Back to resultsMyocardial Hemodynamic Effects of Levosimendan
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
levosimendan
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility 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
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
All randomized patients receive drug.
Outcomes
Primary Outcome Measures
Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter.
Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00585104
Brief Title
Myocardial Hemodynamic Effects of Levosimendan
Official Title
Myocardial Hemodynamic Effects of Levosimendan
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
All randomized patients receive drug.
Intervention Type
Drug
Intervention Name(s)
levosimendan
Other Intervention Name(s)
Simdax
Intervention Description
10-minute infusion
Primary Outcome Measure Information:
Title
Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter.
Description
Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis.
Time Frame
From baseline to 30-minutes after levosimendan started.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Michaels, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
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Myocardial Hemodynamic Effects of Levosimendan
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