Status:
COMPLETED
Blood Pressure in Dialysis Patients
Lead Sponsor:
University of New Mexico
Collaborating Sponsors:
Tufts Medical Center
Medical University of South Carolina
Conditions:
Hypertension
Renal Failure Chronic Requiring Hemodialysis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 syst...
Detailed Description
Mortality and morbidity among hemodialysis (HD) patients remain unacceptably high, thus there is a compelling need to improve clinical outcomes. Accordingly, the National Kidney Foundation's Kidney Di...
Eligibility Criteria
Inclusion
- 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;
- 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 .
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01421771
Start Date
October 1 2011
End Date
June 1 2016
Last Update
November 30 2023
Active Locations (21)
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1
Dialysis Clinic Inc - Boston
Boston, Massachusetts, United States, 02111
2
DaVita Boston
Boston, Massachusetts, United States, 02118
3
Dialysis Clinic Inc - Walden Pond Clinic
Concord, Massachusetts, United States, 01742
4
Dialysis Clinic Inc - Faulkner
Jamaica Plain, Massachusetts, United States, 02130