Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000374066
Ethics application status
Approved
Date submitted
4/05/2010
Date registered
10/05/2010
Date last updated
9/02/2021
Date data sharing statement initially provided
9/02/2021
Date results information initially provided
9/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective Evaluation of Outcome for Patients with Heart Failure with Preserved Left Ventricular Ejection Fraction
Scientific title
Prospective evaluation of all cause mortality and clinical outcome for patients with heart failure with preserved left ventricular ejection fraction.
Secondary ID [1] 251677 0
Nil
Universal Trial Number (UTN)
U1111-1114-8716
Trial acronym
PEOPLE

The study will also be known as the SHOP study in Singapore - Singapore Heart Failure Outcomes and Phenotypes Study.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure (HF) 257280 0
Condition category
Condition code
Cardiovascular 257427 257427 0 0
Other cardiovascular diseases
Cardiovascular 257476 257476 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Condition observed: Heart Failure
Baseline visit, then follow up visits will be undertaken at 6 weeks and 6 months - clinical, quality of life, echocardiography (6 months only) and neurohormonal status will be determined. Clinical events will be followed for 2 years.

This is an observational study and does not involve interventions.
Intervention code [1] 256400 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258348 0
Primary outcome: All cause mortality.

This will be measured by follow-up visits at 6 weeks and 6 months, linkage to medical records and telephone followup at 1 and 2 years.
Timepoint [1] 258348 0
Timepoint: Two years after baseline assessment
Secondary outcome [1] 264077 0
Combined endpoint of all cause mortality and HF readmission.

This will be measured by follow-up visits at 6 weeks and 6 months, linkage to medical records and telephone followup at 1 and 2 years.
Timepoint [1] 264077 0
Two years after baseline assessment
Secondary outcome [2] 264078 0
All cause hospital admission.

This will be measured by follow-up visits at 6 weeks and 6 months, linkage to medical records and telephone followup at 1 and 2 years.
Timepoint [2] 264078 0
Two years after baseline assessment
Secondary outcome [3] 264079 0
Heart failure readmission.

This will be measured by follow-up visits at 6 weeks and 6 months, linkage to medical records and telephone followup at 1 and 2 years.
Timepoint [3] 264079 0
Two years after baseline assessment
Secondary outcome [4] 264080 0
Days alive and out of hospital.

This will be measured by follow-up visits at 6 weeks and 6 months, linkage to medical records and telephone followup at 1 and 2 years.
Timepoint [4] 264080 0
Two years after baseline assessment
Secondary outcome [5] 264097 0
Rates of hospital readmission.

This will be measured by follow-up visits at 6 weeks and 6 months, linkage to medical records and telephone followup at 1 and 2 years.
Timepoint [5] 264097 0
Two years after baseline assessment

Eligibility
Key inclusion criteria
Patients who either:

a) Present to hospital with a primary diagnosis of heart failure, or

b) Attend a hospital clinic for management of HF within 6 months of diagnosis
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from this study if:

a) HF is primarily due to valve disease

b) if the primary diagnosis is an acute coronary syndrome which has resulted in a transient episode of acute pulmonary oedema. (Note: patients with a troponin rise noted during the index admission, but in whom the main presentation is considered clinically to be HF will be included).

c) the patient has end stage renal failure estimated glomerular filtration rate (eGFR)<15ml/min/m2 or is receiving or planned to receive renal replacement therapy

d) constrictive pericarditis

e) other life threatening comorbidity with a life expectancy of <1 year

f) inability to provide informed consent

g) inability to comply with study protocol requirements

Patients who are unable to attend for follow-up will still be considered for the study even if they are not able to undertake the post discharge study visits.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
20/04/2010
Actual
20/04/2010
Date of last participant enrolment
Anticipated
Actual
31/08/2014
Date of last data collection
Anticipated
6/03/2017
Actual
6/03/2017
Sample size
Target
2500
Accrual to date
Final
2039
Recruitment outside Australia
Country [1] 2597 0
Singapore
State/province [1] 2597 0
Singapore
Country [2] 2598 0
New Zealand
State/province [2] 2598 0
Auckland
Country [3] 2599 0
New Zealand
State/province [3] 2599 0
Hamilton
Country [4] 2600 0
New Zealand
State/province [4] 2600 0
Christchurch

Funding & Sponsors
Funding source category [1] 256902 0
Government body
Name [1] 256902 0
Health Research Council of New Zealand
Country [1] 256902 0
New Zealand
Funding source category [2] 256903 0
Government body
Name [2] 256903 0
Agency for Science, Technology and Research of Singapore (A*STAR)
Country [2] 256903 0
Singapore
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Victoria Street West
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 256174 0
None
Name [1] 256174 0
Address [1] 256174 0
Country [1] 256174 0
Other collaborator category [1] 1230 0
Individual
Name [1] 1230 0
Dr Gerry Devlin
Address [1] 1230 0
Waikato Hospital
Pembroke Street
Hamilton 3204
New Zealand
Country [1] 1230 0
New Zealand
Other collaborator category [2] 1231 0
Individual
Name [2] 1231 0
Professor Mark Richards
Address [2] 1231 0
Christchurch Hospital
2 Riccarton Avenue
Addington 8011
Christchurch
New Zealand
Country [2] 1231 0
New Zealand
Other collaborator category [3] 1232 0
Individual
Name [3] 1232 0
Dr Mayanna Lund
Address [3] 1232 0
Middlemore Hospital
100 Hospital Road
Papatoetoe
Auckland 2025
New Zealand
Country [3] 1232 0
New Zealand
Other collaborator category [4] 1233 0
Individual
Name [4] 1233 0
Dr Carolyn Lam
Address [4] 1233 0
National University Hospital of Singapore
5 Lower Kent Ridge Road
Singapore 119074
Country [4] 1233 0
Singapore
Other collaborator category [5] 1234 0
Individual
Name [5] 1234 0
David Sim
Address [5] 1234 0
National Heart Centre Singapore
17 Third Hospital Avenue
Mistri Wing
Singapore 168752
Country [5] 1234 0
Singapore
Other collaborator category [6] 1235 0
Individual
Name [6] 1235 0
Soondal Koomar Surrun
Address [6] 1235 0
Singapore General Hospital
Hospital Drive
Singapore 169608
Country [6] 1235 0
Singapore
Other collaborator category [7] 1237 0
Individual
Name [7] 1237 0
Ong Heon Yee
Address [7] 1237 0
Khoo Teck Puat Hospital
378 Alexandra Road
Singapore 159964
Country [7] 1237 0
Singapore
Other collaborator category [8] 1238 0
Individual
Name [8] 1238 0
Gerard Leong
Address [8] 1238 0
Changi General Hospital
2 Simei Street 3
Singapore 529889
Country [8] 1238 0
Singapore
Other collaborator category [9] 1240 0
Individual
Name [9] 1240 0
Daniel Yeo
Address [9] 1240 0
Tan Tock Seng Hospital
11 Jalan Tan Tock Seng
Singapore 308433
Country [9] 1240 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258911 0
Multi-region Ethics Committee
Ethics committee address [1] 258911 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6145
Ethics committee country [1] 258911 0
New Zealand
Date submitted for ethics approval [1] 258911 0
Approval date [1] 258911 0
26/01/2010
Ethics approval number [1] 258911 0
MEC/09/11/124
Ethics committee name [2] 258912 0
National Health Group Domain Specific Review Board (DSRB) Singapore
Ethics committee address [2] 258912 0
6 Commonwealth Lane
Level 6
GMTI Building
Singapore 149547
Ethics committee country [2] 258912 0
Singapore
Date submitted for ethics approval [2] 258912 0
Approval date [2] 258912 0
01/04/2010
Ethics approval number [2] 258912 0

Summary
Brief summary
PEOPLE/SHOP is a prospective, longitudinal, multicentre cohort study conducted at 4 sites in New Zealand and 5 sites in Singapore. The aims are to:
1. To determine proportion of patients with heart failure who have Heart Failure-Preserved Ejection Fraction (HF-PEF) according to newly proposed European Society of Cardiology criteria.
2. To determine clinical outcome for patients with HF-PEF with patients with heart failure with low ejection fraction (HF-lowEF).
3. To determine clinical, echocardiographic and neurohormonal characteristics and predictors of outcome in HF-PEF compared to HF-lowEF.

Subjects will be those patients with heart failure who are either admitted to hospital or seen in an out-patient clinic with a primary diagnosis of heart failure. Clinical characteristics, echocardiographic and neurohormonal status will be documented at the time of enrolment. Follow up visits will be undertaken at 6 weeks and 6 months, when clinical, quality of life, echocardiographic (6 months only) and neurohormonal status will be determined. Clinical events will be followed for 2 years.
Trial website
N/A
Trial related presentations / publications

Carolyn S.P. Lam, Greg D. Gamble, Lieng H. Ling, David Sim,
Kui Toh Gerard Leong, Poh Shuan Daniel Yeo, Hean Yee Ong, Fazlur Jaufeerally,
Tze P. Ng, Vicky A. Cameron, Katrina Poppe, Mayanna Lund, Gerry Devlin,
Richard Troughton, A. Mark Richards, and Robert N. Doughty. Mortality associated with heart failure with preserved vs. reduced ejection fraction in a prospective international multi-ethnic cohort study. European Heart Journal (2018). doi:10.1093/eurheartj/ehy005
Public notes

Contacts
Principal investigator
Name 31083 0
Prof Rob N. Doughty
Address 31083 0
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 31083 0
New Zealand
Phone 31083 0
+642785623
Fax 31083 0
Email 31083 0
[email protected]
Contact person for public queries
Name 14330 0
Mrs Gina Wadams
Address 14330 0
Cardiovascular Research Group
Dept of Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Victoria Street West
Auckland 1142
New Zealand
Country 14330 0
New Zealand
Phone 14330 0
+64 9 923 9812
Fax 14330 0
+64 9 367 7146
Email 14330 0
[email protected]
Contact person for scientific queries
Name 5258 0
Associate Professor Rob Doughty MD FRCP FRACP FCSANZ
Address 5258 0
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country 5258 0
New Zealand
Phone 5258 0
+64 9 923 9804
Fax 5258 0
+64 9 367 7146
Email 5258 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAtrial Fibrillation and the Prognostic Performance of Biomarkers in Heart Failure.2021https://dx.doi.org/10.1093/clinchem/hvaa287
EmbaseEthnic differences in atrial fibrillation in patients with heart failure from Asia-Pacific.2019https://dx.doi.org/10.1136/heartjnl-2018-314077
EmbaseMyeloperoxidase Inhibition Reverses Biomarker Profiles Associated With Clinical Outcomes in HFpEF.2023https://dx.doi.org/10.1016/j.jchf.2023.03.002
N.B. These documents automatically identified may not have been verified by the study sponsor.