Long-term follow-up of the patients enrolled in the SCHEDULE trial, in which we randomly allocated heart transplant recipients to standard treatment with the immunosuppressant ciclosporine or the newer imunosuppressant everolimus.

10 to 12 year extended follow-up of the SCHEDULE study (SCANDINAVIAN HEART TRANSPLANT EVEROLIMUS DE NOVO STUDY WITH EARLY CNI AVOIDANCE) - SCHEDULE 10 years

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004831-21-NO

Enrollment

120

Registered

2019-12-10

Start date

2020-01-09

Completion date

Unknown

Last updated

2025-03-31

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

Conditions

Herat transplant MedDRA version: 21.1 Level: LLT Classification code 10050432 Term: Prophylaxis against heart transplant rejection System Organ Class: 100000004865

Interventions

Trade Name: Certican Product Name: EVEROLIMUS Product Code: RAD001 Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who 1)participated in the SCHEDULE 12-month main study, and who 2) are coming for a regular annual clinic visit 10 to 12 years after randomization in the main study 3) are willing to provide a separate signed patient informed consent for this follow-up study 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Patients with a cardiac retransplant since the original SCHEDULE study

Design outcomes

Primary

Measure	Time frame
Main Objective: The major aim of this extension study is to evaluate the long-term (i.e. 10 - 12 years) effect of early initiation of everolimus and early elimination of CsA compared to standard immunosuppressive regimen including CsA on primary and secondary endpoints investigated in the SCHEDULE main study (Protocol: CRAD001ANO02, EudraCT no.: 2009-013074-41). ;Secondary Objective: Quality of life will be examined using three validated questionnaires, i.e. the SF-36, EQ 5D, and the BDI form.;Primary end point(s): The primary endpoint is the estimated glomerular filtration rate ;Timepoint(s) of evaluation of this end point: 10-12 years after randomisation in the SCHEDULE trial	—

Measure

Time frame

Main Objective: The major aim of this extension study is to evaluate the long-term (i.e. 10 - 12 years) effect of early initiation of everolimus and early elimination of CsA compared to standard immunosuppressive regimen including CsA on primary and secondary endpoints investigated in the SCHEDULE main study (Protocol: CRAD001ANO02, EudraCT no.: 2009-013074-41). ;Secondary Objective: Quality of life will be examined using three validated questionnaires, i.e. the SF-36, EQ 5D, and the BDI form.;Primary end point(s): The primary endpoint is the estimated glomerular filtration rate ;Timepoint(s) of evaluation of this end point: 10-12 years after randomisation in the SCHEDULE trial

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Secondary

Measure	Time frame
Secondary end point(s): • Degree of of CAV evaluated by coronary angiography • Myocardial structure and function by echocardiography assessment • Exercise capacity evaluated by Cardiopulmonary Exercise Testing • Quality of life by SF-36 (Minnesota Living with Heart Failure Questionnaire), Euro Quality of Life 5D (EQ 5D), and Beck Depression Inventory (BDI) form • Number of adverse events (AEs)/serious adverse events (SAEs) • Presence of donor specific antibodies (DSA) ;Timepoint(s) of evaluation of this end point: 10-12 years after randomisation in the SCHEDULE trial	—

Measure

Time frame

Secondary end point(s): • Degree of of CAV evaluated by coronary angiography • Myocardial structure and function by echocardiography assessment • Exercise capacity evaluated by Cardiopulmonary Exercise Testing • Quality of life by SF-36 (Minnesota Living with Heart Failure Questionnaire), Euro Quality of Life 5D (EQ 5D), and Beck Depression Inventory (BDI) form • Number of adverse events (AEs)/serious adverse events (SAEs) • Presence of donor specific antibodies (DSA) ;Timepoint(s) of evaluation of this end point: 10-12 years after randomisation in the SCHEDULE trial

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Countries

Norway

Contacts

Public ContactArne K Andreassen

Oslo University Hospital

aandreas@ous-hf.no004723070000

Outcome results

None listed

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