Heart Failure
Conditions
Brief summary
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.
Interventions
DRUGlevosimendan
10-minute infusion
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients will have either a sinus or paced atrial rhythm with atrioventricular synchrony on electrocardiography * All patients will have a history of heart failure diagnosed clinically with history of prior symptoms or signs of heart failure with at least one of the following symptoms within the past month: dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, pedal edema * In asymptomatic patients, patients may be enrolled if they have at least one of the following clinical signs of heart failure: left ventricular third and/or fourth heart sound, jugular venous pressure \>7 mmHg, sustained left ventricular impulse, or pulmonary congestion on auscultation * all patients will have echocardiographic evidence of left ventricular dysfunction
Exclusion criteria
* Under age 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter. | From baseline to 30-minutes after levosimendan started. | Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Levosimendan, Compare Heart Function and Metabolism |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age Continuous | 59 years STANDARD_DEVIATION 13.6 |
| Left Ventricular End Diastolic Pressure (LVEDP) | 18 mmHg STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: From baseline to 30-minutes after levosimendan started.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Levosimendan, Compare Heart Function and Metabolism | Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter. | 5.67 mmHg | Standard Deviation 4.32 |