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临床试验/NCT06671314
NCT06671314已完成不适用

Adoption of Novel Heart Failure Therapy and Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction

Novartis1 个研究点 分布在 1 个国家目标入组 42,494 人开始时间: 2022年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Novartis
入组人数
42,494
试验地点
1
主要终点
Time Spent 30 Days Post-discharge by Discharge Sacubitril/Valsartan (SAC/VAL) Prescription Status

研究概览

简要总结

This was a retrospective observational cohort study using patient data from the Get With The Guideline-Heart Failure (GWTG-HF) registry linked to Medicare Fee-for-Service (FFS) claims. The main goal of the study was to compare home-time in Medicare FFS patients with heart failure with mildly reduced or preserved ejection fraction discharged with sacubitril/valsartan versus those discharged without sacubitril/valsartan.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Time Spent 30 Days Post-discharge by Discharge Sacubitril/Valsartan (SAC/VAL) Prescription Status

时间窗: Post-discharge at Day 30

Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

Time Spent 90 Days Post-discharge by Discharge SAC/VAL Prescription Status

时间窗: Post-discharge at Day 90

Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

Time Spent 180 Days Post-discharge by Discharge SAC/VAL Prescription Status

时间窗: Post-discharge at Day 180

Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

Time Spent 365 Days Post-discharge by Discharge SAC/VAL Prescription Status

时间窗: Post-discharge at Day 365

Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.

次要结局

  • Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge With a Sacubitril/Valsartan (SAC/VAL) Prescription(Post-discharge at Days 30, 90, 180, and 365)
  • Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
  • Number of All-cause Mortality or Heart Failure (HF) Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
  • Number of All-cause Mortality or HF Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
  • Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
  • Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
  • Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
  • Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
  • Number Patients Hospitalized for Dialysis or End-Stage Kidney Disease at 365 Days After Discharge With and Without a SAC/VAL Prescription(Post-discharge at Day 365)
  • Number Patients Hospitalized for a Metabolic/Nutritional Disorder at 365 Days After Discharge With and Without a SAC/VAL Prescription(Post-discharge at Day 365)
  • Number Patients Hospitalized for Urinary Tract Infection at 365 Days After Discharge With and Without a SAC/VAL Prescription(Post-discharge at Day 365)
  • Number Patients Hospitalized for a Hip Fracture at 365 Days After Discharge With and Without a SAC/VAL Prescription(Post-discharge at Day 365)
  • Difference in Days of Home-time Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
  • Difference in All-cause Mortality Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
  • Difference in Composite Measure Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
  • Difference in All-cause Re-hospitalization Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
  • Difference in HF Re-hospitalization Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Days 30, 90, 180, and 365)
  • Difference in Hospitalization for Metabolic/Nutritional Disorder Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Day 365)
  • Difference in Hospitalization for Urinary Tract Infection Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Day 365)
  • Difference in Hospitalization for Hip Fracture Between Discharge With and Without SAC/VAL Prescription(Post-discharge at Day 365)
  • Number of All-cause Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status(Post-discharge at Day 365)
  • Number of HF Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status(Post-discharge at Day 365)
  • All-cause Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status(Post-discharge at Day 365)
  • All-cause HF-related Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status(Post-discharge at Day 365)

研究者

发起方
Novartis
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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