NCT05189418Completed
Sleep-time Blood Pressure and Risk of CKD Progression
Sleep-time Blood Pressure Determined by Home and Ambulatory Monitoring as Potential Prognostic Factor for Chronic Kidney Disease (CKD) Progression, Mortality, and Cardiovascular Morbidity in Patients With Advanced CKD
Source: ClinicalTrials.gov · Last updated 5 Mar 2025
Brief summary (registry, in English)
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 SBP decline, are significant prognostic markers of deterioration of kidney function and progression towards ESKD, as well as of the risk of all-cause mortality and major CVD events, in high-risk patients with stage G3b-G4 CKD. (ii) Changes during follow-up in specific ABPM-derived parameters, in particular the increase of the asleep SBP mean and/or decrease of the sleep-time relative SBP decline towards the non-dipper/riser 24h SBP pattern, are significant prognostic markers of deterioration of kidney function and progression towards ESKD, as well as of the risk of all-cause mortality and major CVD events, in high-risk patients with stage G3b-G4 CKD. A novelty of the SLEEP-BP-CKD Study is the incorporation of clinical-grade wearable digital technology to monitor both wake-time and sleep-time BP at home in a subgroup (up to 200) of the total sample; this procedure will provide added useful information to test the following additional hypotheses: (iii) The HBPM self-assessment procedure to obtain BP measurements both during wake-time and sleep-time spans provides reliable data to be used either individually or jointly with periodic ABPM as added potential prognostic marker of deterioration of kidney function and progression towards ESKD, as well as of the risk of all-cause mortality and major CVD events, in high-risk patients with stage G3b-G4 CKD. (iv) The sleep-time BP measurements obtained by HBPM self-assessment and their changes during follow-up are better correlated, compared with wake-time OBPM or wake-time HBPM, to eGFR and albuminuria (measured by the albumin/creatinine ratio) and their changes during follow-up, respectively. (v) The HBPM self-assessment procedure to obtain BP measurements both during wake-time and sleep-time spans increases patient adherence/compliance to prescribed treatment from baseline. The scheduled periodic patient BP assessments during follow-up with OBPM, HBPM, 48h ABPM, along with laboratory urine and blood test data will further allow evaluating and comparing the changes from baseline in all these clinically relevant variables as potential markers for risk of progression towards ESKD, all-cause mortality, and/or CVD morbidity.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 210 (actual)
- First submitted
- 23 Dec 2021
- Start date
- 11 May 2022
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- University of Vigo
- Diseases
- Chronic kidney disease
- NCT number
- NCT05189418
- EudraCT number
- 2021-002585-41
What you commit to
- Study type: Observational
- Participants enrolled: 210
- From 11 May 2022 to the primary completion date, 31 Dec 2024
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of a systemic autoimmune disease or AIDS.
- 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.
Other illness
- History of alcoholism or narcotic addiction within the last two years.
- 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 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.
Other
- Pregnancy.
- Night, rotating shift-work employment, or frequent transmeridian travel.
- Inability to communicate and comply with all study requirements.
- Intolerance to or unacceptance of ABPM or HBPM.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CS A Estrada Coordinator of this site? Confirm its status | A Estrada | Spain | Unknown status |
| Centro de Salud de Bembrive Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Policlinico Vigo SA - POVISA Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Bioengineering & Chronobilogy Labs., University of Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Centro de Salud de Lavadores Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Centro de Salud de A Doblada Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Centro de Salud de Sardoma Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| CS Teis Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| CS San Roque Coordinator of this site? Confirm its status | Vilagarcía de Arousa | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.