EUCTR2017-000697-11-AT进行中（未招募）1 期
SPIRonolactone In the Treatment of Heart Failure -A double-blind, randomized, placebo-controlled, parallel group, interventional phase III study to evaluate the efficacy and safety of spironolactone compared to placebo on the composite endpoint of recurrent heart failure hospitalizations and cardiovascular death in patients with heart failure with mid- range or preserved ejection fraction
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
- 1,300
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
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •1.Written informed consent
- •2.Male or female, age = 50 years
- •3.Current symptoms of Heart Failure (NYHA = II) on diuretic treatment (any) during VR
- •4.4.Symptom(s) of HF = 30 days prior to VR
- •5.Left ventricular ejection fraction = 40 % at screening measured by echocardiography and evidence of structural/ functional abnormalities (at least one of the following criteria):
- •oLAVI > 34 ml/m2
- •oE/e’mean = 13
- •oMean e’ (septal and lateral) < 9 cm/s
- •6.Patients with at least 1 of the following:
- •a)HF hospitalization (defined as HF listed as the major reason for hospitalization) within 12 months prior to Visit of Screening and NTproBNP >200 pg/ml for patients in SR or >600 pg/ml for patients in AF on screening visit ECG (only if NT-proBNP is not available: BNP > 50/160 pg/ml),
- •b)NT-proBNP >300 pg/ml for patients in SR or >900 pg/ml for patients in AF on the screening visit ECG (only if NT-proBNP is not available: BNP > 80/ 250 pg/ml)
- •(for entering the study a historical measurement of natriuretic peptides within the last 6 months is acceptable)
- •7.Controlled systolic BP: defined as a target systolic BP < 140 mm Hg. Subjects with BP up to and including 160 mm Hg are eligible for enrollment if on 3 or more medications to control BP (Patients with uncontrolled BP should be considered for Re-Screening after optimization of antihypertensive therapy has been established)
- •8.Serum potassium < 5.0 mmol/L prior to randomization
- •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 433
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 867
排除标准
- •1.hyperkalemia (potassium level = 5.5 mmol/L) within the past two weeks before VR
- •2.Hyponatriaemia (Na < 135 mmol/L) prior to randomization
- •3.Severe renal dysfunction, defined as an estimated glomerular filtration rate of less than 30 mL/min/1.73m2) as calculated by the Modification in Diet in Renal Disease (MDRD) formula at VScr/VR or serum creatinine level = 1,8 mg/dl (> 160 µmol/ml)
- •4. History of anuria or acute RF (defined by RIFLE crit. for AKI;3) within past 2 wk before VR
- •5. Acute CS (including MI) and elective PCI within 30 days prior to VR.
- •6.Cardiac surgery, other maj CV surgery, or urgent percutaneous PCI within the 3 months prior to VR
- •7 Current acute decompens. HF requiring augmented therapy with i.v. diuretics, i.v. vasodilators and/or i.v. inotropic drugs. Patients are eligible after initial stabilization.
- •8.Probable alternative diagnoses that in the opinion of the investigator could account for the patient’s HF symptoms (i.e., dyspnea, fatigue) such as significant pulmonary disease (including primary pulmonary HTN), anemia or obesity. Specifically, patients with the following are not randomized:
- •Severe pulmonary disease including COPD or severe asthma bronchiale as requiring continuous corticotherapy or OLD,
- •anemia (hemoglobin < 10 g/d ), or
- •body mass index (BMI) > 40 kg/m2
- •9. Evidence of right sided HF in the absence of left-sided structural heart disease.
- •10.Specific etiologies such as infiltrative, genetic hypertrophic cardiomyopathy, pericardial constriction, sarcoidosis, amyloidosis and any other storage diseases.
- •11.Clinically significant congenital heart disease underlying HF.
- •12. Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and uncontrolled persistent or permanent AF or flutter (with a heart rate > 100 beats per minute (bpm), RACE II) during VR. If AF with HR > 100/min, the patient may be rescreened after treatment for rate control.
- •13. Presence of significant (i.e., more than moderate) valvular heart disease expected to lead to surgery during the trial in the investigators opinion.
- •14. Stroke, transient ischemic attack, carotid surgery or carotid angioplasty within the 3 months prior to VR.
- •15. Coronary or carotid artery disease or valvular heart disease likely to require surgical or percutaneous intervention within the 6 months after VR in the investigators opinion.
- •16. Patients with prior major organ transplant or intent to transplant (on transplant list) or current ventricular assist device (VAD) therapy.
- •17. Evidence of hepatic disease as determined by any one of the following: SGOT (AST) or SGPT (ALT) values exceeding 3x the upper limit of normal (ULN), bilirubin >1.5 mg/dl at VR.
- •18. Presence of bilateral renal artery stenosis.
- •19. Known intolerance or history of hypersensitivity to the active substance (Spironolactone) or to any of the excipients of the IMP or placebo
- •20.Present use of any aldosterone antagonist, potassium supplements or potassium sparing diuretics at the time of enrollment. (Consider stopping these potassium sparing drugs if clinically possible and upon discussion with the patient)
- •21. Required treatment with prohibited Co-medications according to the summary of product characteristics with the exception of ACE inhibitors or angiotensin receptor blockers. Concomitant use not recommended:
- •other potassium-sparing diuretics (alone or combined) (amiloride, potassium canrenoate, triamterene): risk of
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