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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Anjali Ganda, MD, Columbia University
ClinicalTrials.gov Identifier:
NCT01247090
First received: November 22, 2010
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention Phase
Hypertension
End Stage Renal Disease
Drug: Vasopressin - Very Low Dose
Drug: Vasopressin - Low Dose
Drug: Placebo Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in Mean Interdialytic 44-hour Ambulatory Systolic Blood Pressure Over a 2 Week Follow-up Period [ Time Frame: Baseline and Two Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: October 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1: Vasopressin - Very Low Dose
0.15 mU per kg per minute
Drug: Vasopressin - Very Low Dose
Intradialytic vasopressin (AVP) infusion. The dose is calculated based upon the individual's weight in kilograms. A kilogram is equal to 2.2 pounds. For example, a person who weighs 70 kg (or 154 pounds) would receive a dose equal to 0.15 mU * 70 kg, or 10.5 mU of AVP per minute by infusion at their thrice-weekly dialysis treatments.
Other Names:
  • Vasopressin Injection
  • USP (8-L arginine vasopressin)
  • AVP
  • Pitressin®
Active Comparator: Group 2: Vasopressin - Low Dose
0.30 mU per kg per minute
Drug: Vasopressin - Low Dose
Intradialytic vasopressin (AVP) infusion. The dose is calculated based upon the individual's weight in kilograms. A kilogram is equal to 2.2 pounds. For example, a person who weighs 70 kg (or 154 pounds) would receive a dose equal to 0.30 mU * 70 kg, or 21 mU of AVP per minute by infusion at their thrice-weekly dialysis treatments.
Other Names:
  • Vasopressin Injection
  • USP (8-L arginine vasopressin)
  • AVP
  • Pitressin®
Placebo Comparator: Group 3: Placebo
No Dose
Drug: Placebo Comparator
Participants in Group 3 will receive an equal volume of normal saline (placebo) infusion during their standard thrice-weekly dialysis treatments.
Other Name: Normal saline

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247090

Contacts
Contact: Anjali Ganda, M.D., M.S. 212-305-3273 ag355@cumc.columbia.edu
Contact: Melanie Foley 212-305-5038 mf2162@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Anjali Ganda, M.D., M.S.    212-305-3273    ag355@cumc.columbia.edu   
Contact: Melanie Foley    212-305-5038    mf2162@cumc.columbia.edu   
Principal Investigator: Anjali Ganda, M.D., M.S.         
Sub-Investigator: Donald Landry, M.D., Ph.D.         
Sub-Investigator: Bruce Levin, Ph.D.         
Sub-Investigator: Jai Radhakrishnan, M.D.         
Sub-Investigator: John Thompson, Ph.D.         
Sub-Investigator: Anthony Valeri, M.D.         
Sub-Investigator: Joseph Schwartz, Ph.D.         
Sub-Investigator: Renu Regunathan, M.D.         
Sponsors and Collaborators
Anjali Ganda, MD
Investigators
Principal Investigator: Anjali Ganda, M.D., M.S. Columbia University
  More Information

Responsible Party: Anjali Ganda, MD, Assistant Professor of Medicine, Principal Investigator, Columbia University College of Physicians and Surgeons, Columbia University
ClinicalTrials.gov Identifier: NCT01247090     History of Changes
Other Study ID Numbers: AAAE0454 
Study First Received: November 22, 2010
Results First Received: April 4, 2011
Last Updated: July 25, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Columbia University:
hypertension
end stage renal disease
vasopressin
Arginine Vasopressin
AVP
Pitressin®

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016