Trial · NCT01584557
Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management
NCT01584557, Phase 3, Completed, Cardiovascular Clinical Sciences Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management. Trials, record NCT01584557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01584557
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management
- NCT number
- NCT01584557
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 250 participants, actual
- Lead sponsor
- Cardiovascular Clinical Sciences Inc
- Conditions
- Heart Failure
- Interventions
- Tolvaptan or Samsca, placebo or sugar pill
- First posted
- 2012-04-25
- Last updated
- 2016-09-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To evaluate the short term efficacy and safety of tolvaptan in subjects hospitalized for worsening heart failure who have volume overload and one of the following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy. | 8 and 16 hours | The primary variable for assessing efficacy will be self-assessed 7-point dyspnea score at 8 and 16 hours. |
| Secondary | Change from baseline in body weight measured daily while hospitalized up to 7 days. | up to 7 days | Change from baseline in body weight measured daily while hospitalized up to 7 days. |
| Secondary | Diuretic dose measured daily while hospitalized up to 7 days. | up to 7 days. | Diuretic dose measured daily while hospitalized up to 7 days. |
| Secondary | Change from baseline in estimated glomerular filtration rate (eGFR) at discharge or day 7, whichever comes first. | at discharge or day 7, whichever comes first. | Change from baseline in estimated glomerular filtration rate (eGFR) at discharge or day 7, whichever comes first. |
| Secondary | Days alive and out of the hospital over 30 days | 30 days. | Days alive and out of the hospital over 30 days |
| Secondary | Change from baseline in cognitive function at 48 hours or discharge, whichever comes first | at 48 hours or dischage, whichever comes first | Change from baseline in cognitive function at 48 hours or discharge, whichever comes first |
| Secondary | Re-hospitalization for worsening heart failure or death at 30 days | 30 days. | Re-hospitalization for worsening heart failure or death at 30 days |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28302292 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01584557
GET https://conductscience.org/api/trials/v1/NCT01584557/registered