Blood Pressure Management for Chronic Kidney Failure
(Home-BP Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Washington
Must be taking: Antihypertensives
Disqualifiers: Pregnancy, Incarceration, Other study, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
26789How 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.
2371011Eligibility 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.
+5 more
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
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Home Systolic Blood Pressure <140 mmHgExperimental Treatment2 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 mmHgExperimental Treatment2 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 mmHgActive Control2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of WashingtonSeattle, WA
University of California San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
University of WashingtonLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
University of California, San FranciscoCollaborator
References
The effect of antihypertensive therapy on the course of renal failure. [2005]The course and prognosis of chronic renal failure are much worse in hypertensive patients than in normotensive patients with otherwise similar basic disease. Therefore, antihypertensive measures with a combination of diuretics, beta-blockers, and vasodilators have clearly been shown to improve the progression of diabetic nephropathy. Treatment of hypertension with angiotensin-converting enzyme (ACE) inhibitors has also been shown to have a favorable effect on the prognosis of chronic renal failure. In the past few years, more knowledge about the pathogenesis of hypertension and the development of hypertension-induced organ damage has been followed by changing attitudes to antihypertensive therapy and the introduction of calcium antagonists for the treatment of hypertension, even in chronic renal failure. ACE inhibitors and calcium antagonists seem to be advantageous in the prognosis of chronic renal failure as they act on the humoral and trophogenic factors now known to be important in antihypertensive therapy.
[Treatment of arterial hypertension in non-oliguric renal failure]. [2006]In patients with chronic renal disease, hypertension represents an important risk factor for the development of cardiovascular complications. Moreover, it appears possible that the progression of chronic renal failure may be slowed by carefully adjusted antihypertensive therapy. Therefore, blood pressure needs to be monitored very closely in patients with kidney disease and, when indicated, antihypertensive treatment should be started as soon as blood pressure begins to rise. Antihypertensive treatment of patients with non-oliguric renal failure has usually been started with dietary salt restriction and diuretic monotherapy. Other drugs, such as beta-blockers, sympathicolytic and/or vasodilating agents have been added successively. The possibility of beginning antihypertensive therapy with alternative compounds (beta-blocker, calcium antagonists and converting enzyme inhibitors) in patients with non-oliguric renal failure is discussed.
[Management of high blood pressure in patients with chronic kidney disease : Summary of recent guidelines]. [2018]Chronic kidney disease and high blood pressure are two common diseases that mutually maintain during their evolution. In the advanced stages of chronic kidney disease, most pat ients are hypertensive and show signs of vascular disease (coronary artery disease, cerebrovascular or peripheral). Almost one third of the patients with advanced chronic kidney disease exhibit resistant hypertension that requires complex therapeutic management. In chronic kidney disease, antihypertensive treatment is conditioned by comorbidities, but also by proteinuria, which is an independent cardiovascular risk factor in addition to the rate of glomerular filtration rate. The treatment of high blood pressure is a cornerstone of the management of the chronic kidney disease. It limits the risk of cardiovascular events (eg. myocardial infarction, stroke), but also slows the progression of chronic kidney disease. Various recommendations have been recently published on the subject in order to offer assistance to the therapeutic management of hypertension in the patient suffering from chronic kidney disease. The purpose of this article is to highlight these main key elements.
Role of angiotensin-converting enzyme inhibitors and angiotensin-receptor blockers in the prevention of progression of renal disease. [2019]Systemic hypertension is common in patients with acute as well as with chronic renal diseases. Hypertension is an important factor that contributes to the progression of renal failure. Cardiovascular disease is the leading cause of death and disability in patients with chronic renal failure and in those receiving renal replacement therapy. The prevalence of hypertensive nephropathy remains unabated. Hypertension and chronic renal failure are closely interlinked and govern the morbidity and mortality in patients afflicted by these conditions. There is considerable hope that effective control of hypertension may retard the progression of renal disease. Although mere control of hypertension is of paramount importance, specific pharmacologic approaches may offer certain important renal advantages. Angiotensin-converting enzyme (ACE) inhibitors, by the virtue of their intrarenal effects, exert favorable consequences on the kidney function (and structure, to some extent), particularly in patients with diabetic nephropathy and hypertension. Both experimental and clinical studies have demonstrated the renoprotective effects of ACE inhibitors; these drugs slow down the progression of renal disease independent of their antihypertensive actions. More recently, angiotensin-receptor blockers have been shown to exert similar glomerular effects as ACE inhibitors. Preliminary clinical data also suggest a possible role for angiotensin-receptor blockers in the prevention of progression of renal failure. Therapeutic agents that inhibit the renin-angiotensin axis hold considerable promise in the management of patients with renal disease by slowing down the rate of decline in renal function.
Blood pressure and angiotensin converting enzyme inhibitor use in hypertensive patients with chronic renal insufficiency. [2019]Hypertension treatment is important in managing chronic renal insufficiency (CRI). Little is known, however, about the blood pressure (BP) control achieved or the pattern of antihypertensive drug prescription among CRI patients.
The effects of various antihypertensive agents on cardiovascular risk factors in patients with renal failure. [2019]Systemic cardiovascular diseases are the most important cause of morbidity and mortality among patients with chronic renal failure. Hypertension, lipid-profile abnormalities, glucose intolerance, and left ventricular hypertrophy are found in most patients with chronic renal failure and are responsible for the increased incidence of atherosclerosis. Hypertension is the risk factor most susceptible to treatment, but consideration must be given in selecting an antihypertensive agent not only to its effect on blood pressure but to its effects on the other risk factors. Improper selection could impair the long-term benefit of good blood pressure control by increasing the severity of the other cardiovascular risk factors and eventually worsening the prognosis of the chronic renal failure. The remaining renal function in patients not yet in end-stage renal failure deserves special consideration; an adequate antihypertensive regimen could potentially delay the need for dialysis.
Hypertension in renal failure. [2019]Hypertension is a common component of the morbidity associated with renal failure. The mechanisms that contribute to high blood pressure are reviewed in this section. Also covered are therapies to reduce hypertension, the treatment goals of those therapies, and the outcomes of antihypertensive therapy on kidney function in patients with renal failure. Various antihypertensive agents are specifically addressed, and a treatment paradigm is presented for combination antihypertensive drug therapy, which is usually necessary in the antihypertensive therapy of patients with renal failure.
The anti-hypertensive effects of sodium-glucose cotransporter-2 inhibitors. [2023]Hypertension is a well-established risk factor for cardiovascular (CV) events in patients with chronic kidney disease (CKD), heart failure, obesity, and diabetes. Despite the usual prescribed antihypertensive therapies, many patients fail to achieve the recommended blood pressure (BP) targets.
Prevention of cardiovascular disease in hypertensive patients with normal renal function. [2019]Hypertension is an important risk factor for cardiovascular disease (CVD) in patients with normal renal function. After reviewing over two decades of clinical trial data and an even longer history of epidemiologic data, multiple consensus panels worldwide have made recommendations for the aggressive treatment of hypertension using both lifestyle modification and drug therapy. These data and recommendations provide the basis of the recommendations for preventing CVD in patients with renal disease. Most patients should have elevated blood pressure (BP) lowered to less than 140 mm Hg systolic and less than 90 mm Hg diastolic. Earlier and more aggressive intervention is recommended in high-risk hypertensive patients with risk factors (especially diabetes mellitus) or evidence of target organ damage or clinical CVD. Lifestyle changes are indicated as either initial therapy or concomitant therapy in all hypertensive patients to lower BP and to normalize other CVD risk factors. There is general agreement that clinical outcome data from controlled clinical trials should guide the selection of antihypertensive agents. Currently, these data are only available for thiazide diuretics and beta-blockers for most hypertensive patients with normal renal function and for the dihydropyridine calcium channel blockers in older hypertensive patients with isolated systolic hypertension. However, data may support the use of other agents in hypertensives with selected comorbidity (eg, ACE inhibitors in heart failure, beta-blockers after myocardial infarction, and so forth). However, with only 25% of hypertensive patients controlled to less than 140/90 mm Hg, achieving blood pressure control remains the most important goal in managing hypertension in this population.
[Treatment of hypertension in chronic kidney disease]. [2015]Adequate treatment of hypertension in patients with chronic kidney disease reduces the risk of cardiovascular complications, slows down the progression of renal failure, and is an important element in nephroprotection, delaying the onset of renal replacement therapy. Non-pharmacological methods, especially salt restriction, and most of the available antihypertensive medicines are in use. It is often necessary to combine drugs from different groups, among which inhibitors of renin-angiotensin-aldosterone (RAA) system and diuretics are the most important. The choice of an appropriate combination depends on the degree of renal failure, concomitant diseases, extent of proteinuria, and the presence or absence of edema and hypervolemia. Recommended blood pressure is below 140/90 mmHg in patients with proteinuria less than 0.5 g/24 h, and below 130/80 mmHg if daily proteinuria exceeds 0.5 g/24 h.
Treatment of hypertension in patients with renal disease. [2019]Management of hypertension in people with kidney disease is challenging and generally requires at least three different and complementary acting antihypertensive agents to achieve the recommended blood pressure goal by the JNC VI and WHO guidelines of