Candesartan added Treatment for Optimisation of Heart Failure (HF) Therapy - Effects on BNP and other HF associated Parameters.An open, non-controlled and multicentre trial

Takeda Pharma GmbH0 个研究点开始时间: 2004年12月15日最近更新: 2014年2月10日

适应症

试验速览

暂无简介。

•- Male or female patients of at least 18 years of age
•- Heart failure with systolic dysfunction and LVEF = 40% since at least 4 weeks
•without any expected deterioration in the next 4 months according to clinical
•- NYHA classification of II or III in a stable condition since at least 3 months
•- Existing standard HF therapy with an ACE inhibitor alone or together with further
•preparations in a constant regimen since at least 1 month, in case of beta-blockers
•since at least 3 months
•- BNP values at baseline of more than 200 pg/ml
•- No previous therapy with angiotensin-receptor blockers (ARBs) during the last 4
•weeks prior to the study
•- A woman of childbearing potential must have a negative pregnancy test before
•study start, routinely use oral or injectable contraceptives or intrauterine devices
•during the study and plan not to become pregnant during the study
•- A woman of non-childbearing potential could be included if postmenopausal for at
•least one year or surgically sterilised or hysterectomised at least three months
•before study start
•- Available signed written informed consent
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Primary diastolic dysfunction (e.g. amyloidosis or cardiomyopathy)
•- Impaired renal function (serum creatinine > 2.2 mg/dl or > 194 µmol/l)
•- Known bilateral renal artery stenosis (RAS) or interventional treatment for RAS in
•the last year
•- State after kidney transplantation
•- Serum potassium higher than 5.5 mmol/l
•- Known disposition to symptomatic hypotension or sSBP < 95 mmHg at baseline
•- Myocardial infarction, open heart surgery or cerebral event (stroke/TIA) in the last
•- Hemodynamically relevant stenosis of the aortic and/or mitral valve
•- Relevant liver diseases (cholestasis or ALAT/ASAT > 2xULN or Gamma GT > 3xULN)
•- History of primary hyperaldosteronism, of cancer in the last 5 years (exception:
•non metastasizing skin cancer) or of another wasting disease with life expectancy
•of < 2 years
•- Known hypersensitivity to Candesartan Cilexetil
•- Concomitant long-term therapy with NSAIDs or Cox-2-inhibitors
•- Use of other ARBs throughout the entire study period
•- Any history of life-threatening diseases
•- Female patients who are pregnant or breast feeding

发起方

Takeda Pharma GmbH