Hypertension Clinical Trial
— PERFORMANCEOfficial title:
Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
NCT number | NCT02975505 |
Other study ID # | 16-20978 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | February 10, 2017 |
Est. completion date | July 2026 |
Verified date | July 2022 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 200 |
Est. completion date | July 2026 |
Est. primary completion date | July 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hyperkalemia | Hyperkalemia: This will be defined as a non-hemolyzed potassium =6.0 meq/L. | Months 1-12 and study end | |
Primary | Achieved Blood Pressure | Months 4-12 and study end | ||
Primary | Falls and syncope by self-report or based on emergency room visits | Falls and syncope: This will be defined based on self-report or if either is the chief complaint for an ER visit. | Months 1-12 and study end | |
Primary | End-stage Renal Disease | Defined as receipt of chronic dialysis or kidney transplant | Month 1 to study end | |
Secondary | Number of participants screened who enroll in trial | Feasibility of enrollment | Months 0-12 |
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