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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00988806 |
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Date of registration:
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29/09/2009 |
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Primary sponsor: |
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Public title:
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Long-Term Intermittent Administration of Levosimendan in Patients With Advanced Heart Failure
LAICA |
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Scientific title:
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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 |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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213 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT00988806 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Spain
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Contacts
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Name:
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Martín J García González, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Universitario de Canarias. La Laguna. Tenerife. Spain |
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Key inclusion & exclusion criteria
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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
- 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Advanced Heart Failure
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Intervention(s)
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Drug: Levosimendan
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Drug: Placebo
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Primary Outcome(s)
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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.
[Time Frame: one year]
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Secondary Outcome(s)
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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.
[Time Frame: one year]
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Secondary ID(s)
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EudraCT 2009-011441-11
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LAICA Study 2009
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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