EUCTR2020-000973-26-PT招募中1 期
SOdium-Glucose cotransporter 2 inhibitor, ALDosterone AntagonIst, or both for heart failure with Preserved Ejection Fraction: a two-centre randomised three-treatment three-period crossover trial - Not applicable
Faculdade de Medicina da Universidade do Porto0 个研究点目标入组 108 人开始时间: 2022年2月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
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
- 性别
- All
入选标准
- •1. Provision of informed consent prior to any study specific procedures
- •2. HFpEF diagnosis (irrespective of time from diagnosis)
- •3. Male or female patients, aged =50 years
- •4. NYHA Class II-IV
- •5. LVEF =45%
- •6. NT-pro BNP =220 pg/mL or BNP =80 pg/mL if in sinus rhythm (SR)
- •7. NT-pro BNP =660 pg/mL or BNP =240 pg/mL if in atrial fibrillation (AF)
- •8. Echocardiography with at least one of the following criteria:
- •a. LAVI =29 ml/m2 (=34 ml/m2 if AF)
- •b. Lateral E/e` =9
- •c. LVMI =115 g/m2 If male or =95 g/m2 if female
- •d. LV wall thickness =12mm
- •9. eGFR =30 ml/min/1.73m2 (CKD-EPI formula)
- •10. Blood Potassium =5.5 mmol/L
- •11. Not treated with MRAs and/or SGLT2i within the previous month before inclusion and have no history of diabetic ketoacidosis while in treatment with SGLT2 inhibitors
- •12. Stable/chronic ambulatory patients i.e., patients without need for hospitalization within the last 30 days due to heart failure decompensation episodes
- •13. If female, she must be a woman of non-childbearing potential. That is, she must be:
- •a. Surgically sterilized (e.g. underwent hysterectomy, bilateral salpingectomy or
- •bilateral oophorectomy)
- •b. Clinically diagnosed infertile
- •c. In a post-menopausal state, defined as no menses for 12 months without an
- •alternative medical cause.
- •14. A female patient of childbearing potential must have a negative serum pregnancy test
- •at Visit 1 (Day 0) and must agree to consistently and correctly use (from 28 days prior to first study treatment administration until at least 7 days after last study treatment administration) one of the following highly effective methods of contraception:
- •a. Abstinence of heterosexual intercourse (when this is in line with preferred and usual lifestyle of the subject)
- •b. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- •c. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- •d. Intrauterine device
- •e. Intrauterine hormone-releasing system
- •f. Bilateral tubal occlusion
- •g. Vasectomized partner, who has received medical assessment of the surgical success, or clinically diagnosed infertile partner
- •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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •1. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- •2. Participation in another clinical study with an investigational product during the last month
- •3. Unwilling or unable to sign the informed consent form
- •4. Surgical procedure, coronary, cerebral or peripheral vascular events or sepsis in the prior 90 days
- •5. Cancer (life-limiting or less than 2 years in remission)
- •6. Any previously confirmed autoimmune disease
- •7. Type 1 Diabetes
- •8. Severe hepatic impairment (Child-Pugh class C)
- •9. Ability to walk is, in the investigator’s opinion, clearly limited by joint disease or other locomotor problems or lung diseases rather than by cardiorespiratory fitness
- •10. Previously confirmed cardiac amyloidosis
- •11. Severe valvulopathy according to the echocardiogram report
- •12. Patients with a known hypersensitivity or intolerance to spironolactone or dapagliflozin or any of the excipients of the products.
- •13. Female patients currently pregnant (confirmed by a positive pregnancy test) or intent to become pregnant or breast feeding.
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