CTRI/2023/06/053508招募中3 期
HERMES: Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heartfailure with mildly reduced or preserved ejection fraction and systemic inflammation. - HERMES_EX6018-4915
ovo Nordisk India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •All inclusion criteria are based on the participants’ medical records, except for inclusion criteria #3
- •(hs-CRP at central laboratory), #4 (NT-proBNP at central laboratory, and ECG assessed at
- •screening) and #5 (NYHA class) assessed at screening (visit 1).
- •Local requirements may apply. China, Czech Republic, France, Germany, Hungary, Lithuania,
- •Netherlands, Portugal, Singapore, South Korea, Spain, Taiwan: see country/region-specific
- •requirements (Appendix 11, Section 10.11).
- •Participants are eligible to be included in the study only if all the following criteria apply:
- •1. Informed consent obtained before any study-related activities. Study-related activities are any
- •procedures that are carried out as part of the study, including activities to determine suitability
- •for the study.
- •2. Age 18 years or above at the time of signing the informed consent.
- •3. Serum hs-CRP ?2 mg/L at screening (visit 1).a
- •Disease specific - cardiovascular
- •4. At least one of the followinga:
- •a. NT-proBNP = 300 pg/mL at screening (Visit 1) for patients without ongoing atrial
- •fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NTproBNP
- •must be = 600 pg/mL.
- •b. HF hospitalisation or urgent/unplanned visit with a primary diagnosis of
- •decompensated heart failure which required intravenous loop diuretic treatment,
- •within the last 9 months prior to screening (visit 1) in combination with NT-proBNP
- •= 200 pg/mL at screening (Visit 1) for patients without ongoing atrial
- •fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NTproBNP
- •must be = 600 pg/mL.
- •5. Diagnosis of heart failure (NYHA Class II-IV).
- •6. LVEF > 40% documented by echocardiography within 12 months prior to or at screening
- •(visit 1). The LVEF must be documented in medical records and the most recent measurement
- •must be used to determine eligibility with no interim event signalling potential deterioration in
- •ejection fraction (e.g., MI or HF hospitalisation).
- •7. Structural heart disease and/or functional heart disease documented by echocardiography within
- •12 months prior to or at screening (visit 1) showing at least one of the following:
- •o LA volume index > 34 mL/m2.
- •o LA diameter = 3.8 cm.
- •o LA length = 5.0 cm.
- •o LA area = 20 cm2.
- •o LA volume = 55 mL.
- •o Intraventricular septal thickness =1.1 cm.
- •o Posterior wall thickness =1.1 cm.
- •o LV mass index =115 g ? m2 in men or = 95 g ? m2 in women.
- •o E/e’ (mean septal and lateral) = 10.
- •o e’ (mean septal and lateral) < 9 cm/s.
- •8. No heart failure hospitalisations or urgent heart failure visits between screening (visit 1) and
- •randomisation (visit 2).
- •a Patients participating in the prevalence study (NN6018-7527) may be enrolled based on the hs-
- •CRP and/or NT-proBNP (requiring corresponding ECG from the same date) results obtained in the
- •study, if no more than 90 days old.
- •Local requirements may apply. Germany, South Korea: see country/region-specific requirements
- •(Appendix 11, Section 10.11).
排除标准
- •All exclusion criteria are based on the participants’ medical records, except for exclusion criterion
- •#3 (urine pregnancy test), criteria #9 to #12 and #27 (central laboratory tests), criteria #26 (central
- •laboratory tests, if applicable), criterion #14 (blood pressure) and criterion #15 (ECG).
- •Local requirements may apply. Argentina, Austria, Belgium, Brazil, China, Czech Republic,
- •Denmark, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Lithuania, Norway, Poland,
- •Portugal, Romania, South Korea, Spain, Thailand, UK: see country/region-specific requirements
- •(Appendix 11, Section 10.11).
- •Participants are excluded from the study if any of the following criteria apply:
- •1. Known or suspected hypersensitivity to study intervention or related products.
- •2. Previous randomisation in this study.
- •3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing
- •potential and not using a highly effective contraceptive method, as defined in Appendix 4
- •(Section 10.4.2).
- •4. Participation (i.e., signed informed consent) in any other interventional clinical study of an
- •approved or non-approved investigational medicinal product within 30 days prior to screening
- •(visit 1).
- •5. Participation in any clinical study of an approved or non-approved device for the treatment of
- •heart failure within 30 days prior to screening (visit 1).
- •6. Any disorder, which in the investigator’s opinion might jeopardise participant’s safety or
- •compliance with the protocol.
- •7. Inadequate standard of care treatment which in the investigator’s opinion makes participation in
- •the study inappropriate.
- •8. Unstable medical therapy for heart failure (including dose of diuretics) within 14 days prior to
- •screening visit (visit 1) (at the discretion of the investigator).
- •Laboratory values
- •9. Absolute neutrophil count <2×109/L at screening (visit 1).
- •10. Platelet count <120×109/L at screening (visit 1).
- •11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 × upper limit of
- •normal at screening (visit 1).
- •12. Active hepatitis C (positive anti-HCV and detectable HCV RNA) or hepatitis B (positive
- •HBsAg and/or positive anti-HBc with detectable HBV DNA) at screening (visit 1). (Note:
- •Participants with positive anti-HBc and undetectable HBV DNA can be enrolled; see
- •Section 8.2.8 for details).
- •Medical conditions – cardiovascular
- •13. Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart
- •failure hospitalisation within 30 days prior to screening (visit 1).
- •14. Systolic blood pressure =180 mmHg at screening (visit 1). If the systolic blood pressure is 160-
- •179 mmHg, the patient should be receiving =3 antihypertensive drugs. (Note: Potential
- •participants may be retested for this criterion within the visit window and without rescreening,
- •at the discretion of the investigator).
- •15. Heart rate above 110 or below 40 beats per minute as evaluated on the ECG performed at
- •screening (visit 1) (Note: Potential participants may be retested for this criterion within the visit
- •window and without rescreening, at the discretion of the investigator).
- •16. Planned coronary, carotid or peripheral artery revascu
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