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 BP. We recently reported that among HD patients, those with routine pre-dialysis BP values that met the 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 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. We propose to conduct a pilot RCT in a prevalent cohort of HD patients treated in facilities operated by Dialysis Clinics Inc. (DCI). To accomplish this goal we assembled an outstanding team including investigators affiliated with academic medical centers including the University of New Mexico, (Zager, Bedrick, Servilla), Tufts (Miskulin, Levey), and Medical University of South Carolina (Ploth, Budisavljevic). Dr. London (H"pital Lariboisi?re) will provide expertise in assessing aortic stiffness. Brigham and Women's Hospital (Kwong) will serve as the MRI reading center. The Cleveland Clinic Foundation (Gassman) will serve as the Data Coordinating Center. Drs. Zager, Miskulin and Ploth will be the Principal Investigators.

Public Health Relevance

(1) It is feasible to conduct a RCT in which HD patients are randomized to a standardized pre-dialysis systolic blood pressure (SBP) of <140 mmHg or <160 mmHg. (2) There we will be a significant difference in the changes in left ventricular mass index (LVMI), assessed by magnetic resonance imaging between the two BP arms.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK083424-03
Application #
8303440
Study Section
Special Emphasis Panel (ZDK1-GRB-D (O1))
Program Officer
Kusek, John W
Project Start
2010-07-15
Project End
2014-06-30
Budget Start
2012-07-01
Budget End
2014-06-30
Support Year
3
Fiscal Year
2012
Total Cost
$502,331
Indirect Cost
$39,239
Name
University of New Mexico
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
868853094
City
Albuquerque
State
NM
Country
United States
Zip Code
87131
Gul, Ambreen; Miskulin, Dana; Gassman, Jennifer et al. (2014) Design of the Blood Pressure Goals in Dialysis pilot study. Am J Med Sci 347:125-30
Shafi, Tariq; Waheed, Sana; Zager, Philip G (2014) Hypertension in hemodialysis patients: an opinion-based update. Semin Dial 27:146-53