Status:
UNKNOWN
Long-Term Intermittent Administration of Levosimendan in Patients With Advanced Heart Failure
Lead Sponsor:
Hospital Universitario de Canarias
Conditions:
Advanced Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 co...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT00988806
Start Date
November 1 2009
End Date
December 1 2014
Last Update
September 18 2013
Active Locations (1)
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1
Department of Cardiology. Hospital Universitario de Canarias
San Cristóbal de La Laguna, S.C. de Tenerife, Spain, 38320