Pilot Study of Using Copeptin to Predict Response to Tolvaptan

This study has been completed.
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Kirkwood Adams, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
First received: April 29, 2011
Last updated: May 19, 2015
Last verified: May 2015

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: 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

Enrollment: 21
Study Start Date: April 2011
Study Completion Date: December 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm study
Drug: tolvaptan
oral, 30 mg, single dose, one time administration
Other Name: Samsca


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

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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01346072

United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Otsuka America Pharmaceutical
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: May 19, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Failure
Heart Diseases

ClinicalTrials.gov processed this record on October 09, 2015