Blood Pressure in Dialysis Patients (NCT01421771) | Clinical Trial Compass
CompletedNot Applicable
Blood Pressure in Dialysis Patients
United States126 participantsStarted 2011-10
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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;
What they're measuring
1
Number of Participants Assessed for Intensive (110-140 mm Hg) and Standard (155-165mm Hg) Pre-dialysis Standardized BP Goal