Sildenafil in Chronic Heart Failure; An investigator initiated multi-national clinical research study. - SilHF

Stavanger Helseforskning AS0 个研究点目标入组 120 人开始时间: 2015年10月8日最近更新: 2018年4月30日

适应症

试验速览

暂无简介。

•1. Men and women
•2. 18 – 80 years of age.
•3. Outpatients with chronic HF. NYHA class III
•4. LVEF < 40%
•5. SPAP >40mmHg using echocardiography
•6. 6MWTD < 475 meters
•7. NT-pro BNP > 400 pg/ml on optimal treatment in sinus rhythm or atrial fibrillation
•8. Receiving optimal therapy, including diuretic, ACE-inhibitor, ARB, beta-blocker and aldosterone antagonist. Doses of all medication should be unchanged during the last 30 days before inclusion.
•9. ICDs and CRTs (CRT-P, CRT-D) are permitted. Implantation should have been performed at > 3 months before inclusion to the trial.
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

•1. Acute Coronary Syndrome, including myocardial infarction, or coronary angiography, with or without intervention, within the last 3 months
•2. Stroke within the last 3 months
•3. Planned coronary angiography or planned device-implantation
•4. Moderate to severe obstructive valve disease
•5. Documented episodes of sustained ventricular tachycardia
•6. Prior or ongoing use of oral nitrate therapy or frequent use of sublingual nitrate
•7. Concomitant disease which interfere with assessment of dyspnoea , severe COPD, asthma, restrictive lung disease, severe obesity
•8. Anemia (hemoglobin < 10g/dL)
•9. Uncontrolled hypertension ( SBP >160 mmHg and / or DBP > 90 mmHg)
•10. Symptomatic or orthostatic hypotension or systolic blood pressure < 90 mmHg
•11. Clinically important renal dysfunction (GFR < 40m ml/min)
•12. Women with child-bearing potential
•13. Prior or ongoing use of
•i) alpha-1 antagonist: doxazosin
•ii) CYP3A4 inhibitors: erytromycin, ritonavir, sakinovir, itrakonazole, ketokonazole
•iii) CYP3A4-inducers: rifampicin
•14. Retinitis pigmentosa, previous diagnosis of NAION (non-arteritic ischemic opticus-neuropathy), unexplained visual disturbance.
•15. Sickle cell anemia, multiple myeloma, leukemia or penile anatomic deformities (angulation, cavernosal fibrosis, Peyronie`s disease) that increases the risk of priapism.
•16. Hepatic failure.

发起方

Stavanger Helseforskning AS