Sleep-time Blood Pressure and Risk of CKD Progression

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

Interventions

DEVICE

Ambulatory blood pressure monitoring (ABPM)

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

DEVICE

Home blood pressure monitoring (HBPM)

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

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• Servicio Gallego de Salud

  collaborator OTHER_GOV

• University of Texas at Austin

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• University of Vigo

  lead OTHER

Principal Investigators

• Ramon C Hermida, PhD · University of Vigo

• Michael H Smolensky, PhD · University of Texas - Austin

• Sherine El-Toukhy, PhD · National Institute on Minority Health and Health Disparities (NIMHD)

• Keith C Norris, PhD · University of California, Los Angeles

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-11

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• Spain

Study Locations