EUCTR2018-000298-65-PT进行中（未招募）1 期
A randomized parallel-group, placebo-controlled, double-blind, multi-center trial to eValuate the effIcacy and safeTy of the orAL sGC stImulator vericiguaT to improve phYsical functioning in activities of daily living in patients with heart failure and preserved ejection fraction (VITALITY-HFpEF) - VITALITY HFpEF
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 735
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
- •- Previous diagnosis of chronic HF
- •- HF decompensation within 6 months prior to randomization, defined as hospitalization for HF or intravenous (IV) diuretic treatment for HF without hospitalization.
- •- N-terminal pro brain natriuretic peptide (NT-proBNP) =300 or brain natriuretic peptide (BNP) =100 pg/mL in sinus rhythm, or NT-proBNP =600 or BNP =200 pg/mL in atrial fibrillation within 30 days prior to randomization
- •- Diagnostic criteria of HFpEF by echocardiography assessed within 12 months prior to randomization (most recent measurement must be used to determine eligibility with no interim event signaling potential deterioration in ejection fraction)
- •- Left ventricular ejection fraction (LVEF) =45%
- •- Structural changes indicated by at least one of the following parameters:
- •?Left ventricle (LV) hypertrophy (any of the following: intraventricular septal or posterior wall thickness =1.1 cm, and/or LV mass index =115 g/m2 in male and =95 g/m2 in female),
- •?Left atrium (LA) enlargement (any of the following: left atrial volume (LAV) index =29 ml/m2, or LAV >58 mL in male and >52 mL in female patients, or LA area >20 cm2, or LA diameter >40 mm in male and >38 mm in female patients)
- •- NYHA class II or III at 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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 585
排除标准
- •- Clinical instability at randomization, defined by
- •oAny IV treatment within 24h prior to randomization, and/or
- •oSBP =160 mmHg
- •oSBP <110 mmHg and/or DBP <40 mmHg and/or symptomatic hypotension
- •oResting heart rate (HR) <50 or =100 beats per minute (bpm)
- •- Use of IV inotropes at any time between qualifying HF event and randomization
- •- Previous diagnosis of reduced ejection fraction (EF) (EF <40%)
- •- Hypertrophic obstructive cardiomyopathy, acute myocarditis, amyloidosis, sarcoidosis, or pericardial disease
- •- Primary valvular heart disease requiring surgery or intervention, or within 3 months after valvular surgery or intervention, or active endocarditis
- •- Acute coronary syndrome, including unstable angina, Non ST-elevation myocardial infarction or ST-elevation myocardial infarction, or Coronary artery bypass grafting (CABG) within 60 days prior to randomization, or indication for Percutaneous coronary intervention or CABG at the time of randomization
- •- Symptomatic carotid stenosis, or transient ischemic attack or stroke within 60 days prior to randomization
- •- Complex congenital heart disease
- •- Non-cardiac comorbidity (any of the following)
- •- Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m2 calculated by Modification of Diet in Renal Disease formula
- •oHepatic insufficiency classified as Child-Pugh B or C
- •oMorbid obesity with a body mass index >45 kg/m2
- •oMalignancy or other non-cardiac condition limiting life expectancy to <1 year, per physician judgment
- •oRequires continuous home oxygen for severe pulmonary disease or has interstitial lung disease
- •oPatients with allergies, intolerance or hypersensitivity to investigational drug or any of the excipients
- •- Concurrent or anticipated use of nitrates or NO donors, phosphodiesterase type V (PDE5) inhibitors, or a Soluble guanylate cyclase (sGC) stimulator
研究者
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