Bloodpressure, Chronic Kidney Disease, Hypertension
Conditions
Brief 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 home blood pressure lowering is feasible and safe in patients with advanced CKD as they transition to ESRD.
Detailed 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 120 patients with advanced CKD who have elevated BP to either a home SBP target of \<120 mm Hg (intervention group) versus usual care (130-140 mmHg).
Interventions
Systolic Blood Pressure Target \< 120 mm Hg (measured at home)
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults ≥16 years of age who meet the eGFR eligibility criteria, which will be determined based on whether participants have 1. at least two eGFR in the last three months that are \<=30 mL/min/1.73m2 or 2. prior diagnosis of CKD (per electronic chart review) and at least one eGFR \<=30 mL/min/1.73m2 3. history of hypertension 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Achieved Clinic Systolic Blood Pressure | At month 12 | Achieved clinic SBP at month 12 |
| Difference in Clinic SBP Between the Two Arms | Months 4-12 | Incorporating achieved mean SBP data between months 4-12 |
| Hyperkalemia, Syncope, Falls, ESKD | Months 0-12 | Potassium \>=6 or self-reported syncope or falls or discharge diagnosis of acute kidney injury from emergency room or hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screening to Enrollment Ratio | From baseline entry through the end of Year 3 of study | This is the number of potential participants screened as eligible to the number who agree to enroll |
Other
| Measure | Time frame | Description |
|---|---|---|
| Difference in Achieved SBP | Between month 4 after baseline and year 4 of study | Clinic |
| Hyperkalemia, Syncope, Falls, ESKD | Between month 4 after baseline and year 4 of study | Potassium \>=6 or self-reported syncope or falls or discharge diagnosis or need of dialysis or retransplantation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual SBP Target Target Systolic Home Blood Pressure 130-140 mm Hg | 42 |
| Strict SBP Target Target Systolic Home Blood Pressure \<120 mm Hg
Strict blood pressure control: Systolic Blood Pressure Target \< 120 mm Hg (measured at home) | 66 |
| Total | 108 |
Baseline characteristics
| Characteristic | Usual SBP Target | Strict SBP Target | Total |
|---|---|---|---|
| Age, Continuous | 60 years | 53 years | 56 years |
| Baseline eGFR | 24 mL/min/1.73 m2 | 24 mL/min/1.73 m2 | 24 mL/min/1.73 m2 |
| Clinic diastolic blood pressure | 79 mmHg | 81 mmHg | 79 mmHg |
| Clinic systolic blood pressure | 135 mmHg | 135 mmHg | 135 mmHg |
| Diabetes | 14 Participants | 19 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 12 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 54 Participants | 93 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| History of acute coronary syndrome | 2 Participants | 5 Participants | 7 Participants |
| History of heart failure | 3 Participants | 4 Participants | 7 Participants |
| History of Smoking Current | 1 Participants | 2 Participants | 3 Participants |
| History of Smoking Former | 18 Participants | 27 Participants | 45 Participants |
| History of Smoking Never | 23 Participants | 37 Participants | 60 Participants |
| Insurance Medicaid | 3 Participants | 9 Participants | 12 Participants |
| Insurance Medicare | 20 Participants | 25 Participants | 45 Participants |
| Insurance Private | 19 Participants | 32 Participants | 51 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 14 Participants | 21 Participants | 35 Participants |
| Race/Ethnicity, Customized Black | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 12 Participants | 15 Participants |
| Race/Ethnicity, Customized White | 21 Participants | 26 Participants | 47 Participants |
| Sex: Female, Male Female | 18 Participants | 29 Participants | 47 Participants |
| Sex: Female, Male Male | 24 Participants | 37 Participants | 61 Participants |
| Urine protein/creatinine ratio | 1 g/g | 1 g/g | 1 g/g |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 66 | 2 / 42 |
| other Total, other adverse events | 18 / 66 | 10 / 42 |
| serious Total, serious adverse events | 30 / 66 | 22 / 42 |
Outcome results
Primary
Achieved Clinic Systolic Blood Pressure
Achieved clinic SBP at month 12
Time frame: At month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual SBP Target | Achieved Clinic Systolic Blood Pressure | 138.2 mmHg | Standard Deviation 5.3 |
| Strict SBP Target | Achieved Clinic Systolic Blood Pressure | 124.7 mmHg | Standard Deviation 3.8 |
Primary
Difference in Clinic SBP Between the Two Arms
Incorporating achieved mean SBP data between months 4-12
Time frame: Months 4-12
Population: Difference is measured between months 4-12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual SBP Target | Difference in Clinic SBP Between the Two Arms | 11.7 mmHg |
p-value: <0.0595% CI: [7.5, 16]Mixed Models Analysis
Primary
Hyperkalemia, Syncope, Falls, ESKD
Potassium \>=6 or self-reported syncope or falls or discharge diagnosis of acute kidney injury from emergency room or hospitalization
Time frame: Months 0-12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Hyperkalemia | 2 Participants |
| Usual SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Syncope | 1 Participants |
| Usual SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Falls | 9 Participants |
| Usual SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Dialysis or (re)-transplant | 3 Participants |
| Strict SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Dialysis or (re)-transplant | 0 Participants |
| Strict SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Hyperkalemia | 2 Participants |
| Strict SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Falls | 7 Participants |
| Strict SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Syncope | 3 Participants |
Secondary
Screening to Enrollment Ratio
This is the number of potential participants screened as eligible to the number who agree to enroll
Time frame: From baseline entry through the end of Year 3 of study
Population: Number of participants screened to enroll 1 participant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual SBP Target | Screening to Enrollment Ratio | 108 participants |
Other Pre-specified
Difference in Achieved SBP
Clinic
Time frame: Between month 4 after baseline and year 4 of study
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Usual SBP Target | Difference in Achieved SBP | 12.5 mmHg |
p-value: 0.0595% CI: [8, 16]Mixed Models Analysis
Other Pre-specified
Hyperkalemia, Syncope, Falls, ESKD
Potassium \>=6 or self-reported syncope or falls or discharge diagnosis or need of dialysis or retransplantation
Time frame: Between month 4 after baseline and year 4 of study
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usual SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Hyperkalemia | 2 Participants |
| Usual SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Syncope | 1 Participants |
| Usual SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Falls | 11 Participants |
| Usual SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Dialysis or (re)-transplant | 14 Participants |
| Strict SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Dialysis or (re)-transplant | 4 Participants |
| Strict SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Hyperkalemia | 2 Participants |
| Strict SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Falls | 8 Participants |
| Strict SBP Target | Hyperkalemia, Syncope, Falls, ESKD | Syncope | 4 Participants |