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

Primary Purpose

Advanced Heart Failure

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Levosimendan

Placebo

About this trial

This is an interventional treatment trial for Advanced Heart Failure focused on measuring Advanced heart failure, Levosimendan, Intermittent long-term infusions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Department of Cardiology. Hospital Universitario de Canarias

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Levosimendan

Placebo

Arm Description

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

infusion of placebo for 24 hours.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00988806

First Posted

September 29, 2009

Last Updated

September 17, 2013

Sponsor

Hospital Universitario de Canarias

1. Study Identification

Unique Protocol Identification Number

NCT00988806

Brief Title

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

Acronym

LAICA

Official Title

Double-blind Randomized Placebo-controlled Study to Evaluate the Efficacy and Safety of Intermittent, Long-term Administration of Levosimendan in Patients With Advanced Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Unknown status

Study Start Date

November 2009 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Universitario de Canarias

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Aims: To evaluate the efficacy and safety of long-term, intermittent intravenous administration for 24 hours of Levosimendan for the treatment of advanced heart failure. Main end-point: incidence of admission due to decompensation, defined as first admission to emergency services or hospitalization more than 12 hours due to heart failure worsening. Secondary end-points: major cardiac events, serious adverse events, change in NYHA scale at baseline, 30 days, 6 and 12 months; effects on inflammatory and neurohormonal activation in heart failure, identify factors associated with better survival of patients, quality of life, cost-effectiveness of treatment. Study Design: Prospective, randomized, double-blind placebo controlled trial. Scope of the study: patients with advanced heart failure. Study Subjects: Patients over 18 years old with advanced HF of any etiology, with at least one admission for acute decompensation treated or treatable with Levosimendan within 6 months prior to randomization. Interventions: a 24-hour infusion every 30 days of Levosimendan or placebo in addition to optimal pharmacological treatment for HF during 12 months. Determinations: clinical monitoring, protocol-specified analytical determinations, echocardiographic assessment, invasive hemodynamic assessment, functional assessment by 6 min walk test in corridor, quality of life assessment at baseline, after 30 days, 6 months and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Heart Failure

Keywords

Advanced heart failure, Levosimendan, Intermittent long-term infusions

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

213 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Levosimendan

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

infusion of placebo for 24 hours.

Intervention Type

Drug

Intervention Name(s)

Levosimendan

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

one year

Secondary Outcome Measure Information:

Title

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martín J García González, MD, PhD

Organizational Affiliation

Hospital Universitario de Canarias. La Laguna. Tenerife. Spain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Cardiology. Hospital Universitario de Canarias

City

La Laguna

State/Province

S.C. de Tenerife

ZIP/Postal Code

38320

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

23887741

Citation

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.

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

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