Study of the Effect of Intradialytic Vasopressin on Chronic Hypertension in Patients With End Stage Renal Disease



Status:Terminated
Conditions:High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:October 2010
End Date:August 2018

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Pilot Study of the Effect of Intradialytic Vasopressin Infusion on Chronic Blood Pressure Control in Hypertensive Patients With End Stage Renal Disease: A Program to Develop a Decisive, Randomized Controlled Trial

The death rate of patients with endstage renal disease (ESRD) on dialysis each year is 20%,
with diseases related to the heart and blood vessels causing about half. About 60% of
patients on hemodialysis have high blood pressure, which is poorly controlled in most. Normal
blood pressure in these patients greatly improves the chance of living. Increased fluid in
the body and bloodstream is a major cause of hypertension in patients with ESRD. Fluid
removal during hemodialysis is often limited by symptoms of low blood pressure during the
procedure. Therefore the increase in fluid and related high blood pressure is ongoing for
many of these patients. Arginine vasopressin (AVP) is a hormone naturally produced by the
body which has little effect on blood pressure in healthy people, but acts as a powerful
vasoconstrictor (narrows the blood vessels) when blood pressure is threatened. Recent studies
have shown when there is too little AVP, patients are more likely to have low blood pressure
during dialysis that limits fluid removal, an effect that can be reversed by giving these
patients low doses of AVP. This phase II trial will find out which of two doses of AVP (.15
or .30 mU kg-1 min-1), in combination with standard therapy, works best to change
interdialytic 44-hour ambulatory systolic blood pressure after 2 weeks. Patients who enroll
in this study will be divided into three groups. One group will be given a 0.15 mU kg-1 min-1
dose of AVP at each dialysis session over a 2-week period; the second group will be given AVP
0.3 mU kg-1 min-1 at the same interval; and a third group will be given normal saline
(placebo) at the same interval. All patients will be closely monitored for side-effects.

This pilot study originally enrolled a group of 12 subjects (4 subjects per arm) in order to
demonstrate feasibility with the primary outcome measure, interdialytic 44-hour ambulatory
systolic blood pressure. Data on the original subjects is complete and results are posted. We
are now reopening study enrollment and increasing the total number of subjects to 36 (12
subjects per arm) in order to make some initial statistical comparisons between groups, which
will help establish greater confidence in our novel method for controlling blood pressure in
dialysis patients.

Inclusion Criteria:

- End Stage Renal Disease on Hemodialysis greater than 3 months

- Hypertension (Predialysis systolic blood pressure (SBP) greater than 140 mmHg,
averaged over preceding 6 dialysis treatments)

- Stable dry weight over preceding 6 dialysis treatments

Exclusion Criteria:

- Age less than 18 years

- Clinically significant vascular disease*

- Predialysis systolic blood pressure (SBP) greater than 200 mmHg or diastolic blood
pressure (BP) >110

- Pregnancy

- Long QTc syndrome (an electrocardiogram (ECG) will be performed if unavailable within
the last 3 months)

Clinically significant vascular disease is defined as any of the following occurring in the
preceding three months: angina, claudication, transient ischemic attack, myocardial
infarction, cerebrovascular accident, or decompensated heart failure. Furthermore, patients
will be excluded if they have any history of ischemic colitis or Raynaud's disease.
We found this trial at
1
site
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Anjali Ganda, M.D., M.S.
Phone: 212-305-3273
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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mi
from
New York, NY
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