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

Phase 1

Conditions: Heart transplantation
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
MedDRA version: 19.0Level: PTClassification code 10019314Term: Heart transplantSystem Organ Class: 10042613 - Surgical and medical procedures

Registration Number: EUCTR2016-000404-28-SE

Lead Sponsor: ovartis Norge AS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 115

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

Patients with a retransplanted heart since the original SCHEDULE study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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). <br>;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)<br>;Timepoint(s) of evaluation of this end point: 5-7 years after completion of the main study.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints:<br>• Progression of CAV by IVUS analysis<br>• Myocardial structure and function by echocardiography assessment<br>• 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<br>• Number of adverse events (AEs)/serious adverse events (SAEs)<br>;Timepoint(s) of evaluation of this end point: 5-7 years after completion of the main study.