Trial · NCT02476409
Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders
NCT02476409, Phase 4, Completed, University of North Carolina, Chapel Hill; results first posted 2022-05-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders. Trials, record NCT02476409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02476409
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders
- NCT number
- NCT02476409
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 40 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Congestive Heart Failure
- Interventions
- tolvaptan, Placebo
- First posted
- 2015-06-19
- Last updated
- 2022-05-05
- Results first posted
- 2022-05-05
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Body Weight at 48 Hours | Baseline, Day 3 (48 hours) | The primary endpoint for the study will be change in body weight between patients randomized to tolvaptan versus placebo from baseline to 48 hours |
| Primary | Change in Body Weight at 48 Hours Stratified by Copeptin | Baseline, Day 3 (48 hours) | The primary endpoint for the study will be change in body weight between patients randomized to tolvaptan versus placebo from baseline to 48 hours with stratification for baseline copeptin level |
| Secondary | Changes in Visual Analog Scale - Patient Dyspnea | Baseline, Day 3 (48 hours) | Changes in patient reported dyspnea scale from baseline to 48 hours based on the visual analog scale. Visual Analog Scale (VAS) - Patient Dyspnea has a minimum value of 0 and a maximum value of 100. Higher scores mean a better outcome. |
| Secondary | Change in Loop Diuretic Dose (Furosemide Milligram Equivalents) at 48 Hours | Day 3 (48 hours) | Change in loop diuretic dose at 48 hours where doses of loop diuretic are expressed as furosemide milligram equivalents based on standard conversions of bumetanide and torsemide doses to milligram equivalents of furosemide. The formula for the conversion of doses of loop diuretics were standardized to milligram equivalents of furosemide based on 40 milligrams of furosemide for each 1 milligram of bumetanide and 2 milligrams of furosemide for each 1 milligram of torsemide. |
| Secondary | Number of Participants With a Decrease in Loop Diuretic Dosing at 48 Hours | Day 3 (48 hours) | Number of participants with a decrease in loop diuretic diuretic dosing at 48 hours in the Tolvaptan group and the Placebo group. |
| Secondary | Change in Loop Diuretic Score Defined Based on Change in Loop Diuretic Use | Day 3 (48 hours) | Change in loop diuretic score defined by change in loop diuretic use at Visit 2. The change in loop diuretic score endpoint was calculated as follows: patients having an increase in loop diuretic use at Visit 2 were given a score of 2, patients with no change a score of 0, and patients with a decrease in loop use at Visit 2 were given a score of -1. Increases in loop diuretic use were given a higher weighting to account for their reflection of treatment failure. |
| Secondary | Change in Body Weight at Day 8 | Baseline, 8 days | Change in body weight at 8 days will be analyzed in a similar fashion to the change in body weight at 48 hours |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Body Weight at 48 Hours | Baseline, Day 3 (48 hours) | One participant in the Tolvaptan group missed study Visit 2 (Day 3 (48 hours)) due to adverse weather. This participant subsequently attended study Visit 3 (Day 8) to complete the study. Thus data were available on 18 of the 19 patients in the Tolvaptan group for this endpoint at study Visit 2 (Day 3 (48 hours)). | pounds | MEAN |
| PRIMARY | Change in Body Weight at 48 Hours Stratified by Copeptin | Baseline, Day 3 (48 hours) | One participant in the High Copeptin - Tolvaptan group missed study Visit 2 (Day 3 (48 hours)) due to adverse weather. Thus data were available on 11 of the 12 patients in the High Copeptin - Tolvaptan group for this endpoint. | pounds | MEAN |
| SECONDARY | Changes in Visual Analog Scale - Patient Dyspnea | Baseline, Day 3 (48 hours) | One participant in the Tolvaptan group missed study Visit 2 (Day 3 (48 hours)) due to adverse weather. This participant subsequently attended study Visit 3 (Day 8) to complete the study. Thus data were available on 18 of the 19 patients in the Tolvaptan group for this endpoint at study Visit 2 (Day 3 (48 hours)). | score on a scale | MEAN |
| SECONDARY | Change in Loop Diuretic Dose (Furosemide Milligram Equivalents) at 48 Hours | Day 3 (48 hours) | furosemide milligram equivalents | MEAN | |
| SECONDARY | Number of Participants With a Decrease in Loop Diuretic Dosing at 48 Hours | Day 3 (48 hours) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Loop Diuretic Score Defined Based on Change in Loop Diuretic Use | Day 3 (48 hours) | units on a scale | MEAN | |
| SECONDARY | Change in Body Weight at Day 8 | Baseline, 8 days | pounds | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Body Weight at 48 Hours | Tolvaptan | -3.3 | Standard Deviation 4.4 | pounds | |
| Change in Body Weight at 48 Hours | Placebo | -0.8 | Standard Deviation 3.5 | pounds | |
| Change in Body Weight at 48 Hours Stratified by Copeptin | High Copeptin - Tolvaptan | -2.9 | Standard Deviation 5.3 | pounds | |
| Change in Body Weight at 48 Hours Stratified by Copeptin | High Copeptin - Placebo | 0.3 | Standard Deviation 3.7 | pounds | |
| Change in Body Weight at 48 Hours Stratified by Copeptin | Low Copeptin - Tolvaptan | -3.8 | Standard Deviation 3.0 | pounds | |
| Change in Body Weight at 48 Hours Stratified by Copeptin | Low Copeptin - Placebo | -2.4 | Standard Deviation 2.7 | pounds | |
| Changes in Visual Analog Scale - Patient Dyspnea | Tolvaptan | 21 | Standard Deviation 23 | score on a scale | |
| Changes in Visual Analog Scale - Patient Dyspnea | Placebo | 15 | Standard Deviation 22 | score on a scale | |
| Change in Loop Diuretic Dose (Furosemide Milligram Equivalents) at 48 Hours | Tolvaptan | -57 | Standard Deviation 94 | furosemide milligram equivalents | |
| Change in Loop Diuretic Dose (Furosemide Milligram Equivalents) at 48 Hours | Placebo | -11 | Standard Deviation 79 | furosemide milligram equivalents |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tolvaptan | 19 | |
| Overall Study | STARTED | Placebo | 21 | |
| Overall Study | COMPLETED | Tolvaptan | 19 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Tolvaptan | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Volume Depletion | Cardiac disorders | Tolvaptan | 1 | 19 | 1 |
| serious | Volume Depletion | Cardiac disorders | Placebo | 1 | 21 | 1 |
| serious | Worsening Heart Failure | Cardiac disorders | Tolvaptan | 4 | 19 | 4 |
| serious | Worsening Heart Failure | Cardiac disorders | Placebo | 3 | 21 | 3 |
| serious | Chronic Obstructive Lung Disease | Respiratory, thoracic and mediastinal disorders | Tolvaptan | 1 | 19 | 1 |
| serious | Chronic Obstructive Lung Disease | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 21 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tolvaptan | 0 | 19 |
| Total, all-cause mortality | Placebo | 0 | 21 |
| Total, other adverse events | Tolvaptan | 0 | 19 |
| Total, other adverse events | Placebo | 0 | 21 |
| Total, serious adverse events | Tolvaptan | 6 | 19 |
| Total, serious adverse events | Placebo | 4 | 21 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tolvaptan vs Placebo: Number of Participants With a Decrease in Loop Diuretic Dosing at 48 Hours | Trial comparisons |
| Tolvaptan vs Placebo: deaths from any cause | Trial comparisons |
| Tolvaptan vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02476409
GET https://conductscience.org/api/trials/v1/NCT02476409/registered