EUCTR2007-003070-26-DE进行中（未招募）不适用
Candesartan added” therapy for treatment optimization of symptomatic heart failure with diastolic dysfunction in diabetic and hypertensive patients. A randomized, placebo-controlled, double-blind, parallel-group and multicentre clinical phase III study investigating the effects on NT-proBNP over 6 months. - CAN-DHF
Takeda Pharma GmbH0 个研究点开始时间: 2007年7月10日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •- Male or female patient of at least 45 years of age
- •- Diabetes mellitus type 2 - insulin dependent or orally treated or managed by diet for at least
- •- Normotension or controlled hypertension with sSBP < 140 mmHg and/or sDBP < 90 mmHg
- •- Regular sinus rhythm or atrial fibrillation with a medicamentally achieved rate control of less
- •than 100 bpm as confirmed by ECG-recordings (see also additional criteria 4.4)
- •- Echocardiographic evidence of a preserved LVEF = 45% (assessed by the modified Simpson-
- •method) with further doppler-echocardiographic criteria for diastolic dysfunction grade I-IV.
- •Each grade must be confirmed by 3 of the following 5 parameters
- •(validated for sinus rhythm):
- •Grade E/A DT S/D E/E’ VP_
- •Impaired relaxation (I) =0,75 >220 >1 <10 >45
- •Pseudonormalisation (II) 0,75-1, 5 150-220 <1 =10 <45
- •Restrictive filling (III/IV*) >1,5 =150 <<1 =10 <45
- •* The lack of E/A- reversibility under valsalva manoeuvre connotes grade IV
- •- NYHA-classification of II or III in a stable condition since at least 3 months
- •- Existing background HF-therapy with an ACEI alone or together with further preparations in a
- •constant regimen since at least 1 month, in case of ß-blockers since at least 3 months
- •- NT-proBNP = 220 pg/ml measured at screening visit or collected from a dated previous
- •laboratory document not older than 3 months
- •- No previous therapy with ARBs during the last 4 weeks prior to the study
- •- A woman of childbearing potential must have a negative pregnancy test before study start
- •and must plan not to become pregnant during the study
- •- A woman of non-childbearing potential can be included if she was surgically sterilized or
- •hysterectomized at least three months before study start or when the postmenopausal status
- •was confirmed by a period of amenorrhoe of at least 12 months plus concomitant adequate
- •hormone levels (i.e., FSH > 40 MIE/ml and estrogen < 30 pg/ml or negative estrogen test)
- •- 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
排除标准
- •The following criteria must not be met to enrol a single patient into the study:
- •- 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 > 5.5 mmol/l or HbA1C > 9.5 %
- •- Cor pulmonale or primary pulmonary disease with dyspnea at rest
- •- Known disposition to episodes of symptomatic hypotension or sSBP < 95 mmHg at baseline
- •- Acute coronary syndrome or unstable angina pectoris and any coronary artery disease that
- •was not stable during the last 3 months prior to inclusion
- •- CABG or PTCA (incl. stent implantation) within 3 months before inclusion
- •- Myocardial infarction or stroke within 6 months before inclusion
- •- Patients who are dependent on a permanently paced pacemaker (i.e. a patient with a device
- •that is not pacing during the echocardiographic examination can enter the study)
- •- Open heart surgery for other reasons than coronary revascularization
- •- Tachycardia at rest > 100 bpm as confirmed by ECG-recordings
- •- Known clinically relevant rhythm disorders (e.g., tachyarrhythmias, salves of supraventricular
- •or ventricular extrasystoles or atrial fibrillation without ventricular rate control) or symptoms
- •suggesting a significant rhythm disorder (e.g., recurrent syncopes)
- •- Primary valvular diseases and/or restrictive or obstructive cardiomyopathy
- •- Existing ventricular assist devices
- •- Relevant liver diseases (cholestasis or ALAT/ASAT > 2xULN or ?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
- •- Need for maintenance therapy with NSAIDs or Cox-2-inhibitors
- •- Use of other ARBs throughout the entire study period
- •- Any history of life-threatening diseases
- •- History of drug addiction and/or an extensive use of alcohol
- •- Female patients who are pregnant or breast feeding
- •- Sexually active women of childbearing potential not consistently and correctly practicing
- •highly effective birth control with a low failure rate (less than 1% / year) such as implants,
- •injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual
- •abstinence or vasectomised partner
- •- Psychological and/or emotional problems, which render the informed consent invalid or limit
- •the ability of the patient to comply with the study requirements
- •- Patient is an employee or at least in dependence of the investigator and/or the sponsor or of
- •another institution directly involved in the study or other trials under the investigator's direction
- •- Participation in another clinical investigation within 30 days prior to enrolment or for the course
- •of the present study (incl. studies for compassionate use or experimental medical devices)
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