Association Between Biomarkers and Kidney Function Decline in Patients With Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Major adverse kidney events
研究概览
简要总结
The objective of this study is to examine the association between urinary and plasma biomarkers and change in estimated glomerular filtration rate (eGFR) among patients with pulmonary hypertension (PH).
详细描述
PH is a severe, progressive disease associated with right ventricular dysfunction, right-sided heart failure (HF) and death. Kidney disease is present in approximately 35% of patients with PH, and its presence is associated with an enhanced risk for adverse outcomes, with the risk increasing incrementally with declining kidney function. Poor right ventricular function may increase venous congestion, alter ventricular interdependence, decrease effective cardiac output and activate the renin-angiotensin- aldosterone system, thereby aggravating kidney disease.
There is a crucial need to better understand the pathophysiological mechanisms linking the failing right heart and the kidney. To date, diagnostic and prognostic biomarkers of kidney disease in PH are lacking. The objective of this study is to examine the association between urinary and plasma biomarkers and change in eGFR among patients with PH.
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
- 是
入选标准
- •Inpatients aged ≥18 years
- •Undergoing right heart catheterization (RHC)
排除标准
- •multifactorial or indeterminate PH, for which no single underlying mechanism could be reliably classified
- •active tumor disease requiring targeted therapy
- •inflammatory or autoimmune disease with renal involvement requiring systemic immunosuppressive treatment
- •unexplained kidney function decline, defined as serum creatinine increase ≥0.5 mg/dL from baseline within the prior 7 days before RHC
- •Chronic kidney disease with eGFR <20 ml/min/1.73 m2
- •non-kidney failure requiring extracorporeal or peritoneal ultrafiltration for diuretic-resistant volume overload
- •if they had received non-steroidal anti-inflammatory drugs or intravenous contrast within 72 hours before RHC
- •prediagnosed glomerulonephritis
- •polycystic kidney disease
- •postrenal obstruction
- •single kidney (functional or anatomical)
- •solid organ transplantation
- •anticipated life expectancy of <12 months
- •likelihood of receiving advanced therapy (mechanical circulatory assist device/lung or cardiac transplant)
- •pregnancy or possibility of pregnancy in the next 12 months
- •inability to cooperate with respiratory maneuvers during renal Doppler
- •refusal to participate
- •not available for follow-up visits
研究组 & 干预措施
Pulmonary hypertension
Patients with diagnosed PH by right heart catheterization with or without PH-specific treatment
干预措施: No intervention is planned as part of the study (Other)
No pulmonary hypertension
Patients in whom PH was excluded by right heart catheterization
干预措施: No intervention is planned as part of the study (Other)
结局指标
主要结局
Major adverse kidney events
时间窗: Baseline to 12 months
Number of patients experiencing ≥q of the individual outcomes of the composite outcome of eGFR decline ≥25%, initiation of dialysis, or kidney-related death
Worsening PH or HF
时间窗: Baseline to 12 months
Number of patients experiencing worsening of PH, defined as hospitalization due to acute right heart failure, increase in PH-targeted medication or diuretics (outpatient or inpatient), or worsening of PH as diagnosed by right heart catheterization
次要结局
- Initiation of dialysis(Baseline to 12 months)
- All-cause mortality(Baseline to 12 months)
- Kidney function decline(12 months)
- Pulmonary hypertension-related death(12 months)