NCT01160978

Brief Summary

The aim of the study is to investigate the effects of donor simvastatin treatment on ischemia-reperfusion injury after heart transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for phase_2 heart-failure

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_2 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2010

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

6.2 years

First QC Date

July 12, 2010

Last Update Submit

September 17, 2017

Conditions

Heart FailureRespiratory FailureLiver FailureKidney FailureTransplantation

Keywords

TransplantationSimvastatin treatmentIschemia-reperfusion injuryRejection

Outcome Measures

Primary Outcomes (1)

  • Donor treatment with simvastatin reduces ischemia-reperfusion injury after heart transplantation

    Recipient plasma release of cardiac troponins and creatinine kinase-MB and P-lactate, S-hs-CRP, peripheral blood leukocytes and neutrophils after heart transplantation

    1-24 hour

Secondary Outcomes (14)

  • Postoperative hemodynamics

    0-72h

  • Postoperative use of inotropes and hemodynamic support

    0-72h

  • Heart transplant function

    0-20 years

  • Cardiac allograft vasculopathy

    at 1, 3, and 5 years

  • Biopsy proven acute rejection

    0-20 years

  • +9 more secondary outcomes

Study Arms (2)

Simvastatin 80 mg group

ACTIVE COMPARATOR

The transplant recipients who have received an organ from donors treated with simvastatin 80 mg.

Drug: Simvastatin 80mg

Control Rx

EXPERIMENTAL

The transplant recipients who have received an organ from non-treated donors.

Drug: Control Rx

Interventions

Simvastatin 80mgDRUG

The transplant recipients who have received an organ from donors treated with simvastatin 80 mg.

Also known as: simvastatin
Simvastatin 80 mg group
Control RxDRUG

The transplant recipients who have received an organ from non-treated donors.

Control Rx

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heart transplant donor
  • Age 18-60 years
  • Previously healthy
  • No cholesterol medication
  • Normal ECHO with LVEF \>45%, normal right ventricle and normal coronary angiography
  • PiO2/FiO2 \> 40kPA, normal chest radiograph and normal bronchoscopy in lung donors

You may not qualify if:

  • Severe left ventricular hypertrophy \> 14 mm
  • High dose of inotropes (dopamine or dobutamine \> 20ug/kg/min or norepinephrine \>0.2 ug/kg/min) at the time of procurement
  • Donor outside of the study country Finland
  • Age between 18-70 for heart transplant recipients
  • Male or female
  • Listed for heart, lung, kidney, or liver transplantation
  • Exclusive Criteria for the recipient
  • systemic sepsis
  • a positive cross match

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Surgery, Heart and Lung Center, Helsinki University Hospital

Helsinki, FI-00029, Finland

Location

Related Publications (1)

  • Nykanen AI, Holmstrom EJ, Tuuminen R, Krebs R, Dhaygude K, Kankainen M, Jokinen JJ, Lommi J, Helantera I, Raisanen-Sokolowski A, Syrjala SO, Lemstrom KB. Donor Simvastatin Treatment in Heart Transplantation. Circulation. 2019 Aug 20;140(8):627-640. doi: 10.1161/CIRCULATIONAHA.119.039932. Epub 2019 Jul 29.

    PMID: 31352795DERIVED

Related Links

MeSH Terms

Conditions

Heart FailureRespiratory InsufficiencyLiver FailureRenal InsufficiencyReperfusion InjuryRejection, Psychology

Interventions

SimvastatinTin Fluorides

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesHepatic InsufficiencyLiver DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesVascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsFluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsTin CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Karl B Lemstrom, MD, PhD

    Cardiac surgery, Heart and Lung Center, Helsinki University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiothoracic Surgeon

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 13, 2010

Study Start

June 1, 2010

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 19, 2017

Record last verified: 2017-09

Locations

FI(1)