Blood Pressure in Dialysis Patients

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.

Conditions

• Hypertension
• Renal Failure Chronic Requiring Hemodialysis
• Blood Pressure
• Dialysis

Interventions

DRUG

Antihypertensive Agents

Study formulary consists of ACE/ARB, Beta Adrenergic Blocker, Calcium Channel Blocker, vasodilators, peripheral alpha antagonist and central alpha agonist. ACE I or ARB is first line, the order of addition of subsequent medications is per the discretion of the investigator

OTHER

Dry weight Challenge

Reduce the estimated dry weight of the patient's progressively over 2 -week intervals until the dry weight challenge is no longer tolerated or the patient is at BP goal

DIETARY_SUPPLEMENT

Extend dialysis treatment time and re-challenge estimated dry weight

Extend dialysis treatment time and re-challenge estimated dry weight

Sponsors & Collaborators

• Tufts Medical Center

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• University of Pittsburgh Medical Center

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Case Western Reserve University

  collaborator OTHER

• University of New Mexico

  lead OTHER

Principal Investigators

• Philip Zager, MD · University New Mexico

• Dana Miskulin, PhD · Tufts Medical Center

• Jennifer Gassman, MD · The Cleveland Clinic

• David Ploth, MD · Medical University of South Carolina

• Manisha Jhamb · University of Pittsburgh

• Mahboob Rahman · Case Western Reserve University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-10-31

Primary Completion

2016-01-31

Completion

2016-06-30

Countries

• United States

Study Locations