Early LEvosimendan Vs usual care in Advanced chronic hearT failurE - ELEVATE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016958-41-IT

Enrollment

134

Registered

2010-01-21

Start date

2010-02-28

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced chronic heart failure MedDRA version: 9.1 Level: SOC Classification code 10007541 MedDRA version: 9.1 Level: SOC Classification code 10007541

Interventions

Trade Name: SIMDAX Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Levosimendan Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 18-80 years - clinical stability - Written informed consent - Systolic dysfunction (LVEF ≤ 35% by echo assessment within 6 months before enrolment) - No requirement for hospital admission for diagnostic work up or elective treatment to define etiology and/or treatment plan - Already on optimal standard HF treatment based on individual tolerance, including cardiac resynchronization therapy (CRT)/ICD device according to current guidelines - At least 2 hospital admissions for HF in the 6 months before enrolment, the most recent one within 30-90 days before enrolment with requirement for inotrope administration Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Acute coronary syndromes, percutaneous or surgical revascularization, valve surgery performed within 8 weeks before enrolment - Planned percutaneous or surgical procedures (except for heart transplantation) - CRT within 6 months before enrolment - Cardiogenic shock - Supine systolic BP three-fold increase in AST-ALT ) - Sever chronic kidney dysfunction (estimated GFR 38 C, WBC >15,000/mm3) - Severe chronic obstructive pulmonary disease (FEV1 <30% predicted or on oxygen therapy) - Severe persistent anemia (Hb < 10 g/l)) - ACHF exacerbation due to conditions requiring specific treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess comparatively the effects of 24-hour continuous infusion of levosimendan or diuretics at early signs of clinical destabilization on hospital admissions and emergency room visits during 12 months;Secondary Objective: To assess comparatively the effects of 24-hour continuous infusion of levosimendan or diuretics at early signs of clinical destabilization on functional status, quality of life, neurohormones, renal function;Primary end point(s): Number of days alive free of Transplant and out-of-hospital (DAOH) at 12 months	—

Measure

Time frame

Main Objective: To assess comparatively the effects of 24-hour continuous infusion of levosimendan or diuretics at early signs of clinical destabilization on hospital admissions and emergency room visits during 12 months;Secondary Objective: To assess comparatively the effects of 24-hour continuous infusion of levosimendan or diuretics at early signs of clinical destabilization on functional status, quality of life, neurohormones, renal function;Primary end point(s): Number of days alive free of Transplant and out-of-hospital (DAOH) at 12 months

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026