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This study will look at how a single dose of study medication (tolvaptan) versus an inactive sugar pill (placebo) effect pressures in the heart in patients with congestive heart failure. Higher than normal pressures can be related to symptoms of heart failure (shortness of breath, fatigue, etc.).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tolvaptan | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in heart pressures (PCWP) at 3 to 8 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change in heart function measurements (CI, SVR, PVR, RAP) at 3 to 8 hours post-dose | ||
| Change in urine output and free water clearance | ||
| Change from baseline in urine osmolality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Udelson, MD | Cardiovascular Clinical Studies and Tufts/New England Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oracle Research, A Div of the Heart Center | Huntsville | Alabama | 35801 | United States | ||
| Merced Heart Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19095138 | Derived | Hiukka A, Westerbacka J, Leinonen ES, Watanabe H, Wiklund O, Hulten LM, Salonen JT, Tuomainen TP, Yki-Jarvinen H, Keech AC, Taskinen MR. Long-term effects of fenofibrate on carotid intima-media thickness and augmentation index in subjects with type 2 diabetes mellitus. J Am Coll Cardiol. 2008 Dec 16;52(25):2190-7. doi: 10.1016/j.jacc.2008.09.049. | |
| 19007589 |
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| Cmax, tmax, and AUC 12h of tolvaptan in plasma |
| Adverse events, vital signs and clinical labs |
| Merced |
| California |
| 95340 |
| United States |
| Olive View-UCLA Medical Center | Sylmar | California | 91324 | United States |
| Broward General Medical Center | Fort Lauderdale | Florida | 33316 | United States |
| Cardiovascular Center at Shands Jacksonville | Jacksonville | Florida | 32209 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| ACRI | Atlanta | Georgia | 30342 | United States |
| Northwestern University | Chicago | Illinois | 60612 | United States |
| Robert Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Loyola University of Chicago | Maywood | Illinois | 60153 | United States |
| University of Iowa Health Care | Iowa City | Iowa | 52242 | United States |
| Cardiologist Institute | Slidell | Louisiana | 70458 | United States |
| Medical Research Institute Louisiana Heart Hospital | Slidell | Louisiana | 70458 | United States |
| Primary Cardiology Associates | Ayer | Massachusetts | 01432 | United States |
| U-MASS Memorial Medical Center | Worchester | Massachusetts | 01655 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Heart Consultants, PC | Omaha | Nebraska | 68122 | United States |
| University of Medicine and Dentistry | Newark | New Jersey | 07103 | United States |
| UNC Heart Failure Program | Chapel Hill | North Carolina | 27517 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| Cleveland VA Medical Center | Cleveland | Ohio | 44106 | United States |
| Oregon Health Sciences University | Portland | Oregon | 97239 | United States |
| Guthrie Foundation | Syre | Pennsylvania | 18840 | United States |
| Texas Heart Institute | Houston | Texas | 77702 | United States |
| Southeast Texas Clinical Research | Orange | Texas | 77702 | United States |
| Spitalul Clinic Urgenta | Bucharest | 014461 | Romania |
| Institutul de Boli Cardiovasculare | Bucharest | 022322 | Romania |
| Institutul de Boli Cardiovasculare"Prof. Dr. C.C. Illiescu" | Bucharest | Cod 022322 | Romania |
| Institutul Inimii | Judetul Cluj | Cod 400001 | Romania |
| Institutul de Boli Cardiovasculare si Transplant | Judetul Mures | Cod 540136 | Romania |
| Udelson JE, Orlandi C, Ouyang J, Krasa H, Zimmer CA, Frivold G, Haught WH, Meymandi S, Macarie C, Raef D, Wedge P, Konstam MA, Gheorghiade M. Acute hemodynamic effects of tolvaptan, a vasopressin V2 receptor blocker, in patients with symptomatic heart failure and systolic dysfunction: an international, multicenter, randomized, placebo-controlled trial. J Am Coll Cardiol. 2008 Nov 4;52(19):1540-5. doi: 10.1016/j.jacc.2008.08.013. |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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