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Myocardial Hemodynamic Effects of Levosimendan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585104
First Posted: January 3, 2008
Last Update Posted: May 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Utah
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Myocardial Hemodynamic Effects of Levosimendan

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter. [ Time Frame: From baseline to 30-minutes after levosimendan started. ]
    Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis.


Enrollment: 10
Study Start Date: September 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All randomized patients receive drug.
Drug: levosimendan
10-minute infusion
Other Name: Simdax

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: University of Utah
ClinicalTrials.gov Identifier: NCT00585104     History of Changes
Other Study ID Numbers: 19266
IRB# 00019266
First Submitted: December 21, 2007
First Posted: January 3, 2008
Results First Submitted: February 11, 2010
Results First Posted: June 9, 2010
Last Update Posted: May 21, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Simendan
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs