EUCTR2009-015638-31-NL进行中（未招募）不适用
An open-label, blinded-endpoint, randomized, prospective trial investigating the effects of vitamin D administration on plasma renin activity in patients with stable chronic heart failure. - VitD-CHF
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •The study population will consist of patients with chronic heart failure (NYHA Class II), = 18 years of age with LVEF = 45 %.
- •Inclusion criteria
- •Out patients = 18 years of age, male or female.
- •Patients with a diagnosis of chronic heart failure (NYHA Class II)
- •LVEF = 45% at visit 1 (local measurement, measured within the past 6 months assessed by echocardiogram, MUGA or ventricular angiography)
- •Patients must be treated with an ACE-i at a stable dose (at least enalapril 10 mg daily or any other ACE-i, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; on equivalent doses, or maximum tolerated dose) or if intolerant to ACE-i with ARB therapy (Candesartan 8 mg daily or any other ARB in equivalent dose, or maximum tolerated dose) for at least 4 weeks prior to visit 1.
- •Patients must be treated with a beta blocker unless contraindicated or not tolerated at a stable dose for at least 4 weeks prior to visit 1 (for patients not on target dose or in absence of that medication, the reason should be documented).
- •Patients must not be treated with an aldosteron receptor antagonist.
- •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
- •Exclusion criteria
- •Concomitant use of ACEi and ARB.
- •Use of aldosteron receptor antagonist.
- •History of hypersensitivity to any of the study drugs.
- •Patients with phenylketonuria.
- •Patients with fructose intolerance.
- •Current acute decompensated heart failure.
- •Hypercalcemia (>2.65 mmol/l, corrected for albumin).
- •Hypercalciuria.
- •Estimated glomerular filtration fraction (GFR) between 30 and 60 ml/min/1.73m2 as measured by the modified of diet in renal disease (MDRD) formula.
- •Nephrolithiasis.
- •Sarcoidosis.
- •Use of the following medication: corticosteroids, thyroxin, anti epileptic drugs, tetracyclines, quinolones
- •Intake of supplements containing vitamin D and/or calcium.
- •Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 3 months.
- •Coronary or carotid artery disease likely to require surgical or PCI.
- •Right heart failure due to severe pulmonary disease.
- •Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the last year.
- •Patients with a history of heart transplant or who are on a transplant list or with LVAD device (left ventricular assistance device).
- •Documented ventricular arrhythmia with syncopal episodes within past 3 months that is untreated.
- •Documented history of ventricular tachycardia or ventricular fibrillation without ICD (internal cardiac defibrillator).
- •Symptomatic bradycardia, or second or third degree heart block without a pacemaker.
- •Implantation of a CRT (cardiac resynchronization therapy) device within prior 3 months.
- •Presence of hemodynamically significant mitral and /or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation.
- •Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis.
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.
- •Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase.
- •Primary liver disease considered to be life threatening.
- •Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit 1.
- •History or presence of any other diseases (i.e. including malignancies) with a life expectancy of < 5 years.
- •Current double-blind treatment in heart failure (HF) trials.
- •Participation in an investigational drug study at the time of enrollment or within the past 30 days or 5 half lives of enrollment whichever is longer.
- •Any surgical or medical condition that in the opinion of the investigator or medical monitor would jeopardize the evaluation of efficacy or safety.
- •History of noncompliance to medical regimens and patients who are considered potentially unreliable.
- •Pregnant or lactating women.
- •Treatment with any of the following drugs within the past 4 weeks prior to Visit 1 (T0): direct renin inhibition including Aliskiren and intravenous vasodilator and/or inotropic drugs.
研究者
相似试验
进行中（未招募）
1 期
A prospective, randomized, open label blinded end point probe trial to evaluate whether, at comparable blood pressure control, combined therapy with the ACE inhibitor Benazepril and the angiotensin II receptor blocker ARB Valsartan reduces progression to ESRD more effectively than Benazepril or Valsartan alone in high risk patients with type 2 diabetes and overt nephropathy VALID Study - VALID StudyDiabetic nephropathyEUCTR2006-005951-14-ITIST. DI RICERCHE FARMACOLOG. M. NEGRI103
进行中（未招募）
1 期
A prospective, randomized, open label blinded end point probe trial to evaluate whether, at comparable blood pressure control, combined therapy with the ACE inhibitor Benazepril and the angiotensin II receptor blocker ARB Valsartan, reduces the incidence of microalbuminuria more effectively than Benazepril or Valsartan alone in hypertensive patients with type 2 diabetes and high-normal albuminuria VARIETY Study - VARIETY StudyDiabetic nephropathyEUCTR2006-005954-62-ITIST. DI RICERCHE FARMACOLOG. M. NEGRI1,233
招募中
3 期
A large-scale trial testing the intensity of CYTOreductive therapy to prevent cardiovascular events In patients with Polycythemia Vera (PV)polycythemia veraTo assess the benefit/risk profile of cytoreductive therapy with phlebotomy and/or hydroxyurea (HU) aimed at maintaining hematocrit (HCT) < 45% Vs. maintaining HCT in the range of 45-50% in patients with PV treated at the best of recommended therapies (e.g., low dose of aspirin when indicated and adequated control of standard cardiovascular risk factors)Blood - Haematological diseasesACTRN12609000046202Consorzio Mario Negri Sud1,000
进行中（未招募）
1 期
Edoxaban treatment versus anticoagulant treatment (here Vitamin K antagonist) in patients with atrial fibrilation undergoing a catheter ablatioSubjects undergoing catheter ablation of non-valvularatrial fibrillationMedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersEUCTR2016-003069-25-PLDaiichi Sankyo Europe GmbH560
进行中（未招募）
1 期
Edoxaban treatment versus anticoagulant treatment (here Vitamin K antagonist) in patients with atrial fibrilation undergoing a catheter ablatioSubjects undergoing catheter ablation of non-valvularatrial fibrillationMedDRA version: 20.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disordersEUCTR2016-003069-25-CZDaiichi Sankyo Europe GmbH560