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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.
 
ClinicalTrials.gov Identifier: NCT01346072
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
Kirkwood Adams, University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE April 29, 2011
First Posted Date  ICMJE May 2, 2011
Results First Submitted Date  ICMJE February 24, 2017
Results First Posted Date  ICMJE May 17, 2017
Last Update Posted Date May 17, 2017
Study Start Date  ICMJE April 2011
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2017)
  • Urine Output [ Time Frame: 24 hours ]
    Total urine output for 24 hours following tolvaptan administration
  • Body Weight [ Time Frame: Change over 24 hours ]
    Change in body weight from baseline to 24 hours after tolvaptan administration
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2011)
Urine Output [ Time Frame: 24 hours ]
Total urine output for 24 hours following tolvaptan administration
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2011)
Body weight [ Time Frame: Change over 24 hours ]
Change in body weight from baseline to 24 hours after tolvaptan administration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Using Copeptin to Predict Response to Tolvaptan
Official Title  ICMJE Pilot Study of the Relationship of Ambient Copeptin to the Aquaretic Effects of Tolvaptan in Patients With Heart Failure
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiovascular Diseases
  • Heart Diseases
  • Heart Failure
Intervention  ICMJE Drug: tolvaptan
oral, 30 mg, single dose, one time administration
Other Name: Samsca
Study Arms  ICMJE Tolvaptan
Single arm study
Intervention: Drug: tolvaptan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2015)
21
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2011)
20
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01346072
Other Study ID Numbers  ICMJE TOLCOPEP11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kirkwood Adams, University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Otsuka America Pharmaceutical
Investigators  ICMJE
Principal Investigator: Kirkwood F Adams, MD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP