NCT02642081

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

December 17, 2015

Last Update Submit

January 6, 2016

Conditions

Heart Failure

Keywords

NSAIDsHeart failureAcute kidney injury

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Admission for acute decompensated heart failure

    1 month after exposure to NSAIDs

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patients with prescription of NSAIDs

You may qualify if:

  • Patient's age was more than 20 years old
  • Diagnosis of heart failure
  • With prescription of NSAIDs (only oral and intravenous form are included)

You may not qualify if:

  • With prescription of NSAIDs administered by topical use
  • Patient was pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Heart FailureAcute Kidney Injury

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Chii-Ming Lee

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chii-Ming Lee

CONTACT

886-972-651-087chiiminglee@ntu.edu.tw

Po-Lin Chen

CONTACT

886-919-552-322r03451008@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2015

First Posted

December 30, 2015

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

TW(1)