Phase 4
N=95
SCHEDULE Follow Up Visit 5-7 yr
Heart Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT02864706 ↗Enrolled (actual)
95
Serious AEs
46.3%
Results posted
Oct 2019
Primary outcome: Primary: Measured Glomerular Filtration Rate (mGFR) — 74.7; 62.4 mL/min/1.73m2 — p=0.0043
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Everolimus (Drug); Cyclosporine (Drug); Mycophenolate mofetil (Drug); Corticosteroids (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measured Glomerular Filtration Rate (mGFR) |
74.7; 62.4 | 0.0043 sig |
| SECONDARY Progression of Cardiac Allograft Vasculopathy (CAV) Recorded by Intravascular Ultrasound (IVUS) |
0.13; 0.23 | 0.037 sig |
| SECONDARY Percent of Participants With Incidence of Coronary Allograft Vasculopathy (CAV) |
53; 74 | — |
| SECONDARY Myocardial Structure and Function |
3.1; 3.1; 4.7; 4.9 | — |
| SECONDARY Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up |
16.8; 13.2; 10.4; 15.3; 36.7; 40.8 | — |
| SECONDARY Change From Baseline in the Euro Quality of Life 5D |
0.2323; 0.2982 | — |
| SECONDARY Change From Baseline in Visual Analog Scale (VAS) |
35.6; 34.0 | — |
| SECONDARY Number of Participants With Beck Depression Inventory (BDI) |
15; 13; 6; 4; 2; 5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02864706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.