- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01962688
Handheld Ultrasound Evaluation of the Inferior Vena Cava to Guide Heart Failure Treatment
A Randomized Study of Pocket Ultrasound Derived IVC Diameter for Guided Management of Heart Failure
연구 개요
상세 설명
The purpose of this research study is to investigate the use of pocket ultrasound device, called Vscan, in guiding diuretic therapy in ambulatory and inpatient Congestive Heart Failure (CHF) patients. Specifically, Vscan will be used to monitor Inferior Vena Cava (IVC) diameters with the goal of reaching a 50% reduction in IVC when compared to baseline measurements. We hypothesize that compared to the conventional clinical assessment Guided Diuretic Therapy, this new proposed Vscan guided therapy will result in reduction in hospitalization rates. This study is composed of two independent non-interacting randomized single blinded trials-one in the outpatient setting and one in the inpatient setting. 138 total patients and 300 patients will be recruited to the ambulatory trial and inpatient trial respectively.
- Objectives The objective of the study is to determine whether a simple one step protocol of increasing diuretics to guide a 50% reduction of IVC diameter from baseline measurements results in reduction in hospitalization rates as compared to those seen in therapy determined on the basis of conventional clinical evaluation by a CHF specialist.
- Background Congestive heart failure (CHF) remains a leading cause of death in industrialized countries. Despite advances in medical treatment, an estimated 250,000-300,000 CHF patients are hospitalized in the United States each year for symptoms caused by low cardiac output (CO). Although the events that cause acute decompensation are multifactorial, the common pathway associated with decreased ventricular function are autonomic dysfunction and fluid retention. It has been previously suggested that an estimated 50%-66% of CHF hospitalizations may be preventable with improved monitoring of fluid volume status. The size and shape of the inferior vena cava (IVC) is correlated to the central venous pressure and circulating blood volume. Therefore evaluation of the IVC provides an instantaneous non-invasive measure of volume status.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10029
- Icahn School of Medicine at Mount Sinai
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with a diagnosis of congestive heart failure
- NYHA class II-IV (ambulatory only)
- left ventricular systolic dysfunction with ejection fraction (EF) < 50%
- history of hospitalization for heart failure within the last year (ambulatory only)
- age >18 years old
- admission to heart failure service (inpatient arm only)
Exclusion Criteria:
- Patients with dyspnea not mainly due to heart failure
- valvular disease requiring surgery
- acute coronary syndromes within the previous 10 days
- revascularization within the previous month
- body mass index higher than 35
- serum creatinine level higher than 2.49 mg/dL
- a life expectancy of less than 3 years from noncardiovascular diseases (ambulatory arm only)
- a life expectancy of less than 1 year from noncardiovascular disease (inpatient arm only)
- non-cardiovascular causes of acute renal failure present on admission that preclude the use of diuretics (inpatient arm only)
- unable to give informed consent
- no follow-up possible
- participating in another study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Handheld ultrasound - inpatient
Handheld Ultrasound IVC Diameter Guided Diuretic Therapy Handheld ultrasound of the IVC diameter is used to guide diuretic therapy
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Handheld ultrasound determination of IVC diameter
다른 이름들:
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가짜 비교기: Sham ultrasound - inpatient
Conventional Symptom Guided Diuretic Therapy conventional clinical care as would occur outside of the study.
These patients receive a sham ultrasound to facilitate blinding
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sham ultrasound to facilitate blinding
다른 이름들:
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실험적: Handheld ultrasound - ambulatory
Handheld Ultrasound IVC Diameter Guided Diuretic Therapy Handheld ultrasound of the IVC diameter is used to guide diuretic therapy in the ambulatory setting during normal clinic visits.
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Handheld ultrasound determination of IVC diameter
다른 이름들:
|
가짜 비교기: Sham ultrasound - ambulatory
Conventional Symptom Guided Diuretic Therapy conventional clinical care as would occur outside of the study.
These patients receive a sham ultrasound to facilitate blinding in the ambulatory setting during normal clinic visits.
|
sham ultrasound to facilitate blinding
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Participants Hospitalized for Cardiovascular Reasons
기간: up to 6 months
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hospitalization information will be recorded throughout the length of the study for the outpatient arms
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up to 6 months
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Number of Participants Hospitalized for Non-cardiac Reasons
기간: up to 6 months
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hospitalization information will be recorded throughout the length of the study for the inpatient arms
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up to 6 months
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Diuretic Change Post-visit
기간: 6 months followup
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Differences in Changes made in Diuretic doses after Heart failure related visit
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6 months followup
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Number of Participants in Each New York Heart Association Class
기간: 6 months
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New York Heart Association (NYHA) Classification Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. |
6 months
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Change in Health Related Quality of Life
기간: 1 month and 6 months
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Change in Health related quality of life at 6 months as compared to at 1 month
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1 month and 6 months
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Length of Stay
기간: up to 6 months
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length of stay in the hospital for inpatient arms only
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up to 6 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jagat Narula, MD, PhD, Icahn School of Medicine at Mount Sinai
간행물 및 유용한 링크
일반 간행물
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- Solomon SD, Dobson J, Pocock S, Skali H, McMurray JJ, Granger CB, Yusuf S, Swedberg K, Young JB, Michelson EL, Pfeffer MA; Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) Investigators. Influence of nonfatal hospitalization for heart failure on subsequent mortality in patients with chronic heart failure. Circulation. 2007 Sep 25;116(13):1482-7. doi: 10.1161/CIRCULATIONAHA.107.696906. Epub 2007 Aug 27.
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- Nagueh SF, Kopelen HA, Zoghbi WA. Relation of mean right atrial pressure to echocardiographic and Doppler parameters of right atrial and right ventricular function. Circulation. 1996 Mar 15;93(6):1160-9. doi: 10.1161/01.cir.93.6.1160.
- Januzzi JL Jr, Camargo CA, Anwaruddin S, Baggish AL, Chen AA, Krauser DG, Tung R, Cameron R, Nagurney JT, Chae CU, Lloyd-Jones DM, Brown DF, Foran-Melanson S, Sluss PM, Lee-Lewandrowski E, Lewandrowski KB. The N-terminal Pro-BNP investigation of dyspnea in the emergency department (PRIDE) study. Am J Cardiol. 2005 Apr 15;95(8):948-54. doi: 10.1016/j.amjcard.2004.12.032.
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- Blehar DJ, Dickman E, Gaspari R. Identification of congestive heart failure via respiratory variation of inferior vena cava diameter. Am J Emerg Med. 2009 Jan;27(1):71-75. doi: 10.1016/j.ajem.2008.01.002.
- McCullough PA, Nowak RM, McCord J, Hollander JE, Herrmann HC, Steg PG, Duc P, Westheim A, Omland T, Knudsen CW, Storrow AB, Abraham WT, Lamba S, Wu AH, Perez A, Clopton P, Krishnaswamy P, Kazanegra R, Maisel AS. B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure: analysis from Breathing Not Properly (BNP) Multinational Study. Circulation. 2002 Jul 23;106(4):416-22. doi: 10.1161/01.cir.0000025242.79963.4c.
- Wang CS, FitzGerald JM, Schulzer M, Mak E, Ayas NT. Does this dyspneic patient in the emergency department have congestive heart failure? JAMA. 2005 Oct 19;294(15):1944-56. doi: 10.1001/jama.294.15.1944.
- Kircher BJ, Himelman RB, Schiller NB. Noninvasive estimation of right atrial pressure from the inspiratory collapse of the inferior vena cava. Am J Cardiol. 1990 Aug 15;66(4):493-6. doi: 10.1016/0002-9149(90)90711-9.
- Moreno FL, Hagan AD, Holmen JR, Pryor TA, Strickland RD, Castle CH. Evaluation of size and dynamics of the inferior vena cava as an index of right-sided cardiac function. Am J Cardiol. 1984 Feb 1;53(4):579-85. doi: 10.1016/0002-9149(84)90034-1.
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- Lucas C, Johnson W, Hamilton MA, Fonarow GC, Woo MA, Flavell CM, Creaser JA, Stevenson LW. Freedom from congestion predicts good survival despite previous class IV symptoms of heart failure. Am Heart J. 2000 Dec;140(6):840-7. doi: 10.1067/mhj.2000.110933.
- Goonewardena SN, Blair JE, Manuchehry A, Brennan JM, Keller M, Reeves R, Price A, Spencer KT, Puthumana J, Gheorghiade M. Use of hand carried ultrasound, B-type natriuretic peptide, and clinical assessment in identifying abnormal left ventricular filling pressures in patients referred for right heart catheterization. J Card Fail. 2010 Jan;16(1):69-75. doi: 10.1016/j.cardfail.2009.08.004. Epub 2009 Sep 26.
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- Guiotto G, Masarone M, Paladino F, Ruggiero E, Scott S, Verde S, Schiraldi F. Inferior vena cava collapsibility to guide fluid removal in slow continuous ultrafiltration: a pilot study. Intensive Care Med. 2010 Apr;36(4):692-6. doi: 10.1007/s00134-009-1745-4. Epub 2010 Jan 22.
- Gackowski A, Isnard R, Golmard JL, Pousset F, Carayon A, Montalescot G, Hulot JS, Thomas D, Piwowarska W, Komajda M. Comparison of echocardiography and plasma B-type natriuretic peptide for monitoring the response to treatment in acute heart failure. Eur Heart J. 2004 Oct;25(20):1788-96. doi: 10.1016/j.ehj.2004.07.038.
- Miller JB, Sen A, Strote SR, Hegg AJ, Farris S, Brackney A, Amponsah D, Mossallam U. Inferior vena cava assessment in the bedside diagnosis of acute heart failure. Am J Emerg Med. 2012 Jun;30(5):778-83. doi: 10.1016/j.ajem.2011.04.008. Epub 2011 Jun 12.
- Brennan JM, Blair JE, Goonewardena S, Ronan A, Shah D, Vasaiwala S, Kirkpatrick JN, Spencer KT. Reappraisal of the use of inferior vena cava for estimating right atrial pressure. J Am Soc Echocardiogr. 2007 Jul;20(7):857-61. doi: 10.1016/j.echo.2007.01.005.
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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 (실제)
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. .
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IRCCS San Raffaele모병
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Academisch Medisch Centrum - Universiteit van Amsterdam...완전한
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Piazza della Vittoria 14 Studio Medico - Ginecologia...모병
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Ajou University School of Medicine종료됨