RecruitingNot ApplicableNCT03457168

Treatment of Hypertension During Sleep

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


Sponsor

University of Vigo

Enrollment

5,320 participants

Start Date

Feb 1, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether taking blood pressure medication at bedtime (instead of in the morning) reduces nighttime blood pressure and lowers the risk of heart disease. **You may be eligible if...** - You are 18 years or older (men or women) - You have elevated blood pressure during sleep - You follow a regular daytime activity and nighttime sleep routine - You are willing to provide written informed consent **You may NOT be eligible if...** - You are pregnant - You have a history of drug or alcohol abuse in the past two years - You work night shifts - You have an autoimmune disease or AIDS - You have certain heart conditions (unstable angina, heart failure, serious arrhythmia, atrial fibrillation, kidney failure) - You have a history of cancer or another severe life-threatening illness in the past five years - You have a secondary cause of high blood pressure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURETreatment 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


Locations(9)

Complexo Hospitalario Universitario de Ourense

Ourense, Orense, Spain

CS A Estrada

A Estrada, Pontevedra, Spain

CS Panxón

Nigrán, Pontevedra, Spain

Centro de Salud de A Doblada

Vigo, Pontevedra, Spain

Centro de Salud de Bembrive

Vigo, Pontevedra, Spain

Centro de Salud de Sardoma

Vigo, Pontevedra, Spain

CS Teis

Vigo, Pontevedra, Spain

Bioengineering & Chronobilogy Labs., University of Vigo

Vigo, Pontevedra, Spain

CS San Roque

Vilagarcía de Arousa, Pontevedra, Spain

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NCT03457168


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