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Sponsor decided to quit funding before any enrollments
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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | INDUSTRY |
| Thermo Fisher Scientific, Inc | INDUSTRY |
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Patients being hospitalized for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo, based on the level of copeptin measured in their bloodstream. Patients with high copeptin levels will be able to participate in the trial, patients with low levels will be excluded. Patients being admitted to the observation unit for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo without consideration of the copeptin level. The hypothesis is that patients receiving tolvaptan will have better improvement of shortness of breath than those receiving placebo, within 9 hours of drug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard therapy plus Tolvaptan | Experimental | Patient in the interventional group will receive tolvaptan in addition to standard therapy |
|
| Standard therapy plus placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan | Drug | Tolvaptan 30 mg. tablet for subjects enrolled prior to first 8 hours of coming to an emergency department. Repeated daily up to 5th day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea | Dyspnea will be evaluated at 9 hours | 9 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | The length of hospitalization will be compared between the placebo and interventional cohorts | during hospitalizaton |
| Rehospitalization | The number and length of re-hospitalizations will be compared between the placebo and interventional cohorts |
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Inclusion Criteria:
Inpatient Hospitalized Inclusion Only:
Co-peptin level > 27 pmol/L
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan S Maisel, MD | Principal Investigator |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney 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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|
| placebo | Drug | Patient in the placebo group will receive tolvaptan in addition to standard therapy |
|
| 30 days |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |