Myocardial Hemodynamic Effects of Levosimendan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00585104
First received: December 21, 2007
Last updated: May 14, 2013
Last verified: May 2013
  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: 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. ] [ Designated as safety issue: No ]
    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

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

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00585104     History of Changes
Other Study ID Numbers: 19266, IRB# 00019266
Study First Received: December 21, 2007
Results First Received: February 11, 2010
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 22, 2014