Self-Managed Blood Pressure Control for Chronic Kidney Disease

Overseen By Diana Jalal, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: VA Office of Research and Development

Disqualifiers: Severe hypertension, Severe CKD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well Veterans with chronic kidney disease (CKD) can manage their blood pressure with additional support. It compares two groups: one group manages their blood pressure medications with guidance from a pharmacist, while the other group monitors their blood pressure at home and contacts their doctor if it rises too high. The study aims to determine which approach more effectively lowers blood pressure. Veterans with CKD who have struggled to maintain their blood pressure below a certain level may be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, since the study involves managing blood pressure medications, you may need to adjust your current medications under the guidance of a clinical pharmacist.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that managing blood pressure (BP) with a clinical pharmacist's help is generally safe for people with chronic kidney disease (CKD). In a previous study, patients who adjusted their BP medications under a pharmacist's guidance experienced few serious side effects. This suggests the method is usually well-tolerated and helpful.

Regarding home BP monitoring, studies indicate that while it helps track BP, it might not improve BP control without additional support or lifestyle changes. However, it is generally safe and can be a useful tool for patients to monitor their BP levels.

Both methods appear safe for managing BP in CKD patients, with self-management demonstrating promising safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores empowering patients with chronic kidney disease to take control of their blood pressure management. Unlike traditional methods where patients rely heavily on regular doctor visits for medication adjustments, this approach allows patients to self-manage their blood pressure medications at home based on a structured plan developed with a clinical pharmacist. This self-management technique could lead to more personalized and timely adjustments, potentially improving blood pressure control and reducing complications associated with chronic kidney disease. The trial also investigates the impact of self-monitoring, where patients regularly check their blood pressure at home and proactively contact their healthcare provider if it's not within the desired range. This proactive involvement could lead to better patient outcomes by fostering a more active role in their own healthcare.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

This trial will compare two approaches for managing blood pressure in patients with chronic kidney disease (CKD). One group will self-manage blood pressure medications with guidance from a clinical pharmacist, an approach studies have shown effectively lowers blood pressure. The other group will self-monitor home blood pressure and contact their provider if it exceeds the goal. Research indicates that both self-management with pharmacist support and home monitoring significantly improve blood pressure control. Monitoring blood pressure at home is linked to better control and can predict heart health, helping patients manage their condition more effectively and potentially leading to important reductions in blood pressure. ^{1 2 3 6 7}

Who Is on the Research Team?

Diana Jalal, MD

Principal Investigator

Iowa City VA Health Care System, Iowa City, IA

Are You a Good Fit for This Trial?

This trial is for Veterans aged 18 or older with moderate chronic kidney disease (CKD) and uncontrolled high blood pressure. They must not be pregnant, have severe hypertension, liver disease, heart failure, cognitive decline due to dementia, or a life expectancy less than one year.

Inclusion Criteria

Your blood pressure is consistently higher than 140/90.

My kidney function is reduced, and I may have protein in my urine.

Exclusion Criteria

You are expected to live less than 1 year.

Pregnant, breastfeeding, or unwilling to use adequate birth control

Your blood pressure drops significantly when you stand up after sitting or lying down for a few minutes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either pharmacist-guided self-management or self-monitoring with standard care for blood pressure management

12 months

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Self-management of BP medications
• Self-monitoring of home BP

Trial Overview

The study compares two methods: patients managing their own blood pressure medication under a pharmacist's guidance versus standard care with home monitoring of blood pressure. It aims to see which method better lowers blood pressure in CKD patients.

How Is the Trial Designed?

Group I: Self-management Experimental Treatment 1 Intervention

Patients monitor their home BP and self manage their BP medications based on a predesigned titration protocol and under the guidance of the clinical pharmacist.

Group II: Self-monitoring Active Control 1 Intervention

Patients monitor their home BP and contact their provider if the BP is above the goal.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Home blood pressure monitoring can significantly aid in managing hypertension for patients with end-stage renal disease on hemodialysis, addressing the challenges of unreliable measurements at dialysis centers.

The study, supported by a grant from the American Nephrology Nurses' Association, utilized 35 home BP monitors, demonstrating their effectiveness in providing additional information for better blood pressure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension management in patients receiving hemodialysis: the benefits of home blood pressure monitoring. Lingerfelt, K., Hodnicki, D.[2012]

In a study of 200 chronic kidney disease (CKD) patients, self-measured office blood pressure (SMOBP) and nurse-measured office blood pressure (NMOBP) showed no significant differences in average systolic and diastolic values, indicating that both methods are similarly effective for BP monitoring.

However, in about 25% of patients, there were notable discrepancies of 10 mmHg or more between SMOBP and NMOBP, particularly in patients over 60 years, suggesting that individual measurement circumstances can lead to significant variations in BP readings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of self- and nurse-measured office blood pressure in patients with chronic kidney disease. Tougaard, BG., Laursen, KS., Jensen, JD., et al.[2021]

A new Home Blood Pressure Monitoring Adherence Scale was developed and tested on 436 patients with chronic kidney disease, demonstrating strong reliability with a Cronbach's α of 0.906 and good validity for assessing adherence to home blood pressure monitoring.

The scale consists of eight items and effectively measures adherence, making it a valuable tool for clinicians to improve blood pressure control in patients with chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development, Reliability, and Validity of the Home Blood Pressure Monitoring Adherence Scale for Patients with Chronic Kidney Disease. Wang, Y., Li, K., Li, H., et al.[2022]

In a 12-month trial involving 120 older adults (average age 79.5 years), combining home blood pressure telemonitoring with pharmacist-led case management did not significantly improve the achievement of target ambulatory blood pressure levels compared to usual care.

However, the intervention did lead to significant reductions in home blood pressure readings, although it also resulted in a higher incidence of hypotension (systolic BP < 110) without causing major adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemonitoring and protocolized case management for hypertensive community dwelling older adults (TECHNOMED): a randomized controlled trial. Lau, D., Ringrose, J., McAlister, FA., et al.[2022]

A nurse-managed, home-based hypertension management system significantly improved blood pressure control compared to standard care, with systolic BP reductions of 14.2 mm Hg in the intervention group versus 5.7 mm Hg in the control group after 6 months.

The intervention group also showed higher medication adherence (80.5% vs. 69.2%) and more frequent adjustments in drug therapy, indicating that structured support can enhance treatment effectiveness without causing adverse drug reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse management for hypertension. A systems approach. Rudd, P., Miller, NH., Kaufman, J., et al.[2022]

In a study involving 552 high-risk patients with hypertension, self-monitoring and self-titration of antihypertensive medication led to a significant reduction in systolic blood pressure by an average of 9.2 mm Hg compared to usual care after 12 months.

The self-management approach was effective across all patient subgroups and did not result in excessive adverse events, indicating it is a safe and beneficial strategy for managing blood pressure in patients with cardiovascular disease, diabetes, or chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of self-monitoring and medication self-titration on systolic blood pressure in hypertensive patients at high risk of cardiovascular disease: the TASMIN-SR randomized clinical trial. McManus, RJ., Mant, J., Haque, MS., et al.[2023]

A study involving 46 patients and 43 staff from kidney care clinics in British Columbia revealed significant gaps in knowledge and practices regarding home blood pressure monitoring (HBPM), highlighting the need for better education and implementation of best practices.

Patients and providers had differing perceptions of barriers to HBPM, with patients more likely to cite costs as a concern, while providers viewed anxiety as a barrier, indicating that tailored interventions could enhance HBPM adoption and improve blood pressure management in chronic kidney disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Patient-Provider Gap: A Cross-sectional Survey to Understand Barriers and Motivating Factors for Home Blood Pressure Monitoring in a CKD Cohort. Borkum, M., Levin, A., Williams, J., et al.[2023]

Self-measured and ambulatory blood pressure (BP) monitoring provide a more accurate assessment of hypertension in chronic kidney disease (CKD) patients compared to clinic-obtained BP, which is crucial for effective management.

Out-of-office BP monitoring is recommended for all stages of CKD, as it better predicts target-organ damage and prognosis, and is particularly effective in diagnosing hypertension in hemodialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Out-of-office blood pressure monitoring in chronic kidney disease. Agarwal, R., Peixoto, AJ., Santos, SF., et al.[2022]

Technology-based interventions, such as telemonitoring and education, can significantly enhance self-management of hypertension, as shown in a systematic review of 12 randomized controlled trials.

Combining interventions for both patients and physicians leads to better blood pressure control, suggesting that a collaborative approach is more effective in managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management of hypertension using technology enabled interventions in primary care settings. Chandak, A., Joshi, A.[2022]

In a study of 34 hemodialysis patients over 12 weeks, home blood pressure monitoring (HBPM) significantly reduced systolic blood pressure (SBP) compared to usual care, indicating its effectiveness in managing hypertension in this population.

No significant differences were observed in diastolic blood pressure (DBP) or fluid gains between the groups, suggesting that while HBPM helps with SBP control, it may not impact other related factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving blood pressure control in hypertensive hemodialysis patients. Kauric-Klein, Z., Artinian, N.[2008]

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