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临床试验/NCT03553810
NCT03553810已完成2 期

Role of ARNi in Ventricular Remodeling in Hypertensive LVH

National Heart Centre Singapore1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年4月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
80
试验地点
1
主要终点
Fibrosis volume

研究概览

简要总结

In Singapore, hypertension is very common in the adult population. Hypertensive heart disease is a leading cause of heart failure and cardiovascular death. Current management relies primarily on achieving blood pressure targets. However, the optimal blood pressure goals are controversial and there are inherent difficulties in measuring blood pressure using external devices applied to peripheral arteries. As a result of (usually longstanding) hypertension, the heart thickens (i.e. hypertrophies) to maintain function. Ultimately, HF may occur due to long standing energy deficits, muscle injury/death and diffuse interstitial fibrosis (heart muscle scarring). In an ongoing study (REMODEL, ClinicalTrial.gov Identifier NCT02670031), we have been able to undertake preliminary analyses with respect to factors associated with the development of fibrosis. In this randomize controlled trial, we will be examining a novel therapy that has the potential to induce regression cardiac hypertrophy and fibrosis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Increased left ventricular mass on cardiovascular magnetic resonance (based on established local age- and sex-specific CMR ranges)
  • Essential hypertension

排除标准

  • Known secondary causes of hypertension
  • Previous intolerance to angiotensin receptor blockers
  • History of heart failure
  • Stage IV/V chronic renal disease (eGFR < 30ml/min/1.73m2)
  • Patients with serum potassium > 5.2 mmol/L (mEg/L) at Visit 1
  • History of cardiovascular events (myocardial infarction, strokes and transient ischemic attacks)
  • Known atrial fibrillation
  • Being unable to understand or comply with study procedures (including CMR)
  • History or presence of any other disease with a life expectancy of < 3 years
  • Pregnant or nursing (lactating) women

研究组 & 干预措施

Treatment Arm

Experimental

Entresto (valsartan/sacubitril) 100mg once a day

干预措施: Entresto (Drug)

Controlled Arm

Active Comparator

Valsartan 40mg once a day

干预措施: Valsartan (Drug)

结局指标

主要结局

Fibrosis volume

时间窗: 52 weeks

A difference in terms of change in interstitial volume from baseline following 52 weeks of treatment. Extracellular volume fraction (ECV) will be quantified from native and post-contrast myocardial T1. Fibrosis volume is defined as ECV x myocardial volume and indexed to body surface area (ml/m2)

次要结局

  • Biomarker/biochemistry(52 weeks)
  • Left ventricular mass measured on CMR(52 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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