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Pilot Study of Using Copeptin to Predict Response to Tolvaptan

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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cardiovascular Diseases
Heart Diseases
Heart Failure
Intervention Drug: tolvaptan
Enrollment 21
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Tolvaptan High Copeptin Tolvaptan Low Copeptin
Hide Arm/Group Description

Tolvaptan: oral, 30 mg, single dose, one time administration

High Copeptin ≥ 10 pmol/L at baseline

Tolvaptan: oral, 30 mg, single dose, one time administration

Low Copeptin < 10 pmol/L at baseline

Period Title: Overall Study
Started 11 10
Completed 11 10
Not Completed 0 0
Arm/Group Title Tolvaptan High Copeptin Tolvaptan Low Copeptin Total
Hide Arm/Group Description

Tolvaptan: oral, 30 mg, single dose, one time administration

High Copeptin ≥ 10 pmol/L at baseline

Tolvaptan: oral, 30 mg, single dose, one time administration

Low Copeptin < 10 pmol/L at baseline

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
All patients in Low Copeptin group were included in analysis. One patient in 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 for a final N of 20.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  70.0%
7
  70.0%
14
  70.0%
>=65 years
3
  30.0%
3
  30.0%
6
  30.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
60  (11) 59  (13) 60  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
5
  50.0%
6
  60.0%
11
  55.0%
Male
5
  50.0%
4
  40.0%
9
  45.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  10.0%
1
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  70.0%
4
  40.0%
11
  55.0%
White
3
  30.0%
5
  50.0%
8
  40.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
LVEF  
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 10 participants 10 participants 20 participants
23  (6.0) 31  (11) 27  (9.6)
Baseline Copeptin  
Mean (Standard Deviation)
Unit of measure:  pmol/L
Number Analyzed 10 participants 10 participants 20 participants
20.5  (8.7) 5.7  (1.9) 13.1  (9.7)
Serum Creatinine  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 10 participants 10 participants 20 participants
1.18  (0.23) 1.03  (0.35) 1.10  (0.30)
Serum Sodium  
Mean (Standard Deviation)
Unit of measure:  mEq/L
Number Analyzed 10 participants 10 participants 20 participants
141.1  (2.28) 140.8  (3.46) 141.0  (2.86)
Total Daily Dose of Loop Diuretic  
Mean (Standard Deviation)
Unit of measure:  Mg
Number Analyzed 10 participants 10 participants 20 participants
124  (104) 47  (46) 84  (86)
1.Primary Outcome
Title Urine Output
Hide Description Total urine output for 24 hours following tolvaptan administration
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tolvaptan High Copeptin Tolvaptan Low Copeptin
Hide Arm/Group Description:

Tolvaptan: oral, 30 mg, single dose, one time administration

High Copeptin ≥ 10 pmol/L at baseline

Tolvaptan: oral, 30 mg, single dose, one time administration

Low Copeptin < 10 pmol/L at baseline

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: mL
6498  (2328) 5784  (1835)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tolvaptan High Copeptin, Tolvaptan Low Copeptin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.853
Comments [Not Specified]
Method Wilcoxon Two-Sample Test
Comments Wilcoxon Two Sample Test was used with Exact Test two sided p value reported
2.Primary Outcome
Title Body Weight
Hide Description Change in body weight from baseline to 24 hours after tolvaptan administration
Time Frame Change over 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Tolvaptan High Copeptin Tolvaptan Low Copeptin
Hide Arm/Group Description:

Tolvaptan: oral, 30 mg, single dose, one time administration

High Copeptin ≥ 10 pmol/L at baseline

Tolvaptan: oral, 30 mg, single dose, one time administration

Low Copeptin < 10 pmol/L at baseline

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: Kg
-1.3  (1.0) -0.4  (1.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tolvaptan High Copeptin, Tolvaptan Low Copeptin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method Wilcoxon Two-Sample Test
Comments Wilcoxon Two Sample Test was used with Exact Test two sided p value reported
Time Frame 24 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tolvaptan High Copeptin Tolvaptan Low Copeptin
Hide Arm/Group Description

Tolvaptan: oral, 30 mg, single dose, one time administration

High Copeptin ≥ 10 pmol/L at baseline

Tolvaptan: oral, 30 mg, single dose, one time administration

Low Copeptin < 10 pmol/L at baseline

All-Cause Mortality
Tolvaptan High Copeptin Tolvaptan Low Copeptin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
Hide Serious Adverse Events
Tolvaptan High Copeptin Tolvaptan Low Copeptin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tolvaptan High Copeptin Tolvaptan Low Copeptin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kirkwood F. Adams, Jr., MD
Organization: University of North Carolina Chapel Hill
Phone: 919-966-2877
EMail: kfa@med.unc.edu
Layout table for additonal information
Responsible Party: Kirkwood Adams, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01346072    
Other Study ID Numbers: TOLCOPEP11
First Submitted: April 29, 2011
First Posted: May 2, 2011
Results First Submitted: February 24, 2017
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017