Myocardial Hemodynamic Effects of Levosimendan - Full Text View

Sponsored by:	University of Utah
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00585104

Purpose

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.

Condition	Intervention	Phase
Heart Failure	Drug: levosimendan	Phase II

MedlinePlus related topics: Heart Failure

Drug Information available for: Levosimendan Simendan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Myocardial Hemodynamic Effects of Levosimendan

Further study details as provided by University of Utah:

Primary Outcome Measures:

For this group of patients with heart failure, we estimate the baseline left ventricular end-diastolic pressure (LVEDP) to be 18 ± 7 mmHg. This slightly lower standard deviation is expected in a heart failure population. [ Time Frame: Sept 2006-Dec 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Levosimendan may lower your blood pressure. Because this study will give a 10-minute infusion of levosimendan, the risk of adverse events would be expected to be lower than those seen with longer infusions. [ Time Frame: Sept 2006-Dec 2008 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	Drug: levosimendan 10-minute infusion

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585104

Locations

United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator:

Andrew Michaels, MD

University of Utah

More Information

Responsible Party:	Univerisity of Utah ( University of Utah )
Study ID Numbers:	IRB00019266, IRB# 00019266
Study First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00585104
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Simendan

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Therapeutic Uses
Physiological Effects of Drugs

Enzyme Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009