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Myocardial Hemodynamic Effects of Levosimendan

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ClinicalTrials.gov Identifier: NCT00585104
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : June 9, 2010
Last Update Posted : May 21, 2013
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Heart Failure Drug: levosimendan Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Myocardial Hemodynamic Effects of Levosimendan
Study Start Date : September 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 1
All randomized patients receive drug.
Drug: levosimendan
10-minute infusion
Other Name: Simdax




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00585104     History of Changes
Other Study ID Numbers: 19266
IRB# 00019266
First Posted: January 3, 2008    Key Record Dates
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