Status:
COMPLETED
Sleep-time Blood Pressure and Risk of CKD Progression
Lead Sponsor:
University of Vigo
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Servicio Gallego de Salud
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
Brief Summary
The SLEEP-BP-CKD Study has been designed to specifically test the following primary hypotheses: (i) Specific ABPM-derived parameters, in particular the asleep SBP mean and/or the sleep-time relative ...
Detailed Description
Hypertension is very common in patients with chronic kidney disease (CKD); its prevalence increases with diminished estimated glomerular filtration rate (eGFR), reaching an estimated 86% in patients w...
Eligibility Criteria
Inclusion
- Men and women aged ≥18 years.
- Wrist circumference between 13.5 and 21.5 cm to enable proper use of the NightView HBPM device (only for those who might use it).
- Upon recruitment have moderate to severely decreased eGFR, i.e., stages G3b (eGFR 30-44 ml/min/1.73 m2) or G4 (eGFR 15-29 ml/min/1.73 m2).
- Agreement to adhere lifestyle considerations (routine of daytime activity and nighttime sleep) and mandates (e.g., wearing of NightView and ABPM devices) of the investigative protocol.
- Provision of written informed consent to participate into the study.
Exclusion
- Pregnancy.
- History of alcoholism or narcotic addiction within the last two years.
- Night, rotating shift-work employment, or frequent transmeridian travel.
- 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.
- Severe cardiac disease (unstable angina pectoris, unstable heart failure, life-threatening arrhythmia, and atrial fibrillation). Previous CVD events will not be exclusionary if full physical and work activities are maintained.
- Any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any medication, or, at the discretion of the investigator, might place the subject at higher medical risk from his/her participation in the study, or is likely to prevent the subject from complying with the requirements of the study or completing the trial period.
- History of any malignancy within the past five years, including leukemia and lymphoma (but not basal cell skin cancer), or any other severe disease if involving life-threatening risk.
- Inability to communicate and comply with all study requirements.
- Intolerance to or unacceptance of ABPM or HBPM.
Key Trial Info
Start Date :
May 11 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT05189418
Start Date
May 11 2022
End Date
December 31 2024
Last Update
March 5 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
CS A Estrada
A Estrada, Pontevedra, Spain, 26680
2
Centro de Salud de A Doblada
Vigo, Pontevedra, Spain, 36205
3
Policlinico Vigo SA - POVISA
Vigo, Pontevedra, Spain, 36211
4
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain, 36213