NCT03991923

Brief Summary

The study intends to compare standard ischemic cold static storage (ICSS) of retrieved hearts intended to be transplanted, to non-ischemic heart preservation (NIHP) in a randomized clinical multicentre trial. The primary hypothesis is that the non-ischemic hypothermic cardioplegic preservation (NIHP) is safe and superior to ischemic cold static storage (ICSS) of donor hearts. The study will investigate the safety and superiority of the new methodology in terms of improved immediate and prolonged organ function in adult heart transplanted patients.

Trial Health

82
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
8 countries

15 active sites

Status
active not recruiting

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 Progress67%
Nov 2020Dec 2028

First Submitted

Initial submission to the registry

June 4, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 25, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

June 4, 2019

Last Update Submit

April 16, 2026

Conditions

Heart Transplantation

Keywords

Non Ischemic Heart Preservation (NIHP)Ischemic cold static storage of donor hearts (ICSS)

Outcome Measures

Primary Outcomes (1)

  • 30 days mortality and 30 days graft dysfunction

    The Primary End-Point is defined as time-to-first-event of cardiac related death, moderate or severe primary graft dysfunction of the left ventricle or primary graft dysfunction of the right ventricle (according to Kobashigawa et al., 2014), acute cellular rejection ≥2R (according to Stewart et al., 2005) or graft failure (use of mechanical circulatory support or retransplantation) within 30 days.

    30 days

Secondary Outcomes (23)

  • 1 year mortality and 1 year graft dysfunction

    1 year

  • 30 days and 1 year mortality and graft dysfunction

    30 days and 1 year

  • CKMB

    3 days

  • TnI

    3 days

  • ProBNP

    3 days

  • +18 more secondary outcomes

Other Outcomes (19)

  • Serious adverse device effects

    1 year

  • Adverse device effects

    1 year

  • Device dysfunction resulting in loss of transplantable heart

    12 hours

  • +16 more other outcomes

Study Arms (2)

Non-ischemic heart preservation (NIHP)

EXPERIMENTAL

Continous cold cardioplegic perfusion of hearts

Device: XVIVO heart preservation devices

Ischemic cold static storage (ICSS)

ACTIVE COMPARATOR

Standard preservation technique

Device: Standard ICSS

Interventions

XVIVO heart preservation devicesDEVICE

The intervention is to preserve hearts during transportation cold, cardioplegic and non-ischemic, with a high oncotic and hormone supplemented perfusate.

Non-ischemic heart preservation (NIHP)
Standard ICSSDEVICE

Cold static preservation using standard preservation solution

Ischemic cold static storage (ICSS)

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • Signed informed consent form
  • Listed for heart transplantation
  • Age ≥18 and ≤70 years
  • Accepted as heart donor by the transplant team
  • (Research consent from the donor if required in country)

You may not qualify if:

  • Previous solid organ transplantation
  • Grown-up congenital heart disease (GUCH)
  • Kidney failure eGFR\<40 at listing, calculated by CDK-EPI Creatinine, or ultrafiltration or dialysis or rapidly deteriorating kidney function due to a diagnosed renal disease
  • Coagulopathy due to known hepatic disease or heparin induced thrombocytopenia
  • Subject diagnosed with Systemic Lupus Erythematous, sarcoidosis or amyloidosis
  • Known ongoing septicemia defined as positive blood culture immediately prior to the transplant (including with a durable VAD)
  • Incompatible blood group
  • Not able to understand the information provided during the informed consent procedure
  • Combined organ transplantation candidates
  • Subject already enrolled in another transplant related intervention study
  • Subjects under pre-transplant desensitization protocol (including plasma exchange in conjunction with the transplant surgery)
  • Mechanical circulatory support pre-transplantation (except durable Left ventricular assist device or Intra-aortic balloon pump)
  • Previous sternotomy
  • DCD hearts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Allgemeines Krankenhaus der Stadt Wien

Vienna, Austria

Location

UZ Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Institut de cardiologie, Chirurgie thoracique et cardiovasculaire La Pitié Salpetrière

Paris, Paris Cedex, 75651, France

Location

Hôpital Bichat Claude-Bernard

Paris, France

Location

Klinikum der Universität München

München, Bavaria, 81377, Germany

Location

Deutschen Herzzentrum Berlin

Berlin, Brandenburg, 13353, Germany

Location

Universitätsklinik der Ruhr-Universität Bochum

Bad Oeynhausen, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Hannover Medical School

Hanover, Germany

Location

Azienda osedalaria di Padova

Padova, Padova PD, 35121, Italy

Location

Hospital Puerto de Hierro

Madrid, Majadahonda Madrid, 28222, Spain

Location

Sahlgrenska University Hospital

Gothenburg, Västra Götalands Regionen, 412 34, Sweden

Location

Freeman Hospital

Newcastle, Newcastle Upon Tyne, NE77DN, United Kingdom

Location

Queen Elisabeth Hospital

Birmingham, B152TH, United Kingdom

Location

Royal Papworth Hospital

Cambridge, United Kingdom

Location

Related Publications (2)

  • Rega F, Lebreton G, Para M, Michel S, Schramm R, Begot E, Vandendriessche K, Kamla C, Gerosa G, Berman M, Boeken U, Clark S, Ranasinghe A, Ius F, Forteza A, Pivodic A, Hennig F, Guenther S, Zuckermann A, Knosalla C, Dellgren G, Wallinder A; NIHP2019 investigators. Hypothermic oxygenated perfusion of the donor heart in heart transplantation: the short-term outcome from a randomised, controlled, open-label, multicentre clinical trial. Lancet. 2024 Aug 17;404(10453):670-682. doi: 10.1016/S0140-6736(24)01078-X.

    PMID: 39153817DERIVED

  • Brouckaert J, Dellgren G, Wallinder A, Rega F. Non-ischaemic preservation of the donor heart in heart transplantation: protocol design and rationale for a randomised, controlled, multicentre clinical trial across eight European countries. BMJ Open. 2023 Dec 28;13(12):e073729. doi: 10.1136/bmjopen-2023-073729.

    PMID: 38154894DERIVED

Study Officials

  • Filip Rega, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 19, 2019

Study Start

November 25, 2020

Primary Completion

August 31, 2023

Study Completion (Estimated)

December 31, 2028

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)IT(1)FR(2)BE(1)GB(3)AU(1)ES(1)DE(5)