EUCTR2016-004062-26-IT进行中（未招募）1 期
A multicenter, randomized, placebo-controlled, parallel group, double blind, dose-finding Phase II trial to study the efficacy, safety, pharmacokinetic and pharmacodynamic effects of the oral partial adenosine A1 receptor agonist neladenoson bialanate over 20 weeks in patients with chronic heart failure and preserved ejection fraction - PANACHE - A phase II trial to study neladenoson bialanate over 20 weeks in patients with chronic hea
适应症
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
- 305
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
- •1. Men or women aged 45 years and older
- •2. Diagnosis of chronic heart failure (CHF), NYHA class II-IV (without evidence of a non-cardiac explanation for dyspnea), LVEF = 45% assessed by any imaging modality (e.g. echocardiography, cardiac magnetic resonance, cine levocardiography) within the previous 6 months with no significant change in clinical status suggesting potential for deterioration in ejection fraction.
- •3. In the 6 months prior to run-in:
- •a) Requirement of treatment with a diuretic
- •b) Elevated natriuretic peptides, defined as one of:
- •o BNP = 75 pg/mL or NT-proBNP = 300 pg/mL (sinus rhythm)
- •o BNP = 200 pg/mL or NT-proBNP = 900 pg/mL (atrial fibrillation)
- •c) At least one of the following:
- •o LA enlargement (LA diameter = 3.9 cm, LA volume = 55 mL,
- •LAVI = 29 mL/m2, or LAA = 20 cm2) (assessed by local imaging)
- •o LV hypertrophy (septal or posterior wall thickness = 1.1 cm) (local imaging)
- •o Elevated filling pressures (invasive assessment) at rest (PAWP = 20 mmHg or LVEDP = 15 mmHg) or with exercise (PAWP = 25 mmHg) (historical records)
- •4. 6MWD = 100 m and = 550 m at Visit 2 (baseline)
- •5. Written informed consent signed before any study-specific procedure
- •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 58
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 230
排除标准
- •1. Acute decompensated heart failure (defined as acute exacerbation of HF that may require IV therapy with diuretics, vasodilators or inotropic drugs and¿/¿or mechanical support) within the past 4 weeks
- •2. Initiation or dose modification of cardiovascular pharmacological therapy within the past 2 weeks (dose modification of pre-existing diuretic¿/¿anticoagulant medication is allowed based on patient-specific needs)
- •3. Inability to exercise: wheelchair¿/¿scooter¿/¿walker dependent; dependent on supplemental oxygen
- •4. HF is not the primary factor limiting activity as indicated by the patient affirming #1, #2 or #3 of the following questionnaire:
- •My ability to be active is most limited by:
- •#1 - Joint, foot, leg, hip or back pain
- •#2 - Unsteadiness or dizziness impairing daily mobility
- •#3 - Lifestyle, weather, or I just don’t like to be active
- •5. Previous diagnosis of HFrEF (LVEF < 40%)
- •6. Known clinically significant persistent coronary ischemia (based on medical history, a preexisting or a recent clinical stress test)
- •7. Occurrence of any of the following within 3 months:
- •o Clinically evident myocardial infarction
- •o Hospitalization for unstable angina
- •o Stroke or transient ischemic attack
- •o Coronary artery bypass graft (CABG)
- •o Percutaneous coronary intervention (PCI)
- •o Implantation of a cardiac resynchronization therapy device (CRTD)
- •o Major surgery (that could interfere with patients’ ability to exercise)
- •8. PCI, CABG or implantation of a CRTD planned between randomization and end of study
- •9. Sustained systolic blood pressure = 90 mmHg and¿/¿or signs and symptoms of hypotension prior to randomization
- •10. Sustained¿systolic blood pressure = 160 mmHg prior to randomization
- •11. Sustained¿bradycardia with heart rate < 50 beats/minute or tachycardia with heart rate >¿100 beats/minute prior to randomization
- •12. Known clinically relevant ventricular arrhythmias (sustained ventricular tachycardia, ventricular flutter or fibrillation) within 3 months prior to randomization based on either medical history or device generated data (if applicable)
- •13. Clinically relevant permanent or intermittent AV-block > grade II in patients without a permanent pacemaker or ICD¿/¿CRTD
- •14. Severe uncorrected valvular heart disease
- •15. Listing for heart transplantation and¿/¿or anticipated implantation of a ventricular assist device
- •16. Severe pulmonary disease with any of the following:
- •o Requirement of continuous (home) oxygen or
- •o History of chronic obstructive pulmonary disease = GOLD III
- •o Use of systemic corticosteroids
- •17. Asthma bronchiale with any of the following:
- •o Symptoms not well-controlled within the past 6 months or
- •o Ever intubated or in an intensive care unit for asthma
- •18. Anemia with hemoglobin < 10 g/dL within 3 months prior to randomization. If several values are available the latest result should be used.
- •19. Body mass index (BMI) > 45 kg/m2 at randomization
- •20. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 calculated by Modification of Diet in Renal Disease (MDRD) formula within 3 months prior to randomization (see Appendix 16.1). If several values are available the latest result should be used.
- •21. Hepatic insufficiency classified as Child-Pugh B or C (see Appendix 16.2), or any of the following:
- •o Primary biliary cirrhosis (PBC)
- •o Primary sclerosing cholangitis
- •o PBC-autoimmune hepatitis overlap syndrome
- •22. Concomitant use of any of the following therapy that cannot be discontinued:
- •o Moderate or strong CYP3A4
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