Working… Menu

Pilot Study of Using Copeptin to Predict Response to Tolvaptan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01346072
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Kirkwood Adams, University of North Carolina, Chapel Hill

Brief Summary:

This pilot 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. The study will enroll stable outpatients with CHF with reduced LVEF (≤45) selected by targeting upper and lower quartile copeptin levels at screening (10 each). The treatment phase of the study will be a prospective, single-arm, open label protocol. All patients will receive active therapy consisting of a single oral dose of 30 mg of tolvaptan with body weight, fluid intake, and urine output monitored in a research unit for 24 hours.

For analysis of study endpoints, patients in the single intervention arm will be stratified by a prospectively determined cut-point of copeptin level into two groups (≥10 versus <10 pmol/L). The copeptin level used for the two group stratification will be the blinded copeptin value obtained at baseline from the hospital phase prior to administration of tolvaptan.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Heart Diseases Heart Failure Drug: tolvaptan Phase 4

Detailed Description:

The study screening strategy will be designed to enroll an enriched patient population by identifying patients at the high or low end of the spectrum of copeptin levels for outpatients with stable heart failure. This will be accomplished by blinded review of copeptin levels obtained during screening.

The primary endpoints for analysis will be 24 hour urine output and the change in body weight over 24 hours during the inpatient stay.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Tolvaptan

Arm Intervention/treatment
Single arm study
Drug: tolvaptan
oral, 30 mg, single dose, one time administration
Other Name: Samsca

Primary Outcome Measures :
  1. Urine Output [ Time Frame: 24 hours ]
    Total urine output for 24 hours following tolvaptan administration

  2. Body Weight [ Time Frame: Change over 24 hours ]
    Change in body weight from baseline to 24 hours after tolvaptan administration

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01346072

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Kirkwood F Adams, MD University of North Carolina, Chapel Hill
Layout table for additonal information
Responsible Party: Kirkwood Adams, Associate Professor of Medicine and Radiology, University of North Carolina, Chapel Hill Identifier: NCT01346072    
Other Study ID Numbers: TOLCOPEP11
First Posted: May 2, 2011    Key Record Dates
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017
Last Verified: April 2017
Keywords provided by Kirkwood Adams, University of North Carolina, Chapel Hill:
heart failure
vasopressin antagonist
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Insipidus
Heart Failure
Cardiovascular Diseases
Heart Diseases
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs