stable coronary artery disease and stable heart failure with reduced ejection fraction MedDRA version: 20.0 Level: LLT Classification code 10078289 Term: Heart failure with reduced ejection fraction System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Repatha
Product Name: EVOLOCUMAB
Pharmaceutical Form: Solution for injection
INN or Proposed INN: EVOLOCUMAB
Other descriptive name: EVOLOCUMAB
Concentration unit: mg milligram(s)
Concentr
Sponsors
Instituto de Investigación en Ciencias de la Salud Germans Trias i Pujol (IGTP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signing of the informed consent 2. Patient =18 years and =80 years of age 3. LVEF 14 pg/mL 8. LDL = 100 mg/dL 9. Stable CAD (last ACS before the last 3 months) 10. GDMT according to 2016 ESC HF guidelines for at least the last 3 months. 11. Statin treatment, whichever dose the patient receives at the time of enrolment, stable for at least 1 month, without need to statin uptitration 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 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: 1. Extracardiac disease with estimated life expectancy less than 1 year 2. Contraindication to receiving evolocumab 3. Hypersensitivity to the active substance or to any of the excipients 4. Female subject who has not used an acceptable method of birth control for at least 1 month prior to screening and/or is not willing to inform her partner of her participation in this clinical trial and to use an acceptable method of effective birth control during treatment with evolocumab and for an additional 15 weeks after the end of treatment with evolocumab, unless the female subject is permanently sterilized or postmenopausal: A female is considered of childbearing potential unless permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or postmenopausal with menopause defined as: - Age =55 years and =12 months of spontaneous and continuous amenorrhea, or - Age 40 IU/L or estradiol levels 3 times the upper limit of normal value). 7. Severe renal dysfunction (estimated glomerular filtration rate [eGFR] 8.5%) 13. Uncontrolled cardiac arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess if LDL-C lowering at 1 year with monthly subcutaneous (SC) evolocumab 420 mg for 1 year will result in a significant reduction of high-sensitivity troponin T (hs-TnT), surrogate marker of myocyte injury and atherosclerosis progression, compared with current Standard of care (SOC) in subjects with elevated LDL-C, stable coronary artery disease (CAD) and stable heart failure with reduced ejection fraction (HFrEF).;Secondary Objective: To assess change of high-sensitivity troponin T (hs-TnT) after 6 months of treatment with monthly SC evolocumab 420 mg To assess change of NT-proBNP, ST2, and hs-CRP levels after 6 and 12 months of treatment with monthly SC evolocumab 420 mg To assess change of LDL, LDLR, HDL, and sPCSK9 levels after 6 and 12 months of treatment with monthly SC evolocumab 420 mg To evaluate change in exercise tolerance in patients with stable Heart Failure with reduced ejection fraction of ischemic etiology at 6 months and 1 year To evaluate change in quality of life Using Kansas city cardiomyopathy questionnaire (KCCQ) at 6 months and 1 year To evaluate the safety profile of evolocumab administered together with top of guideline-driven medical treatment Biomarkers will be used to elucidate the effects of evolocumab as well as to perform exploratory correlational analysis to assess their interactions and roles within the mediation of study-drug effects on cardiac remodeling.;Primary end point(s): The primary endpoint of this study is the change in hs-TnT levels at 1 year;Timepoint(s) of evaluation of this end point: at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in Hs-TnT levels at 6 months • Change in NT-proBNP, ST2, and hs-CRP levels at 6 months and 1 year • Change in LDL, LDLR, HDL, and sPCSK9 levels at 6 months and 1 year • Change in 6 minutes walking test at 6 months and 1 year • Change in quality of life test (KCCQ) at 6 months and 1 year • Number and percentage of AEs;Timepoint(s) of evaluation of this end point: at 6 months and 1 year | — |
Countries
Spain
Contacts
Public ContactCristina Herrero
FLS-Reseach Support
Outcome results
None listed