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Completed

NCT Number: NCT02864706

SCHEDULE Follow Up Visit 5-7 yr

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.

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Key information

Conditions

Heart Transplantation Graft vs Host Disease Immune System Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Copenhagen, Denmark

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus

Drug

All patients, independent of their initial randomization in the core study, were followed up as in one single group

Commercially available everolimus (Certican®), oral route, was used.

cyclosporine

Drug

Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3)

Mycophenolate mofetil

Drug

Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11

Corticosteroids

Drug

Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups.

Primary outcomes

  1. Measured Glomerular Filtration Rate (mGFR)

    Time frame: at the 5-7 year follow-up visit

    Renal function as assessed by measured Glomerular Filtration Rate (mGFR) (Cr-EDTA or iohexol clearance). Baseline Visit 1 and Patient 4252 excluded from the intent treat analysis set.

Secondary outcomes

  1. Progression of Cardiac Allograft Vasculopathy (CAV) Recorded by Intravascular Ultrasound (IVUS)

    Time frame: within 5-7 years

    Cardiac Allograft Vasculopathy (CAV) was defined as mean maximal intimal thickness (MIT)

    ≥0.5 mm, measured for the entire matched pullback recording by intravascular ultrasound (IVUS). The incidence of CAV at 5-7 years was compared between groups using the Cochran-Mantel-Haenszel test with stratification according to baseline distribution of CAV incidence.

  2. Percent of Participants With Incidence of Coronary Allograft Vasculopathy (CAV)

    Time frame: at the 5-7 year follow-up

    Cardiac Allograft Vasculopathy (CAV) was defined as mean maximal intimal thickness (MIT)

    ≥0.5 mm, measured for the entire matched pullback recording by intravascular ultrasound (IVUS). The incidence of CAV at 5-7 years was compared between groups using the Cochran-Mantel-Haenszel test with stratification according to baseline distribution of CAV incidence.

  3. Myocardial Structure and Function

    Time frame: within 5-7 years

    Myocardial structure and function by echocardiography assessment measured by ventricular end systolic diameter.

  4. Quality of Life by SF-36 Change From Pre-transplantation to 5-7 Year Follow-up

    Time frame: at the 5-7 year visit

    This Quality of life Short Form Survey with 36 items (Minnesota Living with Heart Failure Questionnaire)was administered to patients pre-transplantation and after transplantation at the 5-7 year visit. This data represents the change. The survey consist of scores on a scale. Each form is scaled from 0 t 100. 0 = maximum disability and 100 equals no disability.

  5. Change From Baseline in the Euro Quality of Life 5D

    Time frame: Baseline, 5-7 year visit

    Change from baseline in Euro Quality of Life-5D from 3 Year Follow-Up to 5 to 7 Year Follow-Up Baseline Visit 1 (ITT Set)

    Euro Quality of Life 5D (EQ-5D): is a descriptive system of healthrelated quality of life states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) each of which can be assessed as one of three levels of severity (no problems/some or moderate problems/extreme problems). A Visual Analogue Scale (VAS)-scale is also included in the EQ-5D questionnaire.

    The EQ-5D index is calculated based on the United Kingdom Time Trade-Off (TTO) N3 value set which converts the five dimensions scores into a single measure with a possible range from -0.163 (worst possible health state) to +1 (perfect health). A positive change from baseline indicates an improvement in Quality of Life.

  6. Change From Baseline in Visual Analog Scale (VAS)

    Time frame: baseline, at the 5-7 year visit

    Change in visual analog scale (VAS) from baseline to the 5 to 7 Year follow up visit.

    0 is no pain; and 10 is the worst possible pain

  7. Number of Participants With Beck Depression Inventory (BDI)

    Time frame: at the 5-7 year visit

    Beck Depression Inventory (BDI) Score has the following categories of depression. Normal, Mild, Moderate Severe and Missing.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

5, 6 or 7 Year Follow-up Control After the SCHEDULE Study (SCANDINAVIAN HEART TRANSPLANT EVEROLIMUS DE NOVO STUDY WITH EARLY CNI AVOIDANCE)

Acronym: CRAD001ANO05

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 12, 2016
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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