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临床试验/EUCTR2017-000697-11-DE
EUCTR2017-000697-11-DE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

Charité Universitätsmedizin Berlin0 个研究点目标入组 1,300 人开始时间: 2017年12月8日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
1,300
研究概览入排标准研究者记录与标识符相似试验

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.Symptom(s) of HF = 30 days prior to VR
  • •5.Left ventricular ejection fraction = 40 % at screening measured by echocardiography or MRI 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
  • •oLeft ventricular mass index (LVMI) = 115 g/m² (m) and =95 g/m² (f)
  • •oSeptal or posterior left ventricular wall thickness = 1.1 cm
  • •oElevated left ventricular end-diastolic pressure (LVEDP) =16 mmHg as determined by invasive measurement
  • •oElevated pulmonary capillary wedge pressure =15 mmHg (resting) or =25 mmHg (exercise) as determined by invasive measurement
  • •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.Serum potassium < 5.2 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 866

排除标准

  • •1.History of hyperkalemia (potassium level = 5.5 mmol/L) within the past two weeks before VR
  • •2.Hyponatremia (sodium level < 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 CKD EPI 2009 formula at VScr/VR or serum creatinine level = 1,8 mg/dl (> 160 µmol/ml)
  • •4.History of anuria or acute renal failure (as defined by the KDIGO 2012 criteria for AKI) within the past two weeks before VR
  • •5.Systolic blood pressure(SBP) =160 mmHg if not on treatment with =3 blood pressure lowering medications or =180 mmHg irrespective of treatments, on 3 consecutive measurements at least 2-minute apart, at screening or at randomization
  • •6.Acute coronary syndrome (including MI), urgent and elective percutaneous coronary intervention (PCI) within 30 days prior to VR. This does not include atrial or ventricular ablations, implantations of pacemakers or event recorders and peripheral percutaneous interventions due to peripheral artery disease.
  • •7.Cardiac surgery and other major CV surgery, within the 3 months prior to VR. This includes percutaneous interventions, such as TAVR, mitral and tricuspid valve clipping or percutaneous reconstruction.
  • •8.Current acute decompensated HF requiring augmented therapy with i.v. diuretics, i.v. vasodilators and/or i.v. inotropic drugs. Patients are eligible after initial stabilization
  • •9.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) or anemia. Specifically, patients with the following are not eligible for randomization:
  • •10.Evidence of right sided HF in the absence of left-sided structural heart disease
  • •11.Specific etiologies such as infiltrative, genetic hypertrophic cardiomyopathy, pericardial constriction, sarcoidosis, amyloidosis and any other storage diseases
  • •12.Clinically significant congenital heart disease underlying heart failure
  • •13.Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and uncontrolled persistent or permanent atrial fibrillation (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
  • •14.Presence of significant (i.e., more than moderate) coronary and / or valvular heart disease expected to lead to surgery during the following 6 months after randomization in the investigators opinion.
  • •15.Stroke, transient ischemic attack, within 3 months prior to VR
  • •16.Patients with prior major organ transplant or intent to transplant (on transplant list) or with current ventricular assist device (VAD) therapy
  • •17.Evidence of present bilateral renal artery stenosis
  • •18.Known intolerance or history of hypersensitivity to the active substance (Spironolactone) or to any of the excipients of the Investigational Medicinal Product (IMP) or placebo
  • •19.Present use of any aldosterone antagonist or potassium sparing diuretics at the time of enrollment. (Consider stopping these potassium sparing drugs if clinically possible and upon discussion with the patient)
  • •20.Required treatment with prohibited Co-medications according to the summary of product characteristics with the exception of ACE inhibitors or angiotensin receptor blockers. Potassium chloride must be used with cauti

研究者

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