NL-OMON51825尚未招募2 期
Feasibility of empagliflozin as treatment for idiopathic pulmonary arterial hypertension - EMPHOWER proof-of-concept
Amsterdam UMC, locatie VUmc0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 18 years
- •2. Diagnosis of idiopathic PAH
- •3. Documented diagnostic right heart catheterization (RHC) at any time prior to
- •screening confirming diagnosis of WHO diagnostic pulmonary hypertension Group
- •I: PAH with subtype idiopathic PAH. The documented RHC shows all of the
- •following criteria:
- •a. mPAP > 20 mmHg at rest
- •b. Pulmonary artery wedge pressure (PAWP) or left ventricular end-diastolic
- •pressure (LVEDP) <= 15 mmHg at rest
- •c. PVR >= 240 dyn·sec/cm5 (3 Wood units) at rest
- •4. Symptomatic pulmonary hypertension classified as World Health Organization
- •(WHO) functional class (FC) II, III or IV
- •5. PAH therapy is at stable (per investigator) dose levels of standard of care
- •(SoC) therapies for at least 90 days prior screening. SoC therapy refers to a
- •therapy consisting of at least 1 agent from a list including: an
- •endothelin-receptor antagonist (ERA), a phosphodiesterase 5 (PDE5) inhibitor, a
- •soluble guanylate cyclase stimulator, and/or a prostacyclin analogue or
- •receptor agonist (SC/inhaled/PO).
排除标准
- •1. Any subject who received any investigational medication within 1 month prior
- •to the start of this study or who is scheduled to receive another
- •investigational drug during the course of this study. Patients participating in
- •a purely observational trial will not be excluded
- •2. Females of childbearing potential, defined as a sexually mature woman who:
- •1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not
- •been naturally postmenopausal (amenorrhea following cancer therapy does not
- •rule out childbearing potential) for at least 24 consecutive months (i.e., has
- •had menses at any time in the preceding 24 months), unable or unwillingly to
- •a. Use highly effective methods of birth control according to the International
- •Conference on harmonisation of pharmaceuticals for human use (ICH) that result
- •in a low failure rate of less than 1% per year when used consistently and
- •correctly 43. Highly effective methods include hormonal contraception (for
- •example, birth control pills, injection, implant, transdermal patch, vaginal
- •ring); intrauterine device (IUD); tubal ligation (having your tubes tied); or a
- •partner with a vasectomy who has completed follow-up to confirm a successful
- •b. Have a negative pregnancy tests as verified by the investigator prior to
- •starting study therapy and agrees to have an extra pregnancy test 8 weeks after
- •start of the study
- •3. Contraindication for CMR imaging as defined in the protocol of the Amsterdam
- •UMC *Kwaliteitsdocument Cardiale MRI (Versie 1)*. The list of
- •contra-indications includes: claustrophobia, ferromagnetic implants, implanted
- •cardioverter defibrillator (ICD) or pacemaker (except for the MR conditional)
- •and ball-in-cage mechanic heart valve.
- •4. Impaired renal function, defined as eGFR < 30 mL/min/1.73 m2 (CKD-EPI) or
- •requiring dialysis
- •5. History of chronic severe (Child Pugh classification score >10, Appendix 1)
- •or active liver disease defined as serums transaminases >5 x upper limit of
- •normal (ULN) or bilirubin > 1.5 x ULN
- •6. History of ketoacidosis
- •7. Known allergy, intolerance or hypersensitivity to empagliflozin or other
- •SGLT-2 inhibitors
- •8. Use of lithium compounds and being unable or unwillingly to increase the
- •monitoring frequency of lithium levels
- •9. Current or scheduled use of the following Uridine glucuronosyltransferase
- •(UGT) inducers: phenytoin, rifampicin, carbamazepine, lamotrigine, ritonavir,
- •efavirenz, tipranavir, phenobarbital, testosterone propionate and nelfinavir.
- •10. Current or prior use of a SGLT-2 inhibitor
- •11. Heart transplant recipient or listed for heart transplant
- •12. Chronic pulmonary disease requiring home oxygen or steroid maintenance
- •13. Symptomatic hypotension and/or a systolic blood pressure (SBP) < 90 mmHg at
- •14. Gastrointestinal (GI) surgery or GI disorder that could interfere with
- •absorption of trial medication in the investigator*s opinion
- •15. Presence of any other disease than pulmonary arterial hypertension with a
- •life expectancy of <1 year in the investigator*s opinion
- •16. Women who are pregnant, nursing, or who plan to become pregnant while in
- •17. History of severe (previously required or prolonged patient
- •hospitalization, resulted in persistent or marked disability/incapacity) or
- •recurrent (>=2 infections in si
研究者
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