- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00693745
Neutrophil Gelatinase-Associated Lipcalin (NGAL) Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF (GALLANT)
NGAL Evaluation Along With B-Type Natriuretic Peptide in Acutely Decompensated HF
연구 개요
상태
정황
상세 설명
Approximately 200 adults presenting to the Emergency Department (ED) / hospital with acutely decompensated HF will be enrolled. EDTA anti-coagulated blood samples will be collected for measurement of blood NGAL levels (using the Triage NGAL Test) at the point of care in all subjects at up to 8 different time points from presentation until discharge.
The results of these NGAL assessments will be blinded to the medical team during the study and will not impact the medical management of the subject.
Blood samples for unblinded assessment of both serum creatinine (analyzed at the hospital's laboratory) and whole blood BNP (analyzed with the Triage BNP Test at the point-of-care or laboratory) will also be obtained at some of the same time points.
Dialysis, emergent outpatient visits for HF, hospitalizations and mortality will be recorded through Day 30 and Day 90. If an additional serum creatinine has been obtained as standard care near Day 30, it will also be recorded.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Groningen, 네덜란드, 9700 RB
- UMC Groningen (UMCG)
-
-
-
-
California
-
San Diego, California, 미국, 92161
- San Diego Veterans Affairs Hospital
-
-
New York
-
Brooklyn, New York, 미국, 11215
- New York Methodist Hospital
-
-
Ohio
-
Columbus, Ohio, 미국, 43210
- Ohio State University
-
-
-
-
-
Basel, 스위스, 4031
- University Hospital - Basel
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Males and females 18 years of age or older;
- Patients presenting to the emergency department / hospital with symptoms of new or decompensated heart failure and who will be treated with at least one dose of IV diuretic;
- Ability to draw blood samples for baseline NGAL, BNP and creatinine levels either prior to the administration of the first dose of IV diuretic or within 1 hour after the first dose of an IV diuretic
- Ability to provide written informed consent from subject or their authorized representative.
Exclusion Criteria:
- Acute myocardial infarction or active ischemia;
- Patients who are intubated or otherwise not able to communicate or comply with study assessments;
- Cardiogenic shock or any other clinical condition that would contraindicate the administration of an IV agent with potent vasodilating properties;
- Known history of marked renal insufficiency (e.g., usual serum creatinine ≥ 3.0 mg/dL), on dialysis (either acute of chronic) or in imminent need of dialysis at enrollment;
- Prisoners or other institutionalized or vulnerable individuals;
- Participation in an interventional clinical study within the previous 30 days;
- Unlikely to be willing or able to comply with study procedures, including the follow-up at 30 and 90 days .
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Alan Maisel, MD, UCSD, San Diego VA Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .