EUCTR2020-005878-10-PL进行中（未招募）1 期
A Double-Blind, Placebo-Controlled, Randomized, Multicenter, Phase 2 Study assessing the Safety, Tolerability and Efficacy of IONIS-AGT-LRX, an Antisense Inhibitor of Angiotensinogen Production, Administered Subcutaneously over 12 Weeks in Patients with Chronic Heart Failure with Reduced Ejection Fraction - ASTRAAS-HF (ASO Targeting the RAAS System for Heart Failure)
Ionis Pharmaceuticals0 个研究点目标入组 72 人开始时间: 2021年4月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
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. Satisfy the following:
- •Females must be non-pregnant and non-lactating and of non-childbearing potential. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential (WOCBP), she must be willing to use a highly effective contraceptive method
- •2. Screening NT-proBNP = 600 picograms per milliliter (pg/mL) and less than (<) 8500 pg/mL. For participants in atrial fibrillation at screening the eligibility NT-proBNP value is = 1200 pg/mL and < 10200 pg/mL.
- •3. Established diagnosis of heart failure (HF) with reduced systolic function for at least 6 months prior to the screening visit (left ventricular ejection fraction, [LVEF] = 40%
- •4. New York Heart Association class I-III
- •5. Participants should receive background standard of care for HFrEF. Therapy should have been individually optimized and stable for = 4 weeks before screening and include:
- •a. An angiotensin-converting-enzyme inhibitor (ACEi), or angiotensin II receptor blockers (ARBs) or sacubitril/valsartan (mandatory);
- •b. A beta-blocker (unless contraindicated or not tolerated).
- •c. A mineralocorticoid receptor antagonist (MRA, unless contraindicated or not tolerated).
- •d. A sodium glucose co-transporter 2 inhibitor(SGLT2i) (unless contraindicated or not tolerated).
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 47
排除标准
- •1. HF due to restrictive cardiomyopathy, active myocarditis, chemotherapy, hypertrophic cardiomyopathy, primary cardiac valve disease, non-compaction cardiomyopathy and takotsubo cardiomyopathy
- •2. Acute decompensated HF requiring intravenous (IV) diuretics, IV inotropes or IV vasodilators with discharge date within 30 days of screening or acute mechanical support (e.g., intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) with discharge date within 90 days of screening.
- •3. Symptomatic hypotension or systolic blood pressure (SBP) = 90 millimeters of mercury (mmHg) at screening.
- •4. Heart transplant, and/or Left Ventricular Assist Device (LVAD) prior to screening or anticipated heart transplant or LVAD during the study.
- •5. Implantation of a cardiac resynchronization therapy device (CRT) within 3 months prior screening or intent to implant a CRT within 3 months after screening.
- •6. Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac device implantation, cardiac valve repair, carotid or other major surgery within 3 months of screening.
- •7. Coronary, valve or carotid artery disease likely to require surgical or percutaneous intervention within the 3 months after screening.
- •8. Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion in the opinion of the investigator.
- •a. Estimated glomerular filtration rate (eGFR) < 30 milliliters/minute /1.73 m^2 (mL/min/1.73 meter^2) at screening [Chronic kidney disease epidemiology collaboration (CKD-EPI formula)
- •b. Serum potassium > 5.1 millimoles per liter (mmol/L) at screening.
- •9. Requirement of treatment with both ACEi and ARBs.
- •10. Previous history of intolerance to ACEi or ARBs or history of hyperkalemia as per Investigator's judgement.
研究者
相似试验
进行中（未招募）
1 期
Trial comparing Standard Treatment in the ICU with ADRECIZUMAB Treatment in patients with septic shock and elevated AdrenomedulliMedDRA version: 20.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestationsSeptic ShockEUCTR2016-003883-38-DEAdrenomed AG300
进行中（未招募）
1 期
Trial comparing Standard Treatment in the ICU with ADRECIZUMAB Treatment in patients with septic shock and elevated AdrenomedulliMedDRA version: 20.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestationsSeptic ShockEUCTR2016-003883-38-BEAdrenomed AG300
进行中（未招募）
1 期
A Double-Blind, Placebo-Controlled, Randomized, Multiple Ascending Dose, Safety Study of MYO-029 Administered to Adult Patients with Becker, Facioscapulohumeral and Limb-Girdle Muscular Dystrophy.Becker Muscular Dystrophy, Facioscapulohumeral Muscular Dystrophy, Limb-Girdle Muscular Dystrophy.EUCTR2004-000622-67-GBWyeth Research Division of Wyeth Pharmaceuticals Inc.136
进行中（未招募）
2 期
Medical expulsive effect using TadalafilreterolithiasisJPRN-jRCT2031190051Arai Seiji50
已完成
2 期
A Double-Blind, Placebo-Controlled, Randomized, Multicenter, Proof of Concept and Dose-Finding Phase II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of ADRECIZUMAB in Patients with Septic Shock and Elevated AdrenomedulliOrgaandisfunctieblood poisoning - sepsis10019815NL-OMON48885Adrenomed AG50