Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD

  • STATUS
    Recruiting
  • End date
    Jul 25, 2026
  • participants needed
    200
  • sponsor
    University of California, San Francisco
Updated on 25 January 2021
hypertension
systolic blood pressure
renal failure
nephropathy
cardiovascular morbidity

Summary

The transition from chronic kidney disease (CKD) to end-stage renal disease ESRD is a vulnerable and challenging period of time for patients and providers. Suboptimal control of blood pressure is known to be common in patients with the advanced stages of CKD, and may contribute to their elevated risk of progression to ESRD, cardiovascular morbidity, and mortality. This proposal is a pilot randomized controlled trial designed to test whether intensive blood pressure lowering is feasible and safe in patients with advanced CKD as they transition to ESRD.

Description

The transition from advanced chronic kidney disease (CKD), when estimated glomerular filtration rate (eGFR) is <30 mL/min/1.73m2, to end-stage renal disease (ESRD) represents a vulnerable period, when multiple physiologic and psychosocial changes occur as patients prepare for either dialysis or kidney transplant. This study is a pilot randomized controlled trial to test the safety and feasibility of studying strict versus usual BP control in a population of patients with advanced CKD (eGFR <30 mL/min/1.73m2), including those with diabetes. For this pilot study, we will randomize 60 patients with advanced CKD who have elevated BP to either a home SBP target of <120 mm Hg (intervention group) versus 130-140 mm Hg (usual care group).

Details
Condition chronic renal insufficiency, Chronic renal failure, Vascular Diseases, Hypertension, Blood Pressure, Diabetes and Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric), Elevated Blood Pressure, chronic kidney disease, chronic kidney disease (ckd), high blood pressure, arterial hypertension
Treatment Strict blood pressure control
Clinical Study IdentifierNCT02975505
SponsorUniversity of California, San Francisco
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 16 yrs?
Gender: Male or Female
Do you have any of these conditions: Chronic renal failure or Diabetes and Hypertension or Hypertension or Vascular Diseases or High Blood Pressure (Hypertension) or Blood Pressure or Hig...?
Do you have any of these conditions: chronic renal insufficiency or Blood Pressure or chronic kidney disease (ckd) or Elevated Blood Pressure or Chronic renal failure or arterial hyperten...?
Adults 16 years of age who meet the eGFR eligibility criteria, which will be
determined based on whether participants have
at least two eGFR in the last three months that are <30 mL/min/1.73m2 or
prior diagnosis of CKD (per electronic chart review) and at least one eGFR <30 mL/min/1.73m2
history of hypertension
mid-arm circumference between 22-37cm (BP cuff size limitation) and be able to provide consent to participate in our study

Exclusion Criteria

Those who
are or are planning to become pregnant, due to inability to take multiple classes of anti-hypertensive agents
are marginally housed, due to concerns regarding routine follow-up
are actively participating in a different interventional trial that may affect blood pressure
are unwilling to consent to participate
institutionalized individuals or prisoners
are actively abusing illicit drugs or alcohol
have a history of poor or doubtful compliance (e.g., frequently missed appointments)
have office SBP >170 mmHg
are already taking 5 anti-hypertensive medications (any classes, including diuretics) have cognitive impairment prohibiting participation in the study
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