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| ID | Type | Description | Link |
|---|---|---|---|
| IRB# 00019266 |
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This study will test the hypothesis that mechanical efficiency as measured by pressure-volume loop assessment should improve during short-term treatment with intravenous levosimendan.
Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which has been shown to have beneficial hemodynamic effects in patients with decompensated congestive heart failure (CHF). Levosimendan is a new calcium sensitizer that binds to troponin C. This agent is approved in Europe for treatment of heart failure patients. In the United States, this agent is currently under phase III investigation for intravenous treatment of patients with acutely decompensated HF who have dyspnea at rest or with minimal activity. Levosimendan has been studied in these patients with acute HF and is considered experimental in the United States for this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | All randomized patients receive drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levosimendan | Drug | 10-minute infusion |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter. | Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis. | From baseline to 30-minutes after levosimendan started. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Michaels, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levosimendan, Compare Heart Function and Metabolism | All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levosimendan, Compare Heart Function and Metabolism | All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter. | Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis. | Ten patients were enrolled. Complete data was available in 6 patients. The primary endpoint was change in left ventricular end diastolic pressure (LVEDP) from baseline to 30-minutes after starting levosimendan. An Intent to Treat (ITT) analysis was performed. | Posted | Mean | Standard Deviation | mmHg | From baseline to 30-minutes after levosimendan started. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levosimendan, Compare Heart Function and Metabolism | All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan. |
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Of the ten (10) patients enrolled, only 6 patients completed the study protocol for which we collected data. The data is insufficient to provide a formal summary for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew D. Michaels, MD | University of Utah Health Sciences Center | (801) 585-5971 | Andrew.Michaels@hsc.utah.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077464 | Simendan |
| ID | Term |
|---|---|
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D011724 | Pyridazines |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Left Ventricular End Diastolic Pressure (LVEDP) | Mean | Standard Deviation | mmHg |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 10 |
| 0 |
| 10 |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |