Status:
COMPLETED
EVOlocumab in Stable Heart Failure With Reduced Ejection Fraction of Ischemic Etiology: EVO-HF Pilot
Lead Sponsor:
Fundació Institut Germans Trias i Pujol
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Evolocumab has been able to reduce the incidence of cardiovascular events in patients that had at least one cardiovascular risk factor \[28\]. In patients with chronic HFrEF, as we mentioned before, t...
Detailed Description
Evolocumab has been able to reduce the incidence of cardiovascular events in patients that had at least one cardiovascular risk factor \[28\]. In patients with chronic HFrEF, as we mentioned before, t...
Eligibility Criteria
Inclusion
- Signing of the informed consent
- Patient ≥18 years and ≤80 years of age
- LVEF \<40%
- Ischemic etiology (evidence of at least one acute coronary event and/or CAD by coronary angiography or multi slice CT)
- New York Heart Association (NYHA) class II
- NT-proBNP ≥ 400 pg/mL
- Hs-TnT \>10 pg/mL
- LDL ≥ 70 mg/dL
- Stable CAD (last ACS before the last 3 months)
- GDMT according to 2016 ESC HF guidelines for at least the last 3 months.
- Statin treatment, whichever dose the patient receives at the time of enrolment, stable for at least 1 month, without need to statin uptitration.
Exclusion
- Extracardiac disease with estimated life expectancy less than 1 year
- Contraindication to receiving evolocumab
- Hypersensitivity to the active substance or to any of the excipients
- 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 \<55 years but no spontaneous menses for ≥2 years, or
- Age \<55 years and spontaneous menses within the past 1 year, but currently amenorrheic, AND with follicle-stimulating hormone (FSH) levels \>40 IU/L or estradiol levels \<5 ng/dL or according to the definition of "postmenopausal range" for the laboratory involved.
- Patient \<18 or ≥ 81 years
- Liver dysfunction (AST or ALT\> 3 times the upper limit of normal value).
- Severe renal dysfunction (estimated glomerular filtration rate \[eGFR\] \< 30 ml/min/1.73m²) or renal replacement therapy at screening (CKD-EPI equation).
- Coronary revascularization in the 3 months prior to randomization or pending coronary revascularization.
- Previous haemorrhagic stroke
- Uncontrolled hypertension (systolic blood pressure ≥ 140 or/and diastolic blood pressure ≥ 90 mmHg) either on or off therapy at screening or at baseline
- Uncontrolled hypothyroidism or hyperthyroidism
- Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (HbA1c \> 8.5%)
- Uncontrolled cardiac arrhythmia
Key Trial Info
Start Date :
December 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03791593
Start Date
December 3 2018
End Date
July 20 2022
Last Update
February 15 2023
Active Locations (3)
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1
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
3
Hospital Clínico de Valencia
Valencia, Spain, 46010