Combination of Organic Nitrates and Hydralazine in the Management of Symptoms in Patients With Systolic Heart Failure Receiving Contemporary Neurohormonal Inhibition.

Alphapharm0 个研究点目标入组 160 人开始时间: 2007年5月18日最近更新: 2020年1月13日

适应症

试验速览

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•2.Chronic heart failure class II, III or IV New York Heart Association for > 3 months3. Left Ventricle Ejection Fraction <=40% (within 3 months of entry to the study)4. Stable medical therapy >3 months (including Beta Blocker, Angiotensin Converting Enzyme Inhibitor or Angiotensin Receptor Blocker and Spironolactone or Eplerenone if applicable. This inclusion criteria excludes Frusemide because Frusemide dosage may vary daily depending on medical advice.)5. Women of childbearing potential must be willing to use effective contraceptives to prevent pregnancy during the course of the study.6. Women of child-bearing potential must have a negative pregnancy before randomisation.

•1. Cardiogenic shock 2. Unstable coronary syndrome within 3/123. Recent myocardial infarction (3/12)4. Severe aortic stenosis5. Severe symptomatic coronary artery disease6. Restrictive cardiomyopathy, constrictive pericarditis7. Hypotension (mean Blood Pressure <80mmHg)8. Significant renal impairment with creatinine >200 mcmol/l 9. Unable to provide consent, comply with follow-up visits and/or respond to the questionnaire10. Currently involved in or has been involved in another clinical trial using an investigational drug or device in the previous 30 days.

发起方

Alphapharm