

Vigo, Pontevedra, 36205, Spain

RECRUITING

Centro de Salud de Bembrive

Vigo, Pontevedra, 36214, Spain

RECRUITING

Centro de Salud de Sardoma

Vigo, Pontevedra, 36214, Spain

RECRUITING

CS Teis

Vigo, Pontevedra, 36216, Spain

RECRUITING

Bioengineering & Chronobilogy Labs., University of Vigo

Vigo, Pontevedra, 36310, Spain

RECRUITING

CS San Roque

Vilagarcía de Arousa, Pontevedra, 36600, Spain

RECRUITING

MeSH Terms

Conditions

Hypertension; Isolated Systolic Hypertension; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Essential Hypertension; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ramon C Hermida, PhD

  University of Vigo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramon C Hermida, PhD

CONTACT

34986812148; rhermida@uvigo.es

José R Fernández, PhD

CONTACT

34986812146; jramon.fernandez@uvigo.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants unaware of their assigned randomized group. Outcomes evaluated by an independent Events Committee.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Bioengineering & Chronobiology Labs.

Model Details: Prospective, randomized, open-label (for medication treatment), two-arms, blinded-endpoint clinical trial.

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: March 7, 2018
• Study Start: February 1, 2019
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2032
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

ES (9)