Phase 2
N=10
Myocardial Hemodynamic Effects of Levosimendan
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00585104 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2010
Primary outcome: Primary: Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter. — 5.67 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- levosimendan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter. |
5.67 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00585104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.