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Volumn 20, Issue 4, 2014, Pages 223-228

Clinical trial design in contemporary device studies in heart failure: Is there a gold standard?

Author keywords

Clinical trials; heart failure; implantable devices

Indexed keywords

PLACEBO;

EID: 84897467828     PISSN: 10719164     EISSN: 15328414     Source Type: Journal    
DOI: 10.1016/j.cardfail.2014.01.009     Document Type: Article
Times cited : (9)

References (15)
  • 1
    • 0027083332 scopus 로고
    • Placebo treatment in congestive heart failure
    • T.P. Archer, and C.V. Leier Placebo treatment in congestive heart failure Cardiology 81 1992 125 133 (Pubitemid 23052123)
    • (1992) Cardiology , vol.81 , Issue.2-3 , pp. 125-133
    • Archer, T.P.1    Leier, C.V.2
  • 2
    • 0000370833 scopus 로고
    • A double-blind study of the treatment of hypertension
    • R.F. Grenfell, A.H. Briggs, and W.C. Holland A double-blind study of the treatment of hypertension JAMA 176 1961 124 128
    • (1961) JAMA , vol.176 , pp. 124-128
    • Grenfell, R.F.1    Briggs, A.H.2    Holland, W.C.3
  • 3
    • 0030463813 scopus 로고    scopus 로고
    • Effect of colour of drugs: Systematic review of perceived effect of drugs and their effectiveness
    • A.J.M. de Craen, P.J. Roos, A.L. de Vries, and J. Kleijnen Effect of colour of drugs: systematic review of perceived effect of drugs and their effectiveness BMJ 313 1996 1624
    • (1996) BMJ , vol.313 , pp. 1624
    • De Craen, A.J.M.1    Roos, P.J.2    De Vries, A.L.3    Kleijnen, J.4
  • 5
    • 79961189578 scopus 로고    scopus 로고
    • Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: Results from the double-blind, randomized, placebo-controlled Rheos Pivotal Trial
    • J.D. Bisognano, G. Bakris, and M.K. Nadim Baroreflex activation therapy lowers blood pressure in patients with resistant hypertension: results from the double-blind, randomized, placebo-controlled Rheos Pivotal Trial J Am Coll Cardiol 58 2011 765 773
    • (2011) J Am Coll Cardiol , vol.58 , pp. 765-773
    • Bisognano, J.D.1    Bakris, G.2    Nadim, M.K.3
  • 7
    • 0037809703 scopus 로고    scopus 로고
    • Pacemaker therapy for prevention of syncope in patients with recurrent severe vasovagal syncope: VPS II
    • S.J. Connolly, R. Sheldon, K.E. Thorpe, R.R. Roberts, K.A. Ellenbogen, and B.L. Wilkoff et al. Pacemaker therapy for prevention of syncope in patients with recurrent severe vasovagal syncope: VPS II JAMA 289 2003 2224 2229
    • (2003) JAMA , vol.289 , pp. 2224-2229
    • Connolly, S.J.1    Sheldon, R.2    Thorpe, K.E.3    Roberts, R.R.4    Ellenbogen, K.A.5    Wilkoff, B.L.6
  • 8
    • 33847721679 scopus 로고    scopus 로고
    • FDA Executive Summary December 7, 2011. Accessed February 10, 2014
    • FDA Executive Summary. Circulatory System Devices Panel Meeting, December 7, 2011. http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ CirculatorySystemDevicesPanel/UCM282274.pdf. Accessed February 10, 2014.
    • Circulatory System Devices Panel Meeting
  • 9
    • 31344442063 scopus 로고    scopus 로고
    • Rationale and design of a randomized controlled trial to assess the safety and efficacy of cardiac resynchronization therapy in patients with asymptomatic left ventricular dysfunction with previous symptoms or mild heart failure - The REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) study
    • DOI 10.1016/j.ahj.2005.03.002, PII S000287030500222X
    • C. Linde, M. Gold, W.T. Abraham, and J.C. Daubert Rationale and design of a randomized controlled trial to assess the safety and efficacy of cardiac resynchronization therapy in patients with asymptomatic left ventricular dysfunction with previous symptoms or mild heart failure - the Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) study Am Heart J 151 2006 288 294 (Pubitemid 43144728)
    • (2006) American Heart Journal , vol.151 , Issue.2 , pp. 288-294
    • Linde, C.1    Gold, M.2    Abraham, W.T.3    Daubert, J.-C.4
  • 11
    • 34547830376 scopus 로고    scopus 로고
    • Measuring the success of blinding in RCTs: Don't, must, can not or needn't?
    • D.L. Sackett Measuring the success of blinding in RCTs: don't, must, can not or needn't? Int J Epidemiol 36 2007 664 665
    • (2007) Int J Epidemiol , vol.36 , pp. 664-665
    • Sackett, D.L.1
  • 12
    • 0021932677 scopus 로고
    • Assessment of double-blindness at the conclusion of the β-blocker heart attack trial
    • DOI 10.1001/jama.253.12.1733
    • R.P. Byington, J.D. Curb, and M.E. Mattson Beta-Blocker Heart Attack Trial Research Group. Assessment of double-blindedness at the conclusion of the Beta-Blocker Heart Attack Trial JAMA 253 1985 1733 1736 (Pubitemid 15136535)
    • (1985) Journal of the American Medical Association , vol.253 , Issue.12 , pp. 1733-1736
    • Byington, R.P.1    Curb, J.D.2    Mattson, M.E.3
  • 14
    • 0141833136 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health (section 5D). Accessed October 2, 2013
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence. http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm070852.htm#5d (section 5D). Accessed October 2, 2013.
    • Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.