Blood Pressure in Dialysis Patients

Completed · Not applicable

Conditions studied: Hypertension, Renal Failure Chronic Requiring Hemodialysis, Blood Pressure, Dialysis

In brief

Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although studies in the general population have demonstrated a continuous reduction in CV risk with each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in hemodialysis (HD) patients have demonstrated that patients with mild to moderate hypertension may have decreased mortality compared to those with normal blood pressure (BP). The investigators recently reported that among HD patients, those with routine pre-dialysis BP values that met the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines (\<140/90 mm Hg) had increased mortality compared to patients with mild to moderate hypertension. However, these observational studies included untreated patients in whom low or normal BP may reflect significant cardiac disease or other comorbid conditions. In the setting of reduced vascular compliance and impaired autoregulation, aggressive BP lowering may decrease coronary or cerebral perfusion. Thus, it is unclear if aggressive BP lowering will be harmful or beneficial. A well-designed randomized control trial (RCT) is needed to answer this important question. Prior to conducting a full-scale RCT it is prudent to conduct a pilot study to assess feasibility and inform the design of the former. The investigators propose to conduct a pilot RCT in a prevalent cohort of HD patients to assess the safety and feasibility of treating patients to a low (110-140 mmHg)and standard (155-165) mm Hg pre-dialysis BP target.

Key facts

Study ID

NCT01421771

Run by

University of New Mexico

People needed

126

Starts

2011-10-01

Expected to finish

2016-06-01

Last updated by the study team

2023-11-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• On thrice weekly maintenance hemodialysis for greater than 90 days
• For entry into baseline period: 2-week average RDUSBPM > 155 mm Hg on AHT medications or < 155 mm Hg on ≥ 1 AHT medications For randomization: 2-week average SDUSBPM ≥ 155 mm Hg

You may not qualify if…

• Two- week average, pre-dialysis mid-week SDUSBPM ≥180 mmHg on maximal doses of ≥ 4 antihypertensive agents;
• Inability to measure blood pressures in an upper arm;
• History of inter or post-dialytic hypotension (defined as systolic blood pressure <90 mmHg) within the past 2 weeks or inter- or post- dialytic hypotension requiring hospitalization (including emergency room visit) and/or the use of midodrine in the past 6 months;
• Required one or more urgent, unscheduled dialysis treatment for congestive heart failure in the past 3 months (other than in an incident patient at the time of starting dialysis);
• Acute myocardial infarction, unstable angina or stroke/ TIA in past three the 3 months;
• Severe aortic valve stenosis (valve area <1cm 2) carotid artery stenosis (>70% stenosis);
• Known abdominal aortic aneurysm >5 cm in diameter or thoracic aortic aneurysm of any diameter;
• Body mass index >40 kg/m2 or arm circumference > 52 cm, which precludes measuring blood pressure with the "thigh" blood pressure cuff;
• Life expectancy <1 year;
• A living donor, kidney transplant, or switch to peritoneal dialysis scheduled within the next year;
• Significant cognitive impairment;
• spKt/V ≤1.2 in the past 2 months;
• Active liver disease;
• Active alcohol or substance abuse including narcotics within the past year;
• Contraindication to cardiac MRI;
• Current or planned pregnancy within the next year;
• Unwillingness to consent to pregnancy test and/or use of birth control if of childbearing potential;
• Suspicion that the participant will not be willing or able to adhere to prescribed medications and study protocol;
• Incarcerated;
• Significant concern about the study expressed by spouse, significant other, family member primary nephrologist or primary care physician;
• Participation in another intervention study;
• Unable to speak or understand English or Spanish;
• Plan to relocate within one year;
• participation in another intervention study .

Where it is running

• Dialysis Clinic Inc - Boston — Boston, Massachusetts, United States
• DaVita Boston — Boston, Massachusetts, United States
• Dialysis Clinic Inc - Walden Pond Clinic — Concord, Massachusetts, United States
• Dialysis Clinic Inc - Faulkner — Jamaica Plain, Massachusetts, United States
• Dialysis Clinic Inc - Somerville — Somerville, Massachusetts, United States
• Dialysis Clinic Inc - Albuquerque — Albuquerque, New Mexico, United States
• Dialysis Clinic Inc - Albuquerque South — Albuquerque, New Mexico, United States
• Dialysis Clinic Inc - Albuquerque East — Albuquerque, New Mexico, United States
• Dialysis Clinic Inc - Grants — Grants, New Mexico, United States
• Dialysis Clinic Inc - Rio Rancho — Rio Rancho, New Mexico, United States
• Centers for Dialysis Care East — Cleveland, Ohio, United States
• Centers for Dialysis Care - Shaker Heights — Cleveland, Ohio, United States
• Dialysis Clinic Inc - Oakland — Pittsburgh, Pennsylvania, United States
• Dialysis Clinic Inc - Banksville — Pittsburgh, Pennsylvania, United States
• Dialysis Clinic Inc - Point Breeze — Pittsburgh, Pennsylvania, United States
• Dialysis Clinic Inc - North Hills — Pittsburgh, Pennsylvania, United States
• Dialysis Clinic Inc - Magnolia Court — Charleston, South Carolina, United States
• Dialysis Clinic Inc - West Ashley — Charleston, South Carolina, United States
• Dialysis Clinic Inc - James Island — Charleston, South Carolina, United States
• Dialysis Clinic Inc - East Cooper — Mt. Pleasant, South Carolina, United States
• Dialysis Clinic Inc - Azalea Place — North Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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