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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

21 participants

Primary outcome timeframe

24 hours

Results posted on

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

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

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=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=99 Participants	7 Participants n=107 Participants	14 Participants n=206 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Age, Continuous	60 years STANDARD_DEVIATION 11 • n=99 Participants	59 years STANDARD_DEVIATION 13 • n=107 Participants	60 years STANDARD_DEVIATION 12 • n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	6 Participants n=107 Participants	11 Participants n=206 Participants
Sex: Female, Male Male	5 Participants n=99 Participants	4 Participants n=107 Participants	9 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	7 Participants n=99 Participants	4 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants	5 Participants n=107 Participants	8 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	10 participants n=99 Participants	10 participants n=107 Participants	20 participants n=206 Participants
LVEF	23 % STANDARD_DEVIATION 6.0 • n=99 Participants	31 % STANDARD_DEVIATION 11 • n=107 Participants	27 % STANDARD_DEVIATION 9.6 • n=206 Participants
Baseline Copeptin	20.5 pmol/L STANDARD_DEVIATION 8.7 • n=99 Participants	5.7 pmol/L STANDARD_DEVIATION 1.9 • n=107 Participants	13.1 pmol/L STANDARD_DEVIATION 9.7 • n=206 Participants
Serum Creatinine	1.18 mg/dL STANDARD_DEVIATION 0.23 • n=99 Participants	1.03 mg/dL STANDARD_DEVIATION 0.35 • n=107 Participants	1.10 mg/dL STANDARD_DEVIATION 0.30 • n=206 Participants
Serum Sodium	141.1 mEq/L STANDARD_DEVIATION 2.28 • n=99 Participants	140.8 mEq/L STANDARD_DEVIATION 3.46 • n=107 Participants	141.0 mEq/L STANDARD_DEVIATION 2.86 • n=206 Participants
Total Daily Dose of Loop Diuretic	124 mg STANDARD_DEVIATION 104 • n=99 Participants	47 mg STANDARD_DEVIATION 46 • n=107 Participants	84 mg STANDARD_DEVIATION 86 • n=206 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: 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

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 hours

Change in body weight from baseline to 24 hours after tolvaptan administration

Outcome measures

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tolvaptan Low Copeptin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: 919-966-2877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60