Myocardial Hemodynamic Effects of Levosimendan

NCT00585104 | Completed Phase 2 Results DMC

• 2 other identifiers: 19266IRB# 00019266
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 30-minutes after levosimendan started.

Study Arms (1)

1

EXPERIMENTAL

All randomized patients receive drug.

Drug: levosimendan

Interventions

levosimendan DRUG

10-minute infusion

Also known as: Simdax

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under age 18

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Simendan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Of the ten (10) patients enrolled, only 6 patients completed the study protocol for which we collected data. The data is insufficient to provide a formal summary for publication.

Results Point of Contact

• Title: Andrew D. Michaels, MD
• Organization: University of Utah Health Sciences Center

Andrew.Michaels@hsc.utah.edu

(801) 585-5971

Study Officials

• Andrew Michaels, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 3, 2008
• Study Start: September 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 21, 2013
• Results First Posted: June 9, 2010

Record last verified: 2013-05

Locations

US (1)