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
Public ClinicalTrials.gov record NCT01584557. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is 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. The primary variable for assessing efficacy will be self-assessed 7-point dyspnea score at 8 and 16 hours.
Study identification
- NCT ID
- NCT01584557
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2012 (Type not available)
- Primary completion
- Jul 2016 (Actual)
- Completion
- Aug 2016 (Actual)
- Last update posted
- Sep 27, 2016
2012 – 2016
United States locations
- U.S. sites
- 37
- U.S. states
- 21
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| The Heart Center Research | Huntsville | Alabama | 35801 | — |
| Greater Los Angeles VA Medical Center | Los Angeles | California | 90073 | — |
| University of Florida Health Science Ctr. Jacksonville | Jacksonville | Florida | 32209 | — |
| MIMA Century Research Associates | Melbourne | Florida | 32901 | — |
| Jackson Memorial Hospital | Miami | Florida | 33136 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| University Cardiology Associates, LLC | Augusta | Georgia | 30901 | — |
| Mercer University School of Medicine | Macon | Georgia | 31201 | — |
| Advocate Medical Group - Oakbrook | Naperville | Illinois | 60540 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| St. Vincent Medical Group | Indianapolis | Indiana | 46260 | — |
| CardioSpecialists Group | Munster | Indiana | 46321 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Advanced Cardiovascular Specialists | Shreveport | Louisiana | 71135 | — |
| Louisiana Heart Center and Research | Slidell | Louisiana | 70458 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | — |
| Crittenton Hospital Medical Center | Rochester | Michigan | 48307 | — |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | — |
| Bryan Heart Institute | Lincoln | Nebraska | 68506 | — |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | — |
| Caromont Heart/Gaston Memorial Hospital | Gastonia | North Carolina | 28054 | — |
| Duke Cardiology of Lumberton Research/Southeastern Regional Medical Cente | Lumberton | North Carolina | 28358 | — |
| Akron General Medical Center | Akron | Ohio | 44307 | — |
| University of Cincinnati | Cincinnatti | Ohio | 45267 | — |
| Dayton Heart Center | Dayton | Ohio | 45414 | — |
| The Sisters of Mercy of Hamilton, Ohio dba Mercy Hospital Fairfield | Fairfield | Ohio | 45014 | — |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19102 | — |
| Memorial Hospital of RI | Pawtucket | Rhode Island | 02860 | — |
| The Miriam Hosptial | Providence | Rhode Island | 02906 | — |
| University of Texas Health Science Center | Houston | Texas | 77030 | — |
| The Heart Hospital Baylor Plano - Research Insititute | Plano | Texas | 75024 | — |
| CV Group Central Lynchburg/Stroobants Heart Center | Lynchburg | Virginia | 25401 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01584557, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 27, 2016 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01584557 live on ClinicalTrials.gov.