ELEVATE Early LEvosimendan Vs Usual Care in Advanced Chronic hearT failurE (ELEVATE)
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ClinicalTrials.gov Identifier: NCT01290146 |
Recruitment Status
:
Terminated
(Due to lack of enrollment)
First Posted
: February 4, 2011
Last Update Posted
: April 10, 2017
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Tracking Information | |||||||
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First Submitted Date ICMJE | February 3, 2011 | ||||||
First Posted Date ICMJE | February 4, 2011 | ||||||
Last Update Posted Date | April 10, 2017 | ||||||
Actual Study Start Date ICMJE | February 2011 | ||||||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Number of days alive free of Transplant and out-of-hospital (DAOH) [ Time Frame: Measured at 12 months ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT01290146 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | ELEVATE Early LEvosimendan Vs Usual Care in Advanced Chronic hearT failurE | ||||||
Official Title ICMJE | Early Use of Levosimendan Compared to Usual Care in Advanced Chronic Heart Failure (ACHF) | ||||||
Brief Summary | The purpose of this study is to compare in patients with Advanced Chronic Heart Failure the effects of Levosimendan versus diuretic (single 24-hour infusion) applied at the early detection of impending destabilization on hospitalization-free survival during 12 months. Patients with advanced chronic heart failure (ACHF) have a short term reduced life expectancy with recurrent hospital admissions for clinical exacerbations. Levosimendan improves contractility by calcium-dependent binding to troponin C, determines vasodilation of the coronary arteries and systemic resistance vessels, thus decreasing preload and afterload, while exerting a protective effect on the myocardium against ischemia-reperfusion damage. In randomized clinical trials of acute heart failure patients, levosimendan improved hemodynamics and patients' quality of life and decreased natriuretic peptide plasma levels, with no excess mortality The study will assess whether the administration of levosimendan (single 24-hour infusion) at the early detection of deterioration may reduce frequency and duration of hospital admissions, improve functional status and quality of life in ACHF patients, with respect to diuretic infusion. |
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Detailed Description | BACKGROUND Patients with advanced chronic heart failure (ACHF) have a short term reduced life expectancy with recurrent hospital admissions for clinical exacerbations. ACHF poses a heavy burden to cardiology departments, where these patients are referred for the severity of their clinical condition, which require a specialist approach, and results in high health care costs due to frequent rehospitalizations. Patients with ACHF ≥ 2 hospital admissions in 6 months are at high risk of recurrent exacerbations. The benefits of strict outpatient follow-up at specialised HF vs standard community care in ACHF patients have been consistently demonstrated. The standard approach at HF clinics is based on flexible diuretic dose and outpatient iv diuretics as bolus or infusion at early signs of decompensation. Although this strategy results in symptomatic benefit and prevents approximately one third of hospital admission for acute exacerbations, a relevant proportion of patients will still need hospitalization. Predictors of lack of benefit are low systolic blood pressure, prior increase in oral diuretics and beta-blocker use, which taken together represent markers of severe disease susceptible to evolve in a low output state. In the HF clinic setting, a novel strategy for these patients, to include early support to myocardial contractility, i.e. before compelling criteria for hospital admission become manifest, might prevent further prolonged hospitalizations, myocardial damage and impairment in renal function TRIAL RATIONALE Levosimendan improved hemodynamics and patients' quality of life and decreased natriuretic peptide plasma levels, with no excess mortality, in randomized clinical trials of acute heart failure. In SURVIVE an early larger treatment effect of levosimendan was apparent in patients with acute worsening of chronic HF treatment than in those with de novo disease, possibly because a greater proportion of these patients may be on beta-blockers, that are known to interfere with dobutamine or may potentiate the circulatory actions of levosimendan. Thus levosimendan may be unattractive first-line agent in destabilized ACHF patients on beta-blockers. Based on the drug cardioprotective properties, hemodynamic and neurohormonal effects, we propose a novel therapeutic approach for the clinically-driven use of levosimendan in recurrent acute exacerbations of ACHF. Dosing of the drug will omit the bolus to increase tolerability in this severely ill patient population. |
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Chronic Heart Failure | ||||||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE |
13 | ||||||
Original Estimated Enrollment ICMJE |
134 | ||||||
Actual Study Completion Date | March 2017 | ||||||
Actual Primary Completion Date | June 2015 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Italy | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01290146 | ||||||
Other Study ID Numbers ICMJE | EudraCT code 2009-016958-41 FO002 ( Registry Identifier: Ethics Committee ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Niguarda Hospital | ||||||
Study Sponsor ICMJE | Niguarda Hospital | ||||||
Collaborators ICMJE | Orion Corporation, Orion Pharma | ||||||
Investigators ICMJE |
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PRS Account | Niguarda Hospital | ||||||
Verification Date | April 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |