BridgeMD
New treatment option for Hypertension
Official title Treatment of Hypertension During Sleep
ClinicalTrials.gov ID: NCT03457168
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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
- CVD disorders (unstable angina pectoris, heart failure, life-threatening arrhythmia, atrial fibrillation, kidney failure, and grade III-IV...
See the full eligibility criteria
- 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...
- 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
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ourense, Orense, Spain
- A Estrada, Pontevedra, Spain
- Nigrán, Pontevedra, Spain
- Vigo, Pontevedra, Spain
- Vilagarcía de Arousa, Pontevedra, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ourense, Orense, Spain; A Estrada, Pontevedra, Spain; Nigrán, Pontevedra, Spain; Vigo, Pontevedra, Spain; Vilagarcía de Arousa, Pontevedra, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.