Long-Term Intermittent Administration of Levosimendan in Patients With Advanced Heart Failure

NCT00988806 | Unknown Phase 4

• 2 other identifiers: LAICA Study 2009EudraCT 2009-011441-11
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the treatment strategy of long-term intermittent every 30 days, continuous intravenous infusion for 24 hours of Levosimendan, associated to optimal contemporary treatment for advanced heart failure reduce the incidence of admission for heart failure worsening at 12 months follow up, compared with the strategy based solely in the optimal contemporary treatment for advanced heart failure.

Conditions

Advanced Heart Failure

Keywords

Advanced heart failure; Levosimendan; Intermittent long-term infusions

Outcome Measures

Primary Outcomes (1)

• Evaluate the incidence of admission for heart failure worsening in patients with advanced heart failure, defined as first admission to emergency services or hospitalization more than 12 hours due to a heart failure worsening.

  one year

Secondary Outcomes (1)

• Time from randomization until first hospitalization for heart failure worsening. All-cause mortality. Major cardiac events. Serious adverse events. Changes in NYHA scale and quality of life of patients. To analyze the cost-effectiveness of treatment.

  one year

Study Arms (2)

Levosimendan

ACTIVE COMPARATOR

infusion of levosimendan at doses of 0.1 mcg / kg / min for 24 hours.

Drug: Levosimendan

Placebo

PLACEBO COMPARATOR

infusion of placebo for 24 hours.

Drug: Levosimendan; Drug: Placebo

Interventions

Levosimendan DRUG

Patients included in the intervention group receive optimal drug therapy for heart failure symptoms and also infusion of levosimendan at doses of 0.1 mcg / kg / min for 24 hours every 30 days. Failure to reach an appropriate level of heart failure compensation before the deadline of 30 days for the next study drug administration or placebo, the administration of them will be every 15 days. Thereafter, failure to reach an appropriate level of heart failure compensation for patients or worsen after two consecutive infusions of study drug or placebo every 15 days, proceed to open the code patient randomization and and apply the most appropriate treatment.

Levosimendan; Placebo

Placebo DRUG

Patients included in the placebo group receive optimal drug therapy for heart failure and also infusion of placebo at the same infusion rate as levosimendan doses of 0.1 mcg / kg / min for 24 hours every 30 days. Failure to reach an appropriate level of heart failure compensation before the deadline of 30 days for the next study drug administration or placebo, the administration of them will be every 15 days. Thereafter, failure to reach an appropriate level of heart failure compensation for patients or worsen after two consecutive infusions of study drug or placebo every 15 days, proceed to open the code patient randomization and and apply the most appropriate treatment.

Placebo

Eligibility Criteria

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

You may qualify if:

• Age over 18
• Severe symptoms of heart failure with dyspnea and/or fatigue at rest or minimal effort (functional class III and IV of NYHA)
• Episodes of fluid retention (pulmonary or systemic venous congestion, peripheral edema) and/or low cardiac output at rest (peripheral hypoperfusion)
• objective evidence of severe cardiac dysfunction determined by the presence of at least one of the following:
• Left ventricular ejection fraction \</= 30%
• A severe impairment of cardiac function by echocardiography with Doppler transmitral flow pattern pseudonormal or restrictive.
• A left ventricular filling pressure elevated (PCP\> 16 mmHg and / or DBP average\> 12 mm Hg for pulmonary artery catheterization)
• Levels of BNP or NT-proBNP higher in the absence of noncardiac causes for this.
• Severe impairment of functional capacity as evidenced by one of the following:
• Inability to exercise
• A distance \<300 m or less in women and / or patients \>/= 75 years in the 6-minute walk test
• A test of myocardial oxygen consumption \<12-14 ml / kg / min.
• \>/= 1 prior history of HF hospitalization in the previous 6 months
• Presence of all the above criteria despite attempts to optimize therapy including diuretics, inhibitors of the renin-angiotensin-aldosterone system and beta-blockers, unless these drugs were not tolerated or were contraindicated, and cardiac resynchronization therapy when indicated.
• consent to participate in the study.

You may not qualify if:

• Levosimendan allergy or hypersensitivity.
• Severe renal impairment (creatinine clearance \<30 ml / min).
• Severe liver impairment.
• History of autoimmune disease.
• Pregnancy.
• Women of childbearing age not using adequate contraception (hormonal, IUD, barrier + spermicide)
• Heart disease with significant obstructions to ventricular filling or emptying.
• Severe hypotension (Systolic \< 90 mmHg).
• Tachycardia \> 120 bpm or a history of torsion point type ventricular tachycardia.
• Severe concomitant disease with decreased short-term prognosis.
• Inability to give informed consent.
• Participation in another study.

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead

Study Sites (1)

Department of Cardiology. Hospital Universitario de Canarias

San Cristóbal de La Laguna, S.C. de Tenerife, 38320, Spain

Location

Related Publications (1)

• Garcia-Gonzalez MJ, de Mora-Martin M, Lopez-Fernandez S, Lopez-Diaz J, Martinez-Selles M, Romero-Garcia J, Cordero M, Lara-Padron A, Marrero-Rodriguez F, del Mar Garcia-Saiz M, Aldea-Perona A; LAICA study investigators. Rationale and design of a randomized, double-blind, placebo controlled multicenter trial to study efficacy, security, and long term effects of intermittent repeated levosimendan administration in patients with advanced heart failure: LAICA study. Cardiovasc Drugs Ther. 2013 Dec;27(6):573-9. doi: 10.1007/s10557-013-6476-7.

  PMID: 23887741 BACKGROUND

MeSH Terms

Interventions

Simendan

Intervention Hierarchy (Ancestors)

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

Study Officials

• Martín J García González, MD, PhD

  Hospital Universitario de Canarias. La Laguna. Tenerife. Spain

  PRINCIPAL INVESTIGATOR

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: Consultant MD, PhD

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: October 2, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: September 18, 2013

Record last verified: 2013-09

Locations

ES (1)