Myocardial Hemodynamic Effects of Levosimendan

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Drug: levosimendan

• Registration Number: NCT00585104
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-03
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2010-02-11
• Results First Submitted QC: 2010-05-17
• Results First Posted: 2010-06-09
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-14
• Last Update Posted: 2013-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	levosimendan	All randomized patients receive drug.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States