Managing blood pressure in Veterans with chronic kidney disease
Pharmacist-guided, Patient-driven Management of High Blood Pressure in CKD: A Novel Approach
This study is testing if Veterans with chronic kidney disease can better manage their blood pressure with help from a clinical pharmacist compared to regular care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT05546099 on ClinicalTrials.gov |
What this trial studies
This research evaluates whether Veterans with chronic kidney disease (CKD) can effectively manage their blood pressure medications with guidance from a clinical pharmacist, compared to standard care. The study will involve 60 Veterans who will monitor their blood pressure at home and follow a pre-determined medication titration plan. The goal is to enhance patient engagement and improve blood pressure control, ultimately aiming to reduce the risks associated with CKD and cardiovascular disease. Factors influencing the acceptance of this self-management approach and its implementation within the Veterans Health Administration will also be assessed.
Who should consider this trial
Good fit: Ideal candidates are Veterans aged 18 and older with stage 2 to 4 chronic kidney disease and uncontrolled hypertension.
Not a fit: Patients with severely uncontrolled hypertension, resistant hypertension, or severe cognitive decline may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better blood pressure control and improved health outcomes for Veterans with chronic kidney disease.
How similar studies have performed: While this specific approach has not been tested, preliminary data suggest that pharmacist-guided self-management can be effective in similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>= 18 years, * CKD stage 3 or 4 (estimated GFR: 15-59 mL/min/1.73m2) or * Stage 2 CKD (estimated GFR 60-89 mL/min/1.73m2) with urinary albumin/creatinine ratio (ACR 300 mg/g if no DM and 30 mg/g if with DM), and * Uncontrolled hypertension defined as the avg of 2 readings \> 140 systolic. Exclusion Criteria: * Severely uncontrolled hypertension defined as systolic BP \>180, * Patients with resistant hypertension and taking 4 BP medications, * Orthostatic hypotension defined as reduced systolic BP by 20 mmHg or diastolic BP by 10 mmHg after 3 minutes of standing, * Severe CKD defined as estimated GFR \< 20 mL/min/1.73m2, * Life expectancy \<1 year, * Severe liver disease, * Severe congestive heart failure, * Severe cognitive decline due to dementia, * Pregnant, breastfeeding, or unwilling to use adequate birth control
Where this trial is running
Iowa City, Iowa
- Iowa City VA Health Care System, Iowa City, IA — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Diana Jalal, MD — Iowa City VA Health Care System, Iowa City, IA
- Study coordinator: Diana Jalal, MD
- Email: diana.jalal@va.gov
- Phone: (319) 338-0581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.