NL-OMON54576招募中3 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 - SPIRIT*HF DZHK08 (SPIRonolactone In the Treatment of Heart Failure)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
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 64（—）
入选标准
- •1. Written informed consent
- •2. Male or female, age >= 50 years
- •3. Current symptoms of Heart Failure (NYHA >= II) on diuretic treatment (any)
- •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
- •o LAVI > 34 ml/m2
- •o E/e*mean >= 13
- •o Mean e* (septal and lateral) < 9 cm/s
- •o Left ventricular mass index (LVMI) >= 115 g/m² (m) and >=95 g/m² (f)
- •o Septal or posterior left ventricular wall thickness >= 1.1 cm
- •o Elevated left ventricular end-diastolic pressure (LVEDP) >=16 mmHg as
- •determined by
- •invasive measurement
- •o Elevated 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
- •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
- •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
排除标准
- •1. History of hyperkalemia (potassium level >= 5.5 mmol/L) within the past two
- •weeks before
- •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
- •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;
- •see Appendix XVIII.3) within the past two weeks before VR
- •5. Systolic blood pressure(SBP) >=160 mmHg if not on treatment with >=3 blood
- •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
- •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
- •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
- •(including primary pulmonary HTN) or anemia. Specifically, patients with the
- •following are
- •not eligible for randomization:
- •a. Severe pulmonary disease including chronic obstructive pulmonary disease or
- •severe asthma bronchiale or
- •b. anemia (hemoglobin < 10 g/dL males and < 9.5 g/dL females)
- •10. Evidence of right sided HF in the absence of left-sided structural heart
- •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
- •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
- 另有 9 项未显示
研究者
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