Trial Outcomes & Findings for Pilot Study of Using Copeptin to Predict Response to Tolvaptan (NCT NCT01346072)
NCT ID: NCT01346072
Last Updated: 2017-05-17
Results Overview
Total urine output for 24 hours following tolvaptan administration
COMPLETED
PHASE4
21 participants
24 hours
2017-05-17
Participant Flow
100 patients were screened in two periods approximately six months each in duration at a dedicated Heart Failure Clinic at the University of North Carolina Chapel Hill. 43 patients met inclusion/exclusion criteria and had a blood sample sent for copeptin testing. Twenty-one patients were enrolled in the hospital phase of the study.
Blinded copeptin results were reviewed in 43 patients for participation in the hospital phase. 11 patients were selected by targeting the upper quartile of baseline copetin and 10 patients by targeting the lower quartile of screening copeptin levels. A total of 21 patients were enrolled in hospital phase.
Participant milestones
| Measure |
Tolvaptan High Copeptin
Tolvaptan: oral, 30 mg, single dose, one time administration
High Copeptin ≥ 10 pmol/L at baseline
|
Tolvaptan Low Copeptin
Tolvaptan: oral, 30 mg, single dose, one time administration
Low Copeptin \< 10 pmol/L at baseline
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
10
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of Using Copeptin to Predict Response to Tolvaptan
Baseline characteristics by cohort
| Measure |
Tolvaptan High Copeptin
n=10 Participants
Tolvaptan: oral, 30 mg, single dose, one time administration
High Copeptin ≥ 10 pmol/L at baseline
|
Tolvaptan Low Copeptin
n=10 Participants
Tolvaptan: oral, 30 mg, single dose, one time administration
Low Copeptin \< 10 pmol/L at baseline
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 11 • n=5 Participants
|
59 years
STANDARD_DEVIATION 13 • n=7 Participants
|
60 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
LVEF
|
23 %
STANDARD_DEVIATION 6.0 • n=5 Participants
|
31 %
STANDARD_DEVIATION 11 • n=7 Participants
|
27 %
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Baseline Copeptin
|
20.5 pmol/L
STANDARD_DEVIATION 8.7 • n=5 Participants
|
5.7 pmol/L
STANDARD_DEVIATION 1.9 • n=7 Participants
|
13.1 pmol/L
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Serum Creatinine
|
1.18 mg/dL
STANDARD_DEVIATION 0.23 • n=5 Participants
|
1.03 mg/dL
STANDARD_DEVIATION 0.35 • n=7 Participants
|
1.10 mg/dL
STANDARD_DEVIATION 0.30 • n=5 Participants
|
|
Serum Sodium
|
141.1 mEq/L
STANDARD_DEVIATION 2.28 • n=5 Participants
|
140.8 mEq/L
STANDARD_DEVIATION 3.46 • n=7 Participants
|
141.0 mEq/L
STANDARD_DEVIATION 2.86 • n=5 Participants
|
|
Total Daily Dose of Loop Diuretic
|
124 mg
STANDARD_DEVIATION 104 • n=5 Participants
|
47 mg
STANDARD_DEVIATION 46 • n=7 Participants
|
84 mg
STANDARD_DEVIATION 86 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: All patients in the Low Copeptin group were included in the analysis. One patient in the High Copeptin group had reduced renal function at baseline versus screening and transient hypovolemia during hospitalization indicative of volume depletion. This patient was excluded prior to review of blinded copeptin results and study data analysis.
Total urine output for 24 hours following tolvaptan administration
Outcome measures
| Measure |
Tolvaptan High Copeptin
n=10 Participants
Tolvaptan: oral, 30 mg, single dose, one time administration
High Copeptin ≥ 10 pmol/L at baseline
|
Tolvaptan Low Copeptin
n=10 Participants
Tolvaptan: oral, 30 mg, single dose, one time administration
Low Copeptin \< 10 pmol/L at baseline
|
|---|---|---|
|
Urine Output
|
6498 mL
Standard Deviation 2328
|
5784 mL
Standard Deviation 1835
|
PRIMARY outcome
Timeframe: Change over 24 hoursPopulation: All patients in the Low Copeptin group were included in the analysis. One patient in the High Copeptin group had reduced renal function at baseline versus screening and transient hypovolemia during hospitalization indicative of volume depletion. This patient was excluded prior to review of blinded copeptin results and study data analysis.
Change in body weight from baseline to 24 hours after tolvaptan administration
Outcome measures
| Measure |
Tolvaptan High Copeptin
n=10 Participants
Tolvaptan: oral, 30 mg, single dose, one time administration
High Copeptin ≥ 10 pmol/L at baseline
|
Tolvaptan Low Copeptin
n=10 Participants
Tolvaptan: oral, 30 mg, single dose, one time administration
Low Copeptin \< 10 pmol/L at baseline
|
|---|---|---|
|
Body Weight
|
-1.3 Kg
Standard Deviation 1.0
|
-0.4 Kg
Standard Deviation 1.0
|
Adverse Events
Tolvaptan High Copeptin
Tolvaptan Low Copeptin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kirkwood F. Adams, Jr., MD
University of North Carolina Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60