Clinical trial NCT02864706: SCHEDULE Follow Up Visit 5-7 yr
Official title: 5, 6 or 7 Year Follow-up Control After the SCHEDULE Study (SCANDINAVIAN HEART TRANSPLANT EVEROLIMUS DE NOVO STUDY WITH EARLY CNI AVOIDANCE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Transplantation
Keywords: allograft rejection
xenograft rejection
host vs graft disease
transplant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-08-12
Enrollment: 95
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The major aim of this extension study was to evaluate the long-term effect (i.e. 5 to 7 years) 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 (NCT01266148) main study.

Detailed description: This protocol was written to describe the procedures for a single 5, 6 or 7 year follow-up control visit of patients who participated in the 12-month SCHEDULE (NCT01266148) study and the following 3-year follow-up examination/visit. The aim of this 5 to 7-year follow-up visit was to examine the effect of long term treatment, i.e. 5, 6 or 7 years, with early initiation of everolimus (Certican®) and early elimination of cyclosporine (CsA), compared to standard immunosuppressive regimen including CsA, on renal and heart function. During the time period of this follow-up examinations, this visit was performed as part of a routine annual visit 5, 6 or 7 years since transplantation (and inclusion in the original SCHEDULE study).

Study code of SCHEDULE, the core study: CRAD001ANO02 (EudraCT No.: 2009-013074-41)

Eligibility criteria: Inclusion Criteria:

* Patients who participated in the SCHEDULE 12-month main study, and who completed the 3 year follow-up visit
* Patients who are coming for a regular annual clinic visit 5 to 7 years after randomization in the main study
* Obtaining of a separate signed patient informed consent will be required for participation in this follow-up examination.

Exclusion Criteria:

* Patients with a retransplanted heart since the original SCHEDULE study

Primary outcomes:
measure: Measured Glomerular Filtration Rate (mGFR)
timeFrame: at the 5-7 year follow-up visit
Secondary outcomes:
measure: Progression of Cardiac Allograft Vasculopathy (CAV) Recorded by Intravascular Ultrasound (IVUS)
timeFrame: within 5-7 years
measure: Percent of Participants With Incidence of Coronary Allograft Vasculopathy (CAV)
timeFrame: at the 5-7 year follow-up
measure: Myocardial Structure and Function
timeFrame: within 5-7 years
measure: Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up
timeFrame: at the 5-7 year visit
measure: Change From Baseline in the Euro Quality of Life 5D
timeFrame: Baseline, 5-7 year visit
measure: Change From Baseline in Visual Analog Scale (VAS)
timeFrame: baseline, at the 5-7 year visit
measure: Number of Participants With Beck Depression Inventory (BDI)
timeFrame: at the 5-7 year visit
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Århus N
country: Denmark
facility: Novartis Investigative Site
city: Oslo
country: Norway
facility: Novartis Investigative Site
city: Göteborg
country: Sweden
facility: Novartis Investigative Site
city: Linkoping
country: Sweden
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Andreassen AK, Andersson B, Gustafsson F, Eiskjaer H, Radegran G, Gude E, Jansson K, Solbu D, Karason K, Arora S, Dellgren G, Gullestad L; SCHEDULE investigators. Everolimus Initiation With Early Calcineurin Inhibitor Withdrawal in De Novo Heart Transplant Recipients: Three-Year Results From the Randomized SCHEDULE Study. Am J Transplant. 2016 Apr;16(4):1238-47. doi: 10.1111/ajt.13588. Epub 2016 Jan 28.