Phase 2 Completed N=10 Treatment

Myocardial Hemodynamic Effects of Levosimendan

Source: ClinicalTrials.gov NCT00585104 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2010

Primary outcomePrimary: Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter. — 5.67 mmHg

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter.	5.67	—

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

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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. Informational only — not medical advice.