Blood Pressure Management for Chronic Kidney Failure

(Home-BP Trial)

Recruiting at 1 trial location

Overseen By Jennifer Tsing

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

200 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug for managing blood pressure in chronic kidney failure?

Research shows that antihypertensive drugs, like ACE inhibitors and calcium antagonists, can help slow the progression of chronic kidney failure by effectively managing high blood pressure. These drugs not only control blood pressure but also have protective effects on the kidneys, which is crucial for patients with chronic kidney disease. ^{1 2 3 4 5}

Is it safe to use blood pressure medications for managing chronic kidney failure?

Blood pressure medications, also known as antihypertensives, are generally considered safe for managing chronic kidney failure. They help control high blood pressure, which is a common issue in kidney disease, and can potentially slow the progression of kidney failure. However, it's important to choose the right medication to avoid worsening other health issues. ^{2 6 7 8 9}

How is the drug for blood pressure management in chronic kidney failure different from other treatments?

This drug is unique because it often requires a combination of different types of blood pressure medications, such as beta-blockers, calcium antagonists, and converting enzyme inhibitors, tailored to the patient's specific kidney condition and other health factors. This approach not only helps manage blood pressure but also slows the progression of kidney disease and reduces the risk of heart-related complications. ^{2 3 7 10 11}

What is the purpose of this trial?

The main study will be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with end-stage-kidney-disease treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure \<140 mmHg to reduce rates of intradialytic hypotension. The target systolic blood pressure of \<140 mmHg in both treatment groups will be achieved using an algorithm of dry weight adjustment and anti-hypertensive medication adjustment.

Research Team

Nisha Bansal, MD

Principal Investigator

University of Washington

Chi-yuan Hsu, MD, MSc

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

[Treatment of arterial hypertension in non-oliguric renal failure]. [2006]

3. Belgium pubmed.ncbi.nlm.nih.gov

[Management of high blood pressure in patients with chronic kidney disease : Summary of recent guidelines]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Role of angiotensin-converting enzyme inhibitors and angiotensin-receptor blockers in the prevention of progression of renal disease. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Blood pressure and angiotensin converting enzyme inhibitor use in hypertensive patients with chronic renal insufficiency. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The effects of various antihypertensive agents on cardiovascular risk factors in patients with renal failure. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Hypertension in renal failure. [2019]

8. England pubmed.ncbi.nlm.nih.gov

The anti-hypertensive effects of sodium-glucose cotransporter-2 inhibitors. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Prevention of cardiovascular disease in hypertensive patients with normal renal function. [2019]

10. Poland pubmed.ncbi.nlm.nih.gov

[Treatment of hypertension in chronic kidney disease]. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Treatment of hypertension in patients with renal disease. [2019]