EUCTR2015-002928-53-IE进行中（未招募）1 期
Personalised prospective comparison of ARni with ArB in patients with natriuretic peptide eLEvation (PARABLE) - PARABLE
The Heartbeat Trust0 个研究点目标入组 250 人开始时间: 2015年9月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
- •Age > 40yrs with cardiovascular risk factor(s) including at least one of:
- •a. History of hypertension (medicated for greater than one month);
- •b. History of diabetes;
- •BNP between 20 and 280pg/ml or NT-proBNP values between 100 pg/ml and 1,000 pg/ml within 6 months prior to screening
- •LAVI > 28 mL/m2 obtained during Doppler Echocardiography within 6 months prior to screening
- •Subjects must give written informed consent to participate in the study and before any study related assessments are performed
- •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 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
排除标准
- •1.A history of heart failure.
- •2.Asymptomatic left ventricular systolic dysfunction defined as LVEF <50% on most recent measurement.
- •3.Systolic blood pressure <100mmHg
- •4.Persistent atrial fibrillation.
- •5.History of hypersensitivity, allergy or intolerance to LCZ696, ARB or neprilysin therapy or to any of the excipients or other contraindication to their use.
- •6.Previous history of intolerance to recommended target doses for ARBs
- •7.Subjects who require treatment with both an ACE inhibitor and an ARB
- •8.Presence of haemodynamically significant mitral and /or aortic valve disease.
- •9.Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis.
- •10.Conditions that are expected to compromise survival over the study period.
- •11.Serum potassium level > 5.2 mmol/L at screening.
- •12.Severe renal insufficiency (eGFR <30 mL per minute per 1.73 m2).
- •13.Hepatic dysfunction (AST or ALT > 3 times the upper limit of normal (ULN))
- •14.Concomitant use of aliskiren
- •15.History of angioedema.
- •16.History or evidence of drug or alcohol abuse within the last 12 months
- •17.Malignancy or presence of any other disease with a life expectancy of < 2 years
- •18.Women who are pregnant, breast-feeding, or women of child bearing potential not using estro-progestative oral or intra-uterine contraception or implants, or women using estro-progestative oral or intra-uterine contraception or implants but who consider stopping it during the planned duration of the study. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. (Contraception must be continued for one week following discontinuation of study drug).
- •19.Concomitant participation in other intervention trials
- •20.Participation in any investigational drug trial within one month of visit 1.
- •21.Refusal to provide informed consent
- •22.Subjects with contraindications to MRI
- •a)Brain aneurysm clip
- •b)Implanted neural stimulator
- •c)Implanted cardiac pacemaker or defibrillator
- •d)Cochlear implant
- •e)Ocular foreign body (e.g. metal shavings)
- •f)Other implanted medical devices: (e.g. Swan-Ganz catheter)
- •g)Insulin pump
- •h)Metal shrapnel or bullet.
- •23.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs, including but not limited to any of the following:
- •a)History of major gastrointestinal tract surgery including gastrectomy, gastroenterostomy, or bowel resection.
- •b)Inflammatory bowel disease during the 12 months prior to Visit 1.
- •c)Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase.
- •d)Evidence of hepatic disease as determined by any one of the following: SGOT or SGPT values exceeding 3 x ULN at Visit 1, a history of hepatic encephalopathy, a history of oesophageal varices, or a history of portocaval shunt.
研究者
相似试验
尚未招募
4 期
To assess the effect of Arogyavaedhani vati and Kanchanar guggulu in HypothyroidismCTRI/2022/04/042161Ch Brahm Prakash Ayurved Charak Sansthan
终止
不适用
ARNI Versus plAcebo in Patients With Congenital sYStemic Right Ventricle Heart FailureSystemic Right VentricleHeart FailureNCT05117736Montreal Heart Institute15
尚未招募
2 期
To know the efficacy of Amritabhallataka with virechana vs koshthshodhana in patients of Amavata (Rheumatoid Arthritis)CTRI/2023/03/050182ALL INDIA INSTITUE OF AYURVEDA
已完成
不适用
A randomised prospective comparison of two anterior cruciate ligament graft fixation techniquesAnterior cruciate ligament (ACL) graftSurgeryISRCTN67362324Department of Health (UK)80
已完成
不适用
keyhole surgery for pus in chest versus chemical clearance of pus in the chest childreCTRI/2018/03/012403Centre for advance Research Rajiv Gandhi University of Health Sciences Karnataka46