Levosimendan Efficacy Assessment by Cardiopulmonary Exercise Test (CPET)

NCT02261948 | Completed Phase 4 Results

• 1 other identifier: CCFM 199/312
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The present study was conceived to evaluate the effects of levosimendan on cardiopulmonary exercise test (CPET) and DLCO ( Diffusion capacity of Lung for carbon monoxide) in patients with severe heart failure in stable clinical conditions (NYHA - New York Heart Association - class III, with a peak VO2 (Oxygen consumption ) \< 12 ml/min/kg) on top of optimized standard therapy.

Conditions

Heart Failure

Keywords

Cardiac Failure; Severe Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in Peak VO2 (Oxygen Consumption )

  Primary endpoints: Levosimendan induced changes in peak VO2 (Oxygen consumption )

  48 hours

Secondary Outcomes (2)

• Changes in VE/VCO2

  48 hours

• Change in DLCO (Diffusion Lung CO)

  48 hours

Study Arms (2)

Levosimendan

ACTIVE COMPARATOR

Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.

Drug: Levosimendan

Placebo

PLACEBO COMPARATOR

Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.

Drug: Placebo

Interventions

Levosimendan DRUG

Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min.

Also known as: SIMDAX

Levosimendan

Placebo DRUG

Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min.

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent of the study signed
• severe heart failure in stable clinical condition (NYHA class III, peak VO2 \<12 ml / kg / min) in optimized medical therapy. The clinical stability is defined by the stability of the therapy, the weight and urine output for 3 days

You may not qualify if:

• unstable patients from a clinical point of view, not in optimized therapy
• patients unable to perform a CPET (Cardiopulmonary Exercise Test) .
• are excluded from the protocol also patients with absolute contraindications to CPET (acute myocardial infarction, severe aortic stenosis, myocarditis or pericarditis, active, acute thromboembolism, sepsis,unstable angina, uncontrolled arrhythmia.
• age \< 18 years.

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Orion Corporation, Orion Pharma: collaborator

Study Sites (1)

Centro Cardiologico Monzino

Milan, MI, 20138, Italy

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

Results Point of Contact

• Title: Piergiuseppe Agostoni
• Organization: Centro Cardiologoco Monzino

piergiuseppe.agostoni@ccfm.it

02 5800

Study Officials

• Piergiuseppe Agostoni, MD, PhD

  Centro Cardiologico Monzino,IRCCS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: October 10, 2014
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 6, 2015
• Results First Posted: November 6, 2015

Record last verified: 2015-10

Locations

IT (1)