Sleep-time Blood Pressure and Risk of CKD Progression

NCT05189418 | Completed DMC

• 3 other identifiers: SLEEP-BP-CKD2021-002585-412021/451
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 10

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 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.

Conditions

Chronic Kidney Diseases

Keywords

Ambulatory blood pressure monitoring; Home blood pressure monitoring; Chronic kidney disease; Cardiovascular risk; Sleep-time blood pressure; Blood pressure dipping

Outcome Measures

Primary Outcomes (3)

• CKD-progression

  Composite of 30% decrease in eGFR, 30% increase in albuminuria, or ESKD

  2 years

• CVD-outcome

  Composite of CVD death, myocardial infarction, coronary revascularization, heart failure, ischemic stroke, and hemorrhagic stroke.

  2 years

• Renal+CVD-outcome

  Composite of 30% decrease in eGFR, 30% increase in albuminuria, ESKD, all-cause mortality, or major CVD event

  2 years

Secondary Outcomes (5)

• Coronary events

  2 years

• Cardiac events

  2 years

• Stroke

  2 years

• Total CVD events

  2 years

• Minor CVD events

  2 years

Interventions

Ambulatory blood pressure monitoring (ABPM) DEVICE

Periodic (quarterly) 48h ABPM evaluation during follow-up

Home blood pressure monitoring (HBPM) DEVICE

Periodic (monthly) 7-day HBPM, both during awake and sleep spans, during follow-up

Eligibility Criteria

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

Study Population

Patients who 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Vigo: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Servicio Gallego de Salud: collaborator
• University of Texas at Austin: collaborator
• University of California, Los Angeles: collaborator

Study Sites (10)

CS A Estrada

A Estrada, Pontevedra, 26680, Spain

Location

Centro de Salud de A Doblada

Vigo, Pontevedra, 36205, Spain

Location

Policlinico Vigo SA - POVISA

Vigo, Pontevedra, 36211, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, 36213, Spain

Location

Centro de Salud de Bembrive

Vigo, Pontevedra, 36214, Spain

Location

Centro de Salud de Lavadores

Vigo, Pontevedra, 36214, Spain

Location

Centro de Salud de Sardoma

Vigo, Pontevedra, 36214, Spain

Location

CS Teis

Vigo, Pontevedra, 36216, Spain

Location

Bioengineering & Chronobilogy Labs., University of Vigo

Vigo, Pontevedra, 36310, Spain

Location

CS San Roque

Vilagarcía de Arousa, Pontevedra, 36600, Spain

Location

Related Publications (15)

• Asayama K, Fujiwara T, Hoshide S, Ohkubo T, Kario K, Stergiou GS, Parati G, White WB, Weber MA, Imai Y; International Expert Group of Nocturnal Home Blood Pressure. Nocturnal blood pressure measured by home devices: evidence and perspective for clinical application. J Hypertens. 2019 May;37(5):905-916. doi: 10.1097/HJH.0000000000001987.

  PMID: 30394982 BACKGROUND

• Cheng D, Tang Y, Li H, Li Y, Sang H. Nighttime blood pressure decline as a predictor of renal injury in patients with hypertension: a population-based cohort study. Aging (Albany NY). 2019 Jul 5;11(13):4310-4322. doi: 10.18632/aging.101873.

  PMID: 31276448 BACKGROUND

• Coresh J, Turin TC, Matsushita K, Sang Y, Ballew SH, Appel LJ, Arima H, Chadban SJ, Cirillo M, Djurdjev O, Green JA, Heine GH, Inker LA, Irie F, Ishani A, Ix JH, Kovesdy CP, Marks A, Ohkubo T, Shalev V, Shankar A, Wen CP, de Jong PE, Iseki K, Stengel B, Gansevoort RT, Levey AS. Decline in estimated glomerular filtration rate and subsequent risk of end-stage renal disease and mortality. JAMA. 2014 Jun 25;311(24):2518-2531. doi: 10.1001/jama.2014.6634.

  PMID: 24892770 BACKGROUND

• Coresh J, Heerspink HJL, Sang Y, Matsushita K, Arnlov J, Astor BC, Black C, Brunskill NJ, Carrero JJ, Feldman HI, Fox CS, Inker LA, Ishani A, Ito S, Jassal S, Konta T, Polkinghorne K, Romundstad S, Solbu MD, Stempniewicz N, Stengel B, Tonelli M, Umesawa M, Waikar SS, Wen CP, Wetzels JFM, Woodward M, Grams ME, Kovesdy CP, Levey AS, Gansevoort RT; Chronic Kidney Disease Prognosis Consortium and Chronic Kidney Disease Epidemiology Collaboration. Change in albuminuria and subsequent risk of end-stage kidney disease: an individual participant-level consortium meta-analysis of observational studies. Lancet Diabetes Endocrinol. 2019 Feb;7(2):115-127. doi: 10.1016/S2213-8587(18)30313-9. Epub 2019 Jan 8.

  PMID: 30635225 BACKGROUND

• Gabbai FB, Rahman M, Hu B, Appel LJ, Charleston J, Contreras G, Faulkner ML, Hiremath L, Jamerson KA, Lea JP, Lipkowitz MS, Pogue VA, Rostand SG, Smogorzewski MJ, Wright JT, Greene T, Gassman J, Wang X, Phillips RA; African American Study of Kidney Disease and Hypertension (AASK) Study Group. Relationship between ambulatory BP and clinical outcomes in patients with hypertensive CKD. Clin J Am Soc Nephrol. 2012 Nov;7(11):1770-6. doi: 10.2215/CJN.11301111. Epub 2012 Aug 30.

  PMID: 22935847 BACKGROUND

• International Society for Chronobiology; American Association of Medical Chronobiology and Chronotherapeutics; Spanish Society of Applied Chronobiology, Chronotherapy, and Vascular Risk; Spanish Society of Atherosclerosis; Romanian Society of Internal Medicine; Hermida RC, Smolensky MH, Ayala DE, Portaluppi F. 2013 ambulatory blood pressure monitoring recommendations for the diagnosis of adult hypertension, assessment of cardiovascular and other hypertension-associated risk, and attainment of therapeutic goals. Chronobiol Int. 2013 Apr;30(3):355-410. doi: 10.3109/07420528.2013.750490.

  PMID: 23517220 BACKGROUND

• Hermida RC, Ayala DE, Mojon A, Fernandez JR. Sleep-Time Ambulatory BP Is an Independent Prognostic Marker of CKD. J Am Soc Nephrol. 2017 Sep;28(9):2802-2811. doi: 10.1681/ASN.2016111186. Epub 2017 Apr 28.

  PMID: 28455314 BACKGROUND

• Hermida RC, Crespo JJ, Otero A, Dominguez-Sardina M, Moya A, Rios MT, Castineira MC, Callejas PA, Pousa L, Sineiro E, Salgado JL, Duran C, Sanchez JJ, Fernandez JR, Mojon A, Ayala DE; Hygia Project Investigators. Asleep blood pressure: significant prognostic marker of vascular risk and therapeutic target for prevention. Eur Heart J. 2018 Dec 14;39(47):4159-4171. doi: 10.1093/eurheartj/ehy475.

  PMID: 30107515 BACKGROUND

• Ida T, Kusaba T, Kado H, Taniguchi T, Hatta T, Matoba S, Tamagaki K. Ambulatory blood pressure monitoring-based analysis of long-term outcomes for kidney disease progression. Sci Rep. 2019 Dec 17;9(1):19296. doi: 10.1038/s41598-019-55732-4.

  PMID: 31848394 BACKGROUND

• Kanno A, Kikuya M, Asayama K, Satoh M, Inoue R, Hosaka M, Metoki H, Obara T, Hoshi H, Totsune K, Sato T, Taguma Y, Sato H, Imai Y, Ohkubo T. Night-time blood pressure is associated with the development of chronic kidney disease in a general population: the Ohasama Study. J Hypertens. 2013 Dec;31(12):2410-7. doi: 10.1097/HJH.0b013e328364dd0f.

  PMID: 24029869 BACKGROUND

• Minutolo R, Agarwal R, Borrelli S, Chiodini P, Bellizzi V, Nappi F, Cianciaruso B, Zamboli P, Conte G, Gabbai FB, De Nicola L. Prognostic role of ambulatory blood pressure measurement in patients with nondialysis chronic kidney disease. Arch Intern Med. 2011 Jun 27;171(12):1090-8. doi: 10.1001/archinternmed.2011.230.

  PMID: 21709109 BACKGROUND

• Mojon A, Ayala DE, Pineiro L, Otero A, Crespo JJ, Moya A, Boveda J, de Lis JP, Fernandez JR, Hermida RC; Hygia Project Investigators. Comparison of ambulatory blood pressure parameters of hypertensive patients with and without chronic kidney disease. Chronobiol Int. 2013 Mar;30(1-2):145-58. doi: 10.3109/07420528.2012.703083. Epub 2012 Oct 25.

  PMID: 23181690 BACKGROUND

• Rahman M, Wang X, Bundy JD, Charleston J, Cohen D, Cohen J, Drawz PE, Ghazi L, Horowitz E, Lash JP, Schrauben S, Weir MR, Xie D, Townsend RR; CRIC Study Investigators. Prognostic Significance of Ambulatory BP Monitoring in CKD: A Report from the Chronic Renal Insufficiency Cohort (CRIC) Study. J Am Soc Nephrol. 2020 Nov;31(11):2609-2621. doi: 10.1681/ASN.2020030236. Epub 2020 Sep 24.

  PMID: 32973085 BACKGROUND

• Stergiou GS, Palatini P, Parati G, O'Brien E, Januszewicz A, Lurbe E, Persu A, Mancia G, Kreutz R; European Society of Hypertension Council and the European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. 2021 European Society of Hypertension practice guidelines for office and out-of-office blood pressure measurement. J Hypertens. 2021 Jul 1;39(7):1293-1302. doi: 10.1097/HJH.0000000000002843. No abstract available.

  PMID: 33710173 BACKGROUND

• Wang C, Zhang J, Liu X, Li C, Ye Z, Peng H, Chen Z, Lou T. Reversed dipper blood-pressure pattern is closely related to severe renal and cardiovascular damage in patients with chronic kidney disease. PLoS One. 2013;8(2):e55419. doi: 10.1371/journal.pone.0055419. Epub 2013 Feb 5.

  PMID: 23393577 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Ramon C Hermida, PhD

  University of Vigo

  PRINCIPAL INVESTIGATOR

• Michael H Smolensky, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Sherine El-Toukhy, PhD

  National Institute on Minority Health and Health Disparities (NIMHD)

  PRINCIPAL INVESTIGATOR

• Keith C Norris, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Director of Bioengineering & Chronobiology Labs

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 12, 2022
• Study Start: May 11, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

ES (10)