Pilot Study of Using Copeptin to Predict Response to Tolvaptan

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Kirkwood Adams, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01346072
First received: April 29, 2011
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

This study will investigate the association between levels of the peptide copeptin and response to tolvaptan, a drug that blocks the action of the water retaining hormone vasopressin.


Condition Intervention Phase
Cardiovascular Diseases
Heart Diseases
Heart Failure
Drug: tolvaptan
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of the Relationship of Ambient Copeptin to the Aquaretic Effects of Tolvaptan in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Urine output [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Total urine output for 24 hours following tolvaptan administration


Secondary Outcome Measures:
  • Body weight [ Time Frame: Change over 24 hours ] [ Designated as safety issue: No ]
    Change in body weight from baseline to 24 hours after tolvaptan administration


Estimated Enrollment: 20
Study Start Date: April 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tolvaptan
Single arm study
Drug: tolvaptan
oral, 30 mg, single dose, one time administration
Other Name: Samsca

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patients with a history of chronic symptomatic heart failure, defined as dyspnea on exertion or edema, due to cardiac dysfunction, of at least one month's duration
  2. Left ventricular ejection fraction ≤ 45% as documented by quantitative assessment by an accepted imaging technique within one year of screening
  3. Meet baseline copeptin criteria for entry
  4. Currently taking a diuretic (with diuretic defined as any loop or thiazide diuretic or aldosterone antagonist at any dose)

Exclusion Criteria:

  1. Current New York Heart Association Functional Class IV heart failure
  2. Patients who are felt to be volume depleted based on clinical examination or need to reduce diuretic administration
  3. Presence of clinical contraindications to tolvaptan
  4. Episode of acute myocardial infarction or acute coronary syndrome within the past 3 months
  5. Cardiovascular surgical procedure within the past 4 weeks
  6. CHF due to uncorrected thyroid disease, active myocarditis, or known amyloid cardiomyopathy.
  7. History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
  8. Chronic uncontrolled diabetes mellitus as determined by the investigator.
  9. Supine systolic arterial blood pressure < 90 mmHg at screening
  10. Serum creatinine > 3.5 mg/dL at screening
  11. Serum potassium > 5.5 mEq/L or < 3.5 mEq/L at screening
  12. Subjects currently treated with hemofiltration or dialysis

j. Subjects judged by the investigator to be unable to maintain accurate intake and output during their hospitalization related to medical or other problems

  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: NCT01346072

Contacts
Contact: Kirkwood F Adams, MD 919-966-2877

Locations
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Kirkwood F Adams, MD    919-966-2877    kfa@med.unc.edu   
Contact: Herbert Patterson, PharmD    919 962-0072    hpatterson@unc.edu   
Principal Investigator: Kirkwood F Adams, MD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Otsuka America Pharmaceutical
Investigators
Principal Investigator: Kirkwood F Adams, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Kirkwood Adams, Associate Professor of Medicine and Radiology, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01346072     History of Changes
Other Study ID Numbers: TOLCOPEP11
Study First Received: April 29, 2011
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
tolvaptan
copeptin
heart failure
vasopressin antagonist

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 01, 2014