Back to resultsPilot Study of Using Copeptin to Predict Response to Tolvaptan
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Heart Failure
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
tolvaptan
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Diseases focused on measuring tolvaptan, copeptin, heart failure, vasopressin antagonist
Eligibility Criteria
Inclusion Criteria:
- 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
- Left ventricular ejection fraction ≤ 45% as documented by quantitative assessment by an accepted imaging technique within one year of screening
- Meet baseline copeptin criteria for entry
- Currently taking a diuretic (with diuretic defined as any loop or thiazide diuretic or aldosterone antagonist at any dose)
Exclusion Criteria:
- Current New York Heart Association Functional Class IV heart failure
- Patients who are felt to be volume depleted based on clinical examination or need to reduce diuretic administration
- Presence of clinical contraindications to tolvaptan
- Episode of acute myocardial infarction or acute coronary syndrome within the past 3 months
- Cardiovascular surgical procedure within the past 4 weeks
- CHF due to uncorrected thyroid disease, active myocarditis, or known amyloid cardiomyopathy.
- History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
- Chronic uncontrolled diabetes mellitus as determined by the investigator.
- Supine systolic arterial blood pressure < 90 mmHg at screening
- Serum creatinine > 3.5 mg/dL at screening
- Serum potassium > 5.5 mEq/L or < 3.5 mEq/L at screening
- 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
Sites / Locations
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Tolvaptan
Arm Description
Single arm study
Outcomes
Primary Outcome Measures
Urine Output
Total urine output for 24 hours following tolvaptan administration
Body Weight
Change in body weight from baseline to 24 hours after tolvaptan administration
Secondary Outcome Measures
Full Information
NCT ID
NCT01346072
First Posted
April 29, 2011
Last Updated
April 11, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Otsuka America Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT01346072
Brief Title
Pilot Study of Using Copeptin to Predict Response to Tolvaptan
Official Title
Pilot Study of the Relationship of Ambient Copeptin to the Aquaretic Effects of Tolvaptan in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Otsuka America Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Heart Failure
Keywords
tolvaptan, copeptin, heart failure, vasopressin antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tolvaptan
Arm Type
Other
Arm Description
Single arm study
Intervention Type
Drug
Intervention Name(s)
tolvaptan
Other Intervention Name(s)
Samsca
Intervention Description
oral, 30 mg, single dose, one time administration
Primary Outcome Measure Information:
Title
Urine Output
Description
Total urine output for 24 hours following tolvaptan administration
Time Frame
24 hours
Title
Body Weight
Description
Change in body weight from baseline to 24 hours after tolvaptan administration
Time Frame
Change over 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Left ventricular ejection fraction ≤ 45% as documented by quantitative assessment by an accepted imaging technique within one year of screening
Meet baseline copeptin criteria for entry
Currently taking a diuretic (with diuretic defined as any loop or thiazide diuretic or aldosterone antagonist at any dose)
Exclusion Criteria:
Current New York Heart Association Functional Class IV heart failure
Patients who are felt to be volume depleted based on clinical examination or need to reduce diuretic administration
Presence of clinical contraindications to tolvaptan
Episode of acute myocardial infarction or acute coronary syndrome within the past 3 months
Cardiovascular surgical procedure within the past 4 weeks
CHF due to uncorrected thyroid disease, active myocarditis, or known amyloid cardiomyopathy.
History of primary significant liver disease or acute hepatic failure, as defined by the investigator.
Chronic uncontrolled diabetes mellitus as determined by the investigator.
Supine systolic arterial blood pressure < 90 mmHg at screening
Serum creatinine > 3.5 mg/dL at screening
Serum potassium > 5.5 mEq/L or < 3.5 mEq/L at screening
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirkwood F Adams, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
12. IPD Sharing Statement
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Pilot Study of Using Copeptin to Predict Response to Tolvaptan
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