NCT03022877

Brief Summary

In the proposed project the investigators want to assess whether the approach of the post-conditioning by Levosimendan in patients with acute STEMI is safe and reproducible, can be used with a positive influence on the outcomes with respect to myocardial damage, cardiac left ventricular remodeling, myocardial function, the occurrence of cardiac events and quality of life.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2017

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

1.5 years

First QC Date

January 6, 2017

Last Update Submit

October 25, 2022

Conditions

Myocardial InfarctionOutcome

Outcome Measures

Primary Outcomes (1)

  • Reduction of the increase in left ventricular end-diastolic volume index (LVEDVi)

    echocardiography and MRI examinations (LVEDVi) and comparison between baseline and 12 months data

    12 months after coronary intervention due to the infarction

Secondary Outcomes (5)

  • Size of the acute myocardial damage due to the infarction

    12 months after coronary intervention due to the infarction

  • Event-free survival

    12 months after coronary intervention due to the infarction

  • functional changes (imaging)

    12 months after coronary intervention due to the infarction

  • structural changes

    12 months after coronary intervention due to the infarction

  • functional changes (spirometry)

    12 months after coronary intervention due to the infarction

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo is given as a Bolus (instead of Bolus application of Levosimendan) over 10 min i.v., starting 10 min before recanalization.

Drug: Levosimendan

Bolus Levosimendan

ACTIVE COMPARATOR

Levosimendan is given as Bolus (12 µg/kg over 10 min i.v.), starting 10 min before recanalization.

Drug: Levosimendan

Bolus and infusion Levosimendan

ACTIVE COMPARATOR

Levosimendan is given as Bolus (12 µg/kg over 10 min i.v.), starting 10 min before recanalization and additionally as continuous infusion (0.1-0.2 µg/kg/min i. v. for 24 hours).

Drug: Levosimendan

Interventions

LevosimendanDRUG

In a prospective randomized setting, patients are included with an acute STEMI of the anterior wall. A bolus administration Levosimendan with/without following continuous infusion over 24 hours compared to a control group (placebo) will be examined. The initiation of therapy is carried out for 10 min. prior to reperfusion. The coronary Intervention is performed immediately after inclusion at the latest within 6 hours after the onset of symptoms. The administration of Levosimendan is based on a fixed schema: Bolus: 12 µg/kg over 10 min I. V., starting 10 min before recanalization and an addition of 0.1-0.2 µg/kg/min i. v. for 24 hours in the continuous infusion group.

Bolus LevosimendanBolus and infusion LevosimendanPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • STEMI of the anterior wall \< 6 hrs
  • capacity to Consent

You may not qualify if:

  • previous myocardial infarction or bypass surgery
  • relevant vitium
  • STEMI of the posterior wall
  • any contraindications to MRI
  • unstable hemodynamics (hypotension, catecholamine therapy, severe arrhythmia), -respiratory failure
  • onset of symptoms more than 6 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Brooks GC, Lee BK, Rao R, Lin F, Morin DP, Zweibel SL, Buxton AE, Pletcher MJ, Vittinghoff E, Olgin JE; PREDICTS Investigators. Predicting Persistent Left Ventricular Dysfunction Following Myocardial Infarction: The PREDICTS Study. J Am Coll Cardiol. 2016 Mar 15;67(10):1186-1196. doi: 10.1016/j.jacc.2015.12.042.

    PMID: 26965540BACKGROUND

  • Kloner RA, Jennings RB. Consequences of brief ischemia: stunning, preconditioning, and their clinical implications: part 2. Circulation. 2001 Dec 18;104(25):3158-67. doi: 10.1161/hc5001.100039.

    PMID: 11748117RESULT

  • Yellon DM, Hausenloy DJ. Myocardial reperfusion injury. N Engl J Med. 2007 Sep 13;357(11):1121-35. doi: 10.1056/NEJMra071667. No abstract available.

    PMID: 17855673RESULT

  • du Toit EF, Smith W, Muller C, Strijdom H, Stouthammer B, Woodiwiss AJ, Norton GR, Lochner A. Myocardial susceptibility to ischemic-reperfusion injury in a prediabetic model of dietary-induced obesity. Am J Physiol Heart Circ Physiol. 2008 May;294(5):H2336-43. doi: 10.1152/ajpheart.00481.2007. Epub 2008 Mar 21.

    PMID: 18359896RESULT

  • Hein M, Roehl AB, Baumert JH, Scherer K, Steendijk P, Rossaint R. Anti-ischemic effects of inotropic agents in experimental right ventricular infarction. Acta Anaesthesiol Scand. 2009 Aug;53(7):941-8. doi: 10.1111/j.1399-6576.2009.01994.x. Epub 2009 May 6.

    PMID: 19426242RESULT

  • Kin H, Zhao ZQ, Sun HY, Wang NP, Corvera JS, Halkos ME, Kerendi F, Guyton RA, Vinten-Johansen J. Postconditioning attenuates myocardial ischemia-reperfusion injury by inhibiting events in the early minutes of reperfusion. Cardiovasc Res. 2004 Apr 1;62(1):74-85. doi: 10.1016/j.cardiores.2004.01.006.

    PMID: 15023554RESULT

  • Qarawani D, Cohen A, Nahir M, Hasin Y. Facilitation of left ventricular function recovery post percutaneous coronary intervention by levosimendan. Int J Cardiol. 2013 Sep 20;168(1):237-42. doi: 10.1016/j.ijcard.2012.09.088. Epub 2012 Oct 11.

    PMID: 23063476RESULT

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Simendan

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Michael Becker

    Cardiology, RWTH University Hospital Aachen

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 18, 2017

Study Start

June 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share