5, 6 or 7 year follow-up control after receiving a new heart.

5, 6 or 7 year follow-up control after the SCHEDULE study (SCANDINAVIAN HEART TRANSPLANT EVEROLIMUS DE NOVO STUDY WITH EARLY CNI AVOIDANCE) Title of the original SCHEDULE study: A controlled randomized open-label multicentre study evaluating if early initiation of everolimus (Certican®) and early elimination of cyclosporine (Sandimmun Neoral®) in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy. (Protocol: CRAD001ANO02, EudraCT no.: 2009-013074-41) - 5, 6 or 7 year follow-up control after the SCHEDULE study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000404-28-SE

Enrollment

115

Registered

2016-06-02

Start date

2016-07-20

Completion date

Unknown

Last updated

2018-02-05

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

Conditions

Heart transplantation MedDRA version: 19.0 Level: PT Classification code 10019314 Term: Heart transplant System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Certican Product Name: Certican Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed INN: EVEROLIMUS CAS Number: 159351-69-6 Concentration unit: mg milligram(s) Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients who participated in the SCHEDULE 12-month main study, and who completed the 3 year follow-up visit, • Patients who, and are coming for a regularan annual clinic visit 5 or to 7 years after randomization in the main study • Obtaining of a will be asked to participate in this 5 to 7-year follow-up examination. A separate signed patient informed consent will be required for participation in this follow-up examination. 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 85 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Patients with a retransplanted heart since the original SCHEDULE study.

Design outcomes

Primary

Measure	Time frame
Main Objective: The major aim of this extension study was to evaluate the long-term (i.e. 5 to 7 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): Renal function as assessed by measured GFR (mGFR) ;Timepoint(s) of evaluation of this end point: 5-7 years after completion of the main study.	—

Measure

Time frame

Main Objective: The major aim of this extension study was to evaluate the long-term (i.e. 5 to 7 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): Renal function as assessed by measured GFR (mGFR) ;Timepoint(s) of evaluation of this end point: 5-7 years after completion of the main study.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints: • Progression of CAV by IVUS analysis • Myocardial structure and function by echocardiography assessment • 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) ;Timepoint(s) of evaluation of this end point: 5-7 years after completion of the main study.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints: • Progression of CAV by IVUS analysis • Myocardial structure and function by echocardiography assessment • 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) ;Timepoint(s) of evaluation of this end point: 5-7 years after completion of the main study.

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Countries

Denmark, Sweden

Contacts

Public ContactMedical Information

Novartis Sverige AB

medinfo.se@novartis.com+467323200

Outcome results

None listed

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