EUCTR2015-005615-32-DE进行中（未招募）1 期
A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Effects of 4 Weeks Treatment with Subcutaneous Elamipretide on Left Ventricular Function in Subjects with Stable Heart Failure with Preserved Ejection Fraction
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Age =45 and <80 years.
- •2)Symptomatic heart failure (i.e. NYHA II or III) due to HFpEF for at least 6 months prior to study start
- •3)Evidence of HFpEF: LVEF =45% and E/e´>10 and NT-pro-BNP >220 pg/ml (sinus rhythm) / > 600 pg/mL (atrial fibrillation)
- •4)An exercise-induced increase in E/e' of at least 4 units during stress echocardiography assessment.
- •5) Meeting echocardiographic E/e’ criteria both at screening and at baseline
- •6)Heart failure is considered to be stable, in the judgment of the investigator, and no hospitalization for HFpEF or changes in dose regimen of pharmacologic treatment for HF has occurred within 1 month prior to the Screening Visit.
- •7)Treatment with appropriate pharmacologic therapy to manage underlying risk factors according to current guidelines.
- •8)Ability to complete the study in compliance with the protocol.
- •9)Women of childbearing potential must agree to use 1 of the following methods of birth control from the date they sign the ICF until two months after the last dose of study medication:
- •a)Abstinence, when it is in line with the preferred and usual lifestyle of the subject. Subject agrees to use an acceptable method of contraception should they become sexually active.
- •b)Maintenance of monogamous relationship with a male partner who has been surgically sterilized by vasectomy (the vasectomy procedure must have been conducted at least
- •60 days prior to the Screening Visit or confirmed via sperm analysis).
- •c)Barrier method (e.g., condom or occlusive cap) with spermicidal foam/gel/film/cream (based on non-oil and non-lipid ingredients containing lactic acid or citric acid) AND either hormonal contraception (oral, implanted, or injectable) or an intrauterine device or system.
- •Note: Non-childbearing potential is defined as surgical sterilization (eg, bilateral oophorectomy, hysterectomy, or tubal ligation) or postmenopausal status (defined as permanent cessation of menstruation for at least 12 consecutive months prior to the Screening Visit).
- •10)Women of child-bearing potential must have a negative serum pregnancy test at baseline
- •11)For male subjects with female partners of child-bearing potential, highly effective methods of contraception must be adhered prior to drug administration and for at least 2 months after administration of the last dose of drug. Highly effective methods of contraception are defined as usage by the female partner of any form of hormonal contraception or intra-uterine device (which should be in situ prior to the start of the study) plus usage by one of the partners of an additional spermicide-containing barrier method of contraception.
- •12)Male subjects with pregnant partners must use a condom with spermicide from the start of treatment until at least 2 months after administration of the last dose of drug.
- •13)Subjects must not donate sperm or eggs from the start of treatment until 2 months after the administration of the last dose of drug
- •14)Subject is willing to participate and to provide signed informed consent (ICF) prior to participation in any study-related procedures.
- •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 11
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1)Probable alternative diagnoses that in the opinion of the investigator could account for the patient’s symptoms e.g. severe pulmonary dysfunction or severe asthma as determined by the responsible investigator (COPD class 2 or more), anemia (hemoglobin <10 g/dl), body mass index (BMI) >40 kg/m2
- •2)LVEF <45% (at the moment of enrollment or in medical history)
- •3)Atrial fibrillation as soon as 18 subjects with atrial fibrillation have been randomized into the trial
- •4)Inability to acquire complete echo images (e.g. barrel chested, lung disease, severe obesity)
- •5)Inability to perform stress echocardiography (e.g. severe peripheral artery disease)
- •6)History of any concurrent medical condition which, in the opinion of the Investigator, significantly increases the potential risks associated with administration of study medication or any other aspect of study participation.
- •7)Coronary or peripheral revascularization procedures, valvular procedures, OR any major surgical procedure within 3 months prior to the Screening Visit.
- •8)Acute coronary syndrome (ACS), stroke or transient ischemic attack (TIA) within 3 months prior to the Screening Visit.
- •9)Patients with symptomatic coronary artery disease (CAD)
- •10)Patients presenting with clinically relevant scar burden (>3 segments) at the echo screening resulting in a LVEF <45%
- •11)Restrictive or obstructive cardiomyopathy or pericardial disease.
- •12)Severe valvular heart disease defined as aortic stenosis > grade 2, any degree of mitral stenosis, mitral regurgitation > grade 2, aortic regurgitation >grade 2, tricuspid regurgitation > grade 2, pulmonary stenosis and/or pulmonary regurgitation >grade 1
- •13)Uncontrolled hypertension defined as a systolic blood pressure (BP) >160 mm Hg or a diastolic BP >100 mm Hg on at least 2 consecutive readings that will require a change in anti-hypertensive treatment during the study period.
- •14)Heart rate at randomization visit >= 100 beats per minute
- •15)Presence of second degree or advanced heart block
- •16)Active cancer or undergoing chemotherapy within previous 6 months
- •17)Total bilirubin >2x the upper limit of normal (ULN) in the absence of Gilbert’s Syndrome (M. Meulengracht) and liver enzymes (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] and/or alkaline phosphatase) elevation >3xULN
- •18)Estimated glomerular filtration rate <30 mL/min, by MDRD
- •19)Bleeding diathesis or any known blood dyscrasia.
- •20)Expected survival <1 year in the Investigator’s medical opinion.
- •21)Known active drug or alcohol abuse within 1 year of the Screening Visit.
- •22)Use of other investigational drugs at the time of enrolment, or within 30 days or 5 half- lives of enrolment
- •23)Treatment with spironolactone or eplerenone for less than 3 months at study start
- •24)Treatment with dabigatran
- •25)Treatment with valsartan/sacubitril
- •26)Treatment with trimethazine
- •27)Treament with immunosuppressors
- •28)Treatment with chemotherapeutic drugs
- •29)Female subjects who are pregnant, planning to become pregnant, or lactating.
- •30)Specific contraindications for echo stress testing
- •Absolute contraindications:
- •acute myocardial infarction
- •unstable angina
- •cardiac arrhythmias with symptoms and/or impaired haemodynamics
- •decompensated heart failure
- •acute pulmonary embolism
- •acute myocarditis
- •acute pericarditis
- •acute aortic dissection
- •Relative contraindications:
- •significant left main coronary artery steno
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