EUCTR2020-003126-23-LT进行中（未招募）1 期
A Phase 2b, Randomised, Double-Blind, Active-Controlled, Multi CentreStudy to Evaluate the Efficacy, Safety and Tolerability of Oral AZD9977 andDapagliflozin Treatment in Patients with Heart Failure and Chronic Kidney Disease - MIRACLE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
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 Participant must be 21 years of age or older, at the time of signing the
- •informed consent.
- •2 Documented diagnosis of stable symptomatic HF (NYHA class II-III) at
- •screening (Visit 1a), and a medical history of typical symptoms and signs
- •of HF in those who are currently receiving loop diuretic treatment.
- •3 Left ventricular ejection fraction <60% documented by the most
- •recent echocardiogram 2D or 3D or cardiac magnetic resonance imaging
- •within the last 12 months prior to screening.
- •4 Patients should be treated for HF, hypertension, T2DM or
- •renal disease according to guidelines.
- •5 NT-proBNP =300 pg/mL for patients with sinus rhythm at screening ;
- •and NT-proBNP =600 pg/mL for patients with atrial fibrillation/flutter at
- •screening or using local laboratory sample.
- •6 eGFR =30 and =60 mL/min/1.73m2 (by CKD-EPI formula) based on local laboratory sample.
- •7 UACR at screening: spot urine sample analysed at local laboratory = 30
- •mg/g (3 mg/mmol) and < 3000 mg/g (300 mg/mmol) for participants
- •on SGLT2i; spot urine sample analysed at local laboratory = 50 mg/g (5
- •mg/mmol) and < 3000 mg/g (300 mg/mmol) for participants not on
- •8 Body mass index less than 40 kg/m2 .
- •9 Male or female of non-childbearing potential.
- •10 Female patients must be of non-childbearing potential.
- •Women of non-childbearing potential are defined as women who are
- •either permanently sterilised (hysterectomy, bilateral oophorectomy, or
- •bilateral salpingectomy), or who are postmenopausal. Women will be
- •considered postmenopausal if they have been amenorrhoeic for 12
- •months prior to the planned date of randomisation without an
- •alternative medical cause. The following age-specific requirements
- •(a) Women <50 years old would be considered postmenopausal if they
- •have been amenorrhoeic for 12 months or more following cessation of
- •exogenous hormonal treatment and FSH levels in the postmenopausal
- •(b) Women =50 years old would be considered postmenopausal if they
- •have been amenorrhoeic for 12 months or more following cessation of all
- •exogenous hormonal treatment.
- •11 Male patients must be surgically sterile or using, in conjunction with
- •their female partner, a highly effective method of contraception for the
- •duration of the study (from the time they sign consent) and for 3 months
- •after the last dose of study drug to prevent pregnancy in a partner. Male
- •study participants must not donate or bank sperm during this same time
- •12 Capable of giving signed informed consent as described in Appendix A
- •which includes compliance with the requirements and restrictions listed
- •in the ICF and in this protocol.
- •13 Provision of signed and dated, written ICF prior to any mandatory
- •study specific procedures, sampling, and analyses. NOTE: For the optional pre-
- •screening visit there is a separate informed consent. Refer to Section 4.1.1
- •14 Provision of signed and dated written Optional Genetic Research
- •Information informed consent prior to collection of samples for optional
- •genetic research that supports Genomic Initiative.
- •Participants are eligible to be randomised in the study only if all of the
- •following criteria apply at randomisation (Visit 3):
- •15 eGFR = 30 mL/min/1.73 m2 (by CKD-EPI formula at central
- 另有 5 项未显示
排除标准
- •1 Primary glomerulopathy, vasculitic renal disease, prior dialysis or
- •unstable rapidly progressing renal disease, autosomal dominant or
- •autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-
- •associated vasculitis.
- •2 Patients with currently decompensated unstable HF requiring
- •hospitalisation for optimisation of HF treatment and not on stable HF
- •therapy at the time of enrolment.
- •3 HF due to cardiomyopathies that would primarily require specific other
- •treatment such as cardiomyopathy due to amyloidosis or infiltrative
- •diseases, primary hypertrophic cardiomyopathy, cardiomyopathy related
- •to current toxic or infective conditions.
- •4 High output HF.
- •5 HF due to pericardial disease, congenital heart disease or clinically
- •significant uncorrected primary cardiac valvular disease, or planned
- •cardiac valve repair/replacement.
- •6 Patients with uncontrolled diabetes mellitus (HbA1c >10%).
- •7 Patients with T1DM.
- •8 Intermittent or persistent 2nd or 3rd degree atrioventricular block,
- •sinus node dysfunction with clinically significant bradycardia or sinus
- •pauses, not treated with a pacemaker.
- •9 Known congenital long QT syndrome or history of QT prolongation
- •associated with other medications.
- •10 History of any life-threatening cardiac dysrhythmia or uncontrolled
- •ventricular rate in patients with atrial fibrillation or atrial flutter.
- •11 Acute coronary syndrome and/or elective/non-elective percutaneous
- •cardiac interventions (within 3 months) prior to randomisation or is
- •planned to undergo any of these procedures during the study.
- •12 Any major cardiovascular or major non-cardiovascular surgery within
- •3 months prior to randomisation or is planned to undergo any of these
- •procedures during the study.
- •13 Heart transplantation or left ventricular assist device at any time or if
- •these are planned.
- •14 Kidney or any organ transplantation or if these are planned.
- •15Addison's disease.
- •16 History or ongoing allergy/hypersensitivity to SGLT2i.
- •17 Any clinically significant disease or disorder which, as judged by the
- •investigator, might put the patient at risk because of participation in the
- •study, or probable alternative primary reason for patient's symptoms in
- •judgement of investigator, including but not limited to:
- •(a) Isolated pulmonary arterial hypertension (PAP=25 mmHg at rest) or
- •right ventricular failure; in the absence of left-sided HF.
- •(b) Anaemia defined as haemoglobin level <100g/l or 10g/dl at
- •time of screening (Visit 1a).
- •(c) Severe chronic obstructive pulmonary disease or other lung disease
- •including but not limited to pulmonary fibrosis requiring chronic
- •oxygen therapy, regular nebuliser use or oral steroid therapy.
- •18 Stroke, transient ischaemic attack, carotid surgery or carotid
- •angioplasty within previous 3 months prior to randomisation.
- •19 Active malignancy requiring treatment (except for basal cell or
- •squamous cell carcinomas of the skin).
- 另有 11 项未显示
研究者
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