Clinical Trial: Methods and Design
The Singapore Heart Failure Outcomes and Phenotypes (SHOP) Study and Prospective Evaluation of Outcome in Patients With Heart Failure With Preserved Left Ventricular Ejection Fraction (PEOPLE) Study: Rationale and Design

https://doi.org/10.1016/j.cardfail.2013.01.007Get rights and content

Abstract

Background

Heart failure (HF) with preserved ejection fraction (EF) accounts for a substantial proportion of cases of HF, and to date no treatments have clearly improved outcome. There are also little data comparing HF cohorts of differing ethnicity within the Asia-Pacific region.

Methods

The Singapore Heart Failure Outcomes and Phenotypes (SHOP) study and Prospective Evaluation of Outcome in Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction (PEOPLE) study are parallel prospective studies using identical protocols to enroll patients with HF across 6 centers in Singapore and 4 in New Zealand. The objectives are to determine the relative prevalence, characteristics, and outcomes of patients with HF and preserved EF (EF ≥50%) compared with those with HF and reduced EF, and to determine initial data on ethnic differences within and between New Zealand and Singapore. Case subjects (n = 2,500) are patients hospitalized with a primary diagnosis of HF or attending outpatient clinics for management of HF within 6 months of HF decompensation. Control subjects are age- and gender-matched community-based adults without HF from Singapore (n = 1,250) and New Zealand (n = 1,073). All participants undergo detailed clinical assessment, echocardiography, and blood biomarker measurements at baseline, 6 weeks, and 6 months, and are followed over 2 years for death or hospitalization. Substudies include vascular assessment, cardiopulmonary exercise testing, retinal imaging, and cardiac magnetic resonance imaging.

Conclusions

The SHOP and PEOPLE studies are the first prospective multicenter studies defining the epidemiology and interethnic differences among patients with HF in the Asia-Oceanic region, and will provide unique insights into the pathophysiology and outcomes for these patients.

Section snippets

Methods

This is a prospective observational study of representative samples of patients with validated HF in Singapore and New Zealand, compared with age-matched control subjects without HF, designed to address the following aims and hypotheses.

Discussion

HF is a major public health problem worldwide, and is associated with prominent inter-ethnic differences. While HF has traditionally been viewed as occurring in the setting of LV systolic dysfunction, numerous studies have now shown that HF can occur in the setting of preserved LVEF, constituting the syndrome of HF-PEF. This terminology is important, because it describes the commonly used measure of EF but does not infer normal LV systolic function, thus allowing for subtle abnormalities of

Conclusion

HF constitutes a major global public health problem. The SHOP and PEOPLE studies are the first prospective multicenter studies defining the epidemiology and interethnic differences among patients with HF in the Asia-Oceanic region, and they will provide unique insights into the pathophysiology and outcomes for these patients.

Acknowledgments

The authors acknowledge the sonographers, technicians, nurses, and staff of the Cardiovascular Research Institute, National University Heart Centre, Singapore; the Cardiovascular Research Group, University of Auckland (M. ter Bals, M. Copley, M. Fish, G. Wadams, and G. Whalley), and the Heart Failure Service, Auckland District Health Board (H. McGrinder, J. Hannah, M. Mathews, and N. Bos) for their technical and clinical support for this study.

Disclosures

None.

References (41)

  • K.C. Wu et al.

    Late gadolinium enhancement by cardiovascular magnetic resonance heralds an adverse prognosis in nonischemic cardiomyopathy

    J Am Coll Cardiol

    (2008)
  • C.S. Lam et al.

    The mitral annular middiastolic velocity curve: functional correlates and clinical significance in patients with left ventricular hypertrophy

    J Am Soc Echocardiogr

    (2008)
  • C.S. Lam et al.

    The mitral L wave: a marker of pseudonormal filling and predictor of heart failure in patients with left ventricular hypertrophy

    J Am Soc Echocardiogr

    (2005)
  • P.A. Heidenreich et al.

    Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association

    Circulation

    (2011)
  • V.L. Roger et al.

    Trends in heart failure incidence and survival in a community-based population

    JAMA

    (2004)
  • D. Levy et al.

    Long-term trends in the incidence of and survival with heart failure

    N Engl J Med

    (2002)
  • H. Bahrami et al.

    Differences in the incidence of congestive heart failure by ethnicity: the Multi-Ethnic Study of Atherosclerosis

    Arch Intern Med

    (2008)
  • T.P. Ng et al.

    Trends and ethnic differences in hospital admissions and mortality for congestive heart failure in the elderly in Singapore, 1991 to 1998

    Heart

    (2003)
  • R.N. Doughty et al.

    Changing survival of patients with heart failure in New Zealand over 18 years

    Eur Heart J

    (2007)
  • R. Doughty et al.

    Hospital admissions and deaths due to congestive heart failure in New Zealand, 1988–91

    N Z Med J

    (1995)

    • Cited by (0)

    The last 2 authors contributed equally to this work.

    Registration: Australian New Zealand Clinical Trial Registry (ACTRN12610000374066).

    Funding: National Medical Research Council, Singapore (grant no. R-172-003-219-511); A*STAR-NZ HRC (grant no. JGC 10_027); Clinician Scientist Award (C.S.P.L.); NZ Heart Foundation Project Grant, TM Hosking Trust, Auckland; HRC Programme Grant; New Zealand Heart Foundation Chair in Cardiovascular Studies (A.M.R.); New Zealand Heart Foundation Chair in Heart Health (R.N.D.); and Auckland Medical Research Foundation.

    See page 161 for disclosure information.

    View full text
    Copyright © 2013 Elsevier Inc. All rights reserved.