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

Detailed 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.

Study Details

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Interventions