DRKS00014595进行中（未招募）3 期
Phosphodiesterase-5 inhibition in patients with heart failure with preserved ejection fraction and combined post- and pre-capillary pulmonary hypertension (PASSION). A randomized, placebo-controlled, double-blind, parallel group, multi-center, phase III trial - Passion
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Signed written informed consent form
- •2. Capability and willingness to comply with study procedures
- •3. Adult patients = 18 years with a diagnosis of heart failure with preserved ejection fraction and combined post- and pre-capillary pulmonary hypertension assessed by right heart catheterization during the past 12 months
- •4. Diagnosis of HFpEF according to the 2016 heart failure guidelines of the European Society of Cardiology assessed at screening:
- •- History and/or clinical signs of heart failure
- •- Left ventricular ejection fraction =50%
- •- Elevated levels of BNP or NT-proBNP (i.e., =75 ng/L or = 250 ng/L, respectively)
- •- At least one of the following criteria, (i) relevant structural heart disease (left ventricular hypertrophy, i.e. left ventricular septal thickness or posterior wall thickness = 1.1 cm, and/or left atrial enlargement i.e. left atrial volume >58 ml in males or >52 ml in females or left atrial volume index =28 ml/m2, or LA area >20 cm2, or LA diameter >4.0 cm in males or >3.8 cm in females), (ii) echocardiographic signs of diastolic dysfunction
- •5. Hemodynamic criteria:
- •- Pulmonary arterial wedge pressure (PAWP) or left ventricular enddiastolic pressure (LVEDP) >15 mmHg, and
- •- Mean pulmonary artery pressure (PAPm) =25 mmHg, and
- •- Pulmonary vascular resistance (PVR) > 3 WU (240 dyn·s·cm-5)
- •6. NYHA functional class III or IV, or functional class II with at least one heart failure-associated hospitalization during the past 12 months
- •7. Patients on optimized doses of diuretics resulting in the absence of clinically relevant fluid retention
- •8. Ability to perform the 6MWT. Patients with comorbidities affecting the patient's ability to perform the 6MWT but otherwise eligible can be enrolled into the study. These patients will be marked in the CRF and will be excluded from the 6MWT analysis.
- •9. Patients with renal function impairment can be enrolled as long as they do not require renal replacement therapy.
- •10. Patients receiving supplemental oxygen therapy may be included as long as they achieve a resting oxygen saturation =92% with an oxygen flow rate = 4L/min.
- •11. Negative serum/urine pregnancy test in women of childbearing potential
- •12. Patients with reproductive potential must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence could not be practiced, a combination of hormonal contraceptive (oral, injectable, or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used.
排除标准
- •1. Decompensated heart failure at screening
- •Patients with decompensated heart failure cannot be included, but can be re-assessed after recompensation
- •2. Symptomatic coronary heart disease, including percutaneous coronary intervention within the past 3 months or coronary artery bypass surgery within the past 6 months
- •3. Myocardial infarction during the previous 90 days.
- •4. Primary restrictive cardiomyopathy or hypertrophic obstructive cardiomyopathy
- •5. Constrictive pericarditis
- •6. Uncontrolled, severe (life-threatening) arrhythmias
- •7. Hemodynamically relevant aortic or mitral valve disease
- •8. Severe aortic valve regurgitation or moderate or severe aortic valve stenosis
- •9. Severe mitral regurgitation or moderate or severe mitral stenosis
- •10. Severe restrictive or obstructive lung disease indicated by a total lung capacity (TLC) <70% of the predicted value or a forced expiratory volume in 1 second (FEV1) <50% of the predicted value
- •11. Comorbidities that according to the investigator will limit the life expectancy independently from the disease under study (Life expectancy at least > 1 year)
- •12. Transient ischaemic attack or stroke within 3 months prior to screening
- •13. Body mass index =50 kg/m2 at screening
- •14. Previous treatment with phosphodiesterase-5 inhibitors for pulmonary hypertension
- •15. Liver cirrhosis Child-Pugh class C
- •16. Liver dysfunction as indicated by serum bilirubin levels >3 ULN
- •17. Patients with a non-arteritic anterior ischemic optic neuropathy (NAION)
- •18. Hypersensitivity to the active substance (tadalafil) or one the ingredients (see current SmPC)
- •19. Systemic hypotension with blood pressure < 90/50 mmHg at screening
- •20. Uncontrolled hypertension, i.e. RR >180/110 mmHg
- •21. Resting heart rate <48/min and >115/min
- •22. Treatment with nitrates, NO donors or soluble guanylate cyclase stimulators (e.g. riociguat), endothelin receptor antagonists or prostacyclin analogues or prostacyclin receptor agonists within 3 months prior to study entry or during study
- •23. Concomitant therapy with doxazosine
- •24. Concomitant therapy with strong cytochrome P450 inhibitors, such as ketoconazole or itraconazole or P450 inducer, such as Rifampicin
- •25. Concomitant therapy with any PDE5 inhibitor to treat erectile dysfunction
- •26. Breastfeeding
- •27. Participation in another clinical study with other investigational drugs within 30 days prior to randomization
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