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临床试验/NCT03039959
NCT03039959已完成不适用

Predictive Value of Renal Venous Flow Profiles for Adverse Outcomes in Right Heart Failure

University of Giessen1 个研究点 分布在 1 个国家目标入组 421 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
421
试验地点
1
主要终点
Rate of pulmonary hypertension-related morbidity and all-cause mortality (pulmonary hypertension cohort)

研究概览

简要总结

Predictive value of renal venous flow profiles for adverse outcomes in patients with right heart failure

详细描述

Persistent congestion with deteriorating renal function is an important cause of adverse outcomes in heart failure. The investigators aimed to characterize new Doppler ultrasonography approaches to evaluate the continuum of renal congestion. Pulmonary hypertension is the most common precursor to right heart failure and thus represents an ideal scenario to study congestion. The second cohort comprises consecutive Cardiology inpatients aged ≥18 years with a new or pre-existing diagnosis of heart failure who are referred to the consultant nephrologist with a history of diuretic-resistant fluid overload and impaired renal function. The investigators choose patients with heart failure to broaden the findings to the most common clinical entity of right ventricular failure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • CKD stage 5 (KDIGO)
  • pre-existing acute kidney injury (acute kidney injury was defined as an increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours or to ≥ 1.5 times baseline within the prior 7 days, as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
  • Non-end stage renal disease patients with extracorporeal or peritoneal ultrafiltration for treatment of diuretic-resistant fluid overload
  • Patients with primary kidney disease (e.g., glomerulonephritis, autosomal dominant polycystic kidney disease, postrenal obstruction)
  • solid-organ transplant recipients
  • use of non-steroidal inflammatory drugs within 72 hours before right heart catheterization
  • Heart failure cohort:
  • Exclusion criteria same as in the discovery cohort except pre-existing acute kidney injury
  • Patients with mechanical assist devices are excluded

结局指标

主要结局

Rate of pulmonary hypertension-related morbidity and all-cause mortality (pulmonary hypertension cohort)

时间窗: 1 year post-discharge

Any hospitalization for worsening of pulmonary hypertension, lung transplantation, or need for escalation of pulmonary hypertension-specific therapy, and death from any cause

First occurrence of worsening heart failure and first occurrence of need for renal replacement therapy (heart failure cohort)

时间窗: 1 year post-discharge

Unscheduled hospitalization or unscheduled office visit for heart failure and new onset renal replacement therapy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Faeq Husain

Senior Physician Nephrology

University of Giessen

研究点 (1)

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