- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00400257
Screening Evaluation of the Evolution of New Heart Failure (SCREEN-HF)
SCREEN-HF (Screening Evaluation of the Evolution of New Heart Failure)
연구 개요
상세 설명
Measuring Brain natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP)and can give us useful information about a persons heart function in patients with symptoms such as shortness of breath. This is because BNP/NT-proBNP levels rise when the heart is under pressure as it is in people with heart disease. However, we don't know if this is a useful test to do in people who are at a high risk of developing heart disease but who have no symptoms and have not been diagnosed with any heart problems.
In this study we hope to recruit 3500 participants. This study is being run in conjunction with HBA (recently renamed Bupa) and we estimate that 10,000 HBA members will need to be contacted by letter and invited to screen for this study to achieve the required 3500 (protocol amended to include people who meet the entry criteria but who are not insured through HBA).
This protocol has been amended to allow us to invite 50 participants with the lowest NT-proBNP levels to also continue in the study and have blood tests, an ECG and echocardiography as described below.
Participants will undergo a routine blood test which will include measuring NT-proBNP. Only participants in whom NT-proBNP is elevated will undergo additional blood tests (for cardiac markers), an ECG and echocardiography to determine if there is any indication that they do have heart disease even though they have not been diagnosed and are not symptomatic.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
Victoria
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Melbourne, Victoria, 호주, 3004
- Alfred Hospital
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age ≥60 years
- Have been insured with HBA for 12 months or longer (Protocol amended to remove this criteria and allow enrollment of the general public)
Subjects at high-risk of subsequent development of heart failure; comprising at least one of:
- Prior myocardial infarction (MI) without known left ventricular (LV) dysfunction
- Current active ischemic heart disease
- Prior Cerebrovascular Accident (CVA)
- Known valvular heart disease without known LV dysfunction
- Atrial fibrillation
- Ventricular arrhythmia resulting in syncope or pre-syncope (protocol amended to remove this entry criteria)
- Treated hypertension, of at least 2 years duration
- Treated Diabetes mellitus, of at least 2 years duration
- Estimated Glomerular Filtration Rate (eGFR) <50ml/min
Exclusion Criteria:
- Known systolic or diastolic heart failure
- Symptoms suggestive of current heart failure. (protocol amended to remove this criteria)
- LV systolic or diastolic dysfunction on echocardiography or other objective imaging modality.
- Medications for treatment of heart failure such as ACE inhibitors, angiotensin receptor blockers (ARBs), beta-blockers or aldosterone antagonists. Use of such medications for approved indications such as hypertension, post-MI management (without known LV dysfunction) or for diabetic nephropathy is permitted. (protocol amended to remove this criteria)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
1
People at high risk of heart failure.
|
Early detection of heart failure
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
To assess the effectiveness of BNP in determining Heart Failure in people not previously diagnosed with the condition.
기간: at visit 2
|
at visit 2
|
공동 작업자 및 조사자
스폰서
협력자
간행물 및 유용한 링크
일반 간행물
- Campbell DJ, Coller JM, Gong FF, McGrady M, Boffa U, Shiel L, Liew D, Stewart S, Owen AJ, Krum H, Reid CM, Prior DL. Kidney age - chronological age difference (KCD) score provides an age-adapted measure of kidney function. BMC Nephrol. 2021 Apr 26;22(1):152. doi: 10.1186/s12882-021-02324-y.
- Gong FF, Jelinek MV, Castro JM, Coller JM, McGrady M, Boffa U, Shiel L, Liew D, Wolfe R, Stewart S, Owen AJ, Krum H, Reid CM, Prior DL, Campbell DJ. Risk factors for incident heart failure with preserved or reduced ejection fraction, and valvular heart failure, in a community-based cohort. Open Heart. 2018 Jul 23;5(2):e000782. doi: 10.1136/openhrt-2018-000782. eCollection 2018. Erratum In: Open Heart. 2018 Sep 5;5(2):e000782corr1.
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. .