Blood Pressure Management for Chronic Kidney Failure

(Home-BP Trial)

Not currently recruiting at 1 trial location

Overseen By Ernest Ayers, MSPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must be taking: Antihypertensives

Disqualifiers: Pregnancy, Incarceration, Other study, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks the best method to manage blood pressure in individuals with chronic kidney failure undergoing regular dialysis. It compares two approaches: targeting blood pressure before dialysis and focusing on blood pressure at home. Participants will have their anti-hypertensive medications and dry weight adjusted to meet blood pressure goals. Individuals on dialysis for over three months with high blood pressure (over 140 mmHg or taking blood pressure medications) may qualify. As an unphased trial, this study provides participants the chance to contribute to significant research that could enhance blood pressure management for dialysis patients.

Will I have to stop taking my current medications?

The trial involves adjusting anti-hypertensive medications (medications for high blood pressure) to achieve a target blood pressure, so your current medications may be changed. The protocol does not specify if you must stop taking them entirely.

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

Research has shown that medications for high blood pressure are generally safe for people with chronic kidney disease. These medications are important because they slow kidney damage and lower the risk of heart problems. Studies suggest starting with drugs like ACE inhibitors or ARBs, which are usually well-tolerated and help reduce protein in the urine, benefiting kidney health.

For dialysis patients, adjusting "dry weight"—the ideal weight without extra fluid—safely and effectively manages blood pressure. This simple and well-tolerated method helps those on hemodialysis control their blood pressure.

Both approaches have been used in people with kidney disease and high blood pressure, and research supports their safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for chronic kidney failure, which typically involve managing blood pressure primarily in clinical settings, this trial explores a more personalized approach by focusing on home monitoring. Researchers are excited about this trial because it investigates whether more frequent home-based blood pressure readings can improve management of hypertension in kidney failure patients. The trial aims to understand if adjusting medications based on home readings, rather than solely relying on pre-dialysis measurements, can lead to better blood pressure control and potentially improve patient outcomes. This approach could empower patients to take a more active role in their health management, offering a tailored method that adapts to their daily life.

What evidence suggests that this trial's treatments could be effective for managing blood pressure in chronic kidney failure?

Research has shown that managing blood pressure is crucial for individuals with chronic kidney failure. In this trial, participants will join different treatment arms to evaluate the effectiveness of various blood pressure targets. One arm will focus on maintaining a home systolic blood pressure below 140 mmHg, while another will aim for a pre-dialysis systolic blood pressure below 140 mmHg. Additionally, an exploratory arm will target a home systolic blood pressure below 130 mmHg. Blood pressure medications can slow kidney disease progression and reduce heart problems. Adjusting dry weight, the ideal weight without extra fluid, also helps control blood pressure and reduces hospital visits. Overall, these methods have been successful in managing high blood pressure in kidney patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Nisha Bansal, MD

Principal Investigator

University of Washington

Chi-yuan Hsu, MD, MSc

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic kidney failure or disease, on in-center hemodialysis for at least 3 months, and have high blood pressure. They must be able to measure their BP at home and dialysis, not expecting a kidney transplant or change in treatment within 10 months, and not part of another study that affects BP.

Inclusion Criteria

You are expected to live for at least 10 more months.

I have high blood pressure or am on medication for it.

I am receiving hemodialysis three times a week for kidney failure.

Exclusion Criteria

You are in jail or a similar institution where it's not possible to measure your blood pressure at home.

I am not pregnant, planning to become pregnant, or breastfeeding.

Participating in another intervention study that may affect blood pressure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-month cross-over randomized controlled trial targeting home vs. pre-dialysis systolic blood pressure <140 mmHg

10 months

Blood pressure reviewed every two weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Extension

An optional 2-month study targeting home systolic blood pressure <130 mmHg

2 months

Home blood pressures reviewed every two weeks

What Are the Treatments Tested in This Trial?

Interventions

• Anti-hypertensive medications
• Dry weight target adjustment

Trial Overview The study compares two methods to manage blood pressure in patients undergoing hemodialysis: one targets home-measured systolic BP <140 mmHg while the other focuses on pre-dialysis measurements. Both use dry weight adjustments and anti-hypertensive meds following an algorithm.

How Is the Trial Designed?

Group I: Home Systolic Blood Pressure <140 mmHg Experimental Treatment 2 Interventions

Participants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of \<140 mmHg.

Group II: Home Systolic Blood Pressure <130 mmHg Experimental Treatment 2 Interventions

This will be an optional, exploratory 2 month study at the end of the primary 10-month trial. Participants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of \<130 mmHg.

Group III: Pre-Dialysis Systolic Blood Pressure <140 mmHg Active Control 2 Interventions

Participants will have their blood pressure taken by an automated blood pressure device by dialysis unit staff using regular dialysis unit equipment according to usual clinical care. Pre-dialysis blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a pre-dialysis systolic blood pressure target of \<140 mmHg.

Anti-hypertensive medications is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Antihypertensive medications for:

• Hypertension
• Heart failure
• Kidney disease

Approved in United States as Antihypertensive medications for:

• Hypertension
• Heart failure
• Kidney disease
• Stroke prevention

Approved in Canada as Antihypertensive medications for:

• Hypertension
• Heart failure
• Kidney disease

Approved in Japan as Antihypertensive medications for:

• Hypertension
• Heart failure

Approved in China as Antihypertensive medications for:

• Hypertension
• Heart failure
• Kidney disease

Approved in Switzerland as Antihypertensive medications for:

• Hypertension
• Heart failure

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Hypertension is frequently linked to renal failure, and understanding the mechanisms behind this relationship is crucial for effective treatment.

Combination antihypertensive therapy is often required for managing high blood pressure in patients with renal failure, and specific antihypertensive agents are discussed to optimize kidney function outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension in renal failure. Townsend, RR., Cirigliano, M.[2019]

Effective control of hypertension is crucial for slowing the progression of renal disease, as hypertension is closely linked to both acute and chronic renal conditions.

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers not only lower blood pressure but also provide protective effects on kidney function, particularly in patients with diabetic nephropathy, suggesting they may help prevent further decline in renal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of angiotensin-converting enzyme inhibitors and angiotensin-receptor blockers in the prevention of progression of renal disease. Ram, CV., Vergne-Marini, P.[2019]

SGLT2 inhibitors have been shown to provide modest blood pressure-lowering effects in patients with chronic kidney disease, heart failure, obesity, and diabetes, making them a potential adjunctive therapy for those who struggle to reach blood pressure targets.

The mechanisms behind the antihypertensive effects of SGLT2 inhibitors include increased sodium excretion (natriuresis), changes in blood flow dynamics, and effects similar to diuretics, which may be particularly beneficial for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anti-hypertensive effects of sodium-glucose cotransporter-2 inhibitors. Kugathasan, L., Dubrofsky, L., Advani, A., et al.[2023]

Hypertension is a significant risk factor for cardiovascular complications in patients with chronic renal disease, making careful blood pressure monitoring essential.

Starting antihypertensive treatment early, especially with alternative medications like beta-blockers or calcium antagonists, can help manage blood pressure and potentially slow the progression of chronic renal failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of arterial hypertension in non-oliguric renal failure]. Beretta-Piccoli, C.[2006]

Effective management of hypertension in patients with chronic kidney disease is crucial for reducing cardiovascular risks and slowing kidney failure progression, emphasizing the importance of nephroprotection.

Combination therapy using renin-angiotensin-aldosterone system inhibitors and diuretics is often necessary, with specific blood pressure targets set based on proteinuria levels, highlighting the need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of hypertension in chronic kidney disease]. Jędras, M., Sawicka, M.[2015]

Chronic kidney disease (CKD) and high blood pressure often occur together, with many patients experiencing resistant hypertension that complicates treatment, especially in advanced stages of CKD.

Effective management of high blood pressure is crucial in CKD patients as it not only reduces the risk of serious cardiovascular events like heart attacks and strokes but also helps slow the progression of kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of high blood pressure in patients with chronic kidney disease : Summary of recent guidelines]. Hougardy, JM., Leeman, M.[2018]

In a study of 3,089 hypertensive patients with chronic renal insufficiency (CRI), blood pressure control was found to be suboptimal, with only 68% achieving systolic BP < 160 mm Hg and diastolic BP < 90 mm Hg, regardless of their level of kidney function.

Patients with lower creatinine clearance (CrCl 21 to 40 mL/min) were significantly less likely to be prescribed ACE inhibitors compared to those with better kidney function (CrCl >60 mL/min), indicating a need for improved management strategies in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood pressure and angiotensin converting enzyme inhibitor use in hypertensive patients with chronic renal insufficiency. Hsu, CY., Bates, DW., Kuperman, GJ., et al.[2019]

Aggressive treatment of hypertension is crucial for preventing cardiovascular disease, with recommendations to lower blood pressure to below 140 mm Hg systolic and 90 mm Hg diastolic, especially in high-risk patients.

Lifestyle modifications should be part of the treatment plan for all hypertensive patients, and while thiazide diuretics and beta-blockers are well-supported by clinical trial data, achieving overall blood pressure control remains a significant challenge, with only 25% of patients reaching target levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of cardiovascular disease in hypertensive patients with normal renal function. Wright, JT., Douglas, JG., Rahman, M.[2019]

Hypertensive patients with chronic renal failure have a worse prognosis compared to normotensive patients, highlighting the importance of effective antihypertensive treatment.

Antihypertensive therapies, particularly ACE inhibitors and calcium antagonists, have been shown to improve the progression of chronic renal failure by targeting key factors involved in hypertension and organ damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of antihypertensive therapy on the course of renal failure. Lederle, RM.[2005]

Patients with chronic renal failure often experience multiple cardiovascular risk factors, including hypertension, which is the most treatable; however, careful selection of antihypertensive medications is crucial to avoid worsening other risk factors.

Proper management of hypertension in patients with chronic renal failure can help preserve remaining kidney function and potentially delay the need for dialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of various antihypertensive agents on cardiovascular risk factors in patients with renal failure. Zarama, M., Raij, L.[2019]

Managing hypertension in patients with kidney disease often requires a combination of at least three antihypertensive medications, including an ACE inhibitor and a diuretic, to meet recommended blood pressure goals of <130/85 mmHg.

Despite treatment efforts, only 11% of patients with diabetic kidney disease achieve these blood pressure targets, highlighting the need for improved physician education and patient awareness to prevent the progression of kidney disease and the need for dialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of hypertension in patients with renal disease. Garg, J., Bakris, GL.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6422950/

Management of Hypertension in Chronic Kidney Disease Control of hypertension is important in those with CKD as it leads to slowing of disease progression as well as reduced CVD risk.

2. academic.oup.com academic.oup.com/ndt/article/38/12/2694/7207411

Hypertension in chronic kidney disease—treatment standard ... In this article, we review the current standards of treatment and discuss novel developments in pathophysiology, diagnosis, outcome prediction and management ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6404880/

Use of Antihypertensive Agents and Association With Risk of ... During median follow‐up of 7.5 years, renin‐angiotensin‐aldosterone system inhibitor use plateaued during CKD stage 3 (75%) and declined to 37% by stage 5, ...

4. nature.com nature.com/articles/hr2012157

The effect of antihypertensive drugs on chronic kidney ... The present article will review the latest data on the role and properties of each class of antihypertensive drugs on CKD.

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/486513

Renal Outcomes in High-Risk Hypertensive Patients ... Renal outcomes in high-risk hypertensive patients treated with an angiotensin-converting enzyme inhibitor or a calcium channel blocker vs a diuretic.

6. ahajournals.org ahajournals.org/doi/10.1161/HYP.0000000000000249

2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ ... High blood pressure is the most prevalent and modifiable risk factor for the development of cardiovascular diseases, including coronary artery ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2827625

Chlorthalidone vs Hydrochlorothiazide and Kidney ... Thiazide diuretics have been demonstrated to reduce blood pressure and the incidence of cardiovascular outcomes in those with hypertension. They ...

8. kidney-international.org kidney-international.org/article/S0085-2538(20)31270-9/fulltext

KDIGO 2021 Clinical Practice Guideline for the ... Practice Point 5.3: Use ACEi or ARB as first-line therapy for high BP in children with CKD. These drugs lower proteinuria and are usually well tolerated, but ...