Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Risk of Acute Kidney Injury in Patients With Heart Failure

Heart Failure Clinical Trial

Official title:

Non-steroidal Anti-inflammatory Drugs (NSAIDs) and Risk of Acute Kidney Injury in Patients With Heart Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02642081
• Other study ID #: 201511075RIND
• Status: Not yet recruiting
• Phase: N/A
• First received: December 17, 2015
• Last updated: January 6, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: National Taiwan University Hospital
• Contact: Chii-Ming Lee
• Phone: 886-972-651-087
• Email: chiiminglee[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate whether non-steroidal anti-inflammatory drugs (NSAIDs) were associated with acute kidney injury (AKI) in patients with heart failure. In addition, the investigators would like to assess the risk of admission for acute decompensated heart failure following exposure to NSAIDs within 30 days.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion criteria

1. Patient's age was more than 20 years old

2. Diagnosis of heart failure

3. With prescription of NSAIDs (only oral and intravenous form are included)

Exclusion criteria

1. With prescription of NSAIDs administered by topical use

2. Patient was pregnant

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Heart Failure

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in serum creatinine at 1 month	We collect not only patient's baseline serum creatinine level (defined as the median value of the previous-six-months serum creatinine), but also serum creatinine level on the detecting day (defined as the most recent day from index date we detecting the serum creatinine). Acute kidney injury is defined as the absolute increase in the serum creatinine concentration of =0.3 mg/dL from baseline; or a percentage increase in the serum creatinine concentration of =50 percent.	Baseline and 1 month	Yes
Secondary	Admission for acute decompensated heart failure		1 month after exposure to NSAIDs	Yes