Heart FailureNCT02877914
China PEACE 5r-HF Study
An observational study of Heart Failure, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
This study will use a two-stage random sampling design to create a nationally representative sample of patients with heart failure (HF) in China. The investigators sought to describe the clinical profiles, to assess treatment patterns and in-hospital outcomes for HF, and to identify targets for care quality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Observational study
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with primary reason for admission of heart failure, aged 18 years or above
Who may be able to join
- Patients with heart failure as the primary reason for hospitalization, including both new-onset HF or decompensation of chronic HF。
- Hospitalized during January 1st, 2015 to December 31st, 2015
- Aged 18 years or above
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhengzhou People's Hospital
Zhengzhou
Hengliang Liu
Hengliang Liu
About this study
Official title: China Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Retrospective Study of Patients With Heart Failure (HF)
This study will use a two-stage random sampling design to create a nationally representative sample of patients with heart failure (HF) in China. The investigators sought to describe the clinical profiles, to assess treatment patterns and in-hospital outcomes for HF, and to identify targets for care quality improvement.
Read the detailed description
This study will use a two-stage random sampling design to create a nationally representative sample in China, and randomly sample patients with HF as a primary diagnosis, and were admitted to hospital from January 1st, 2015 to December 31st, 2015. The sample size is estimated to be 10,000.
The investigators will collect photocopies of the sampled medical records and centrally abstract detailed information, which included demographic characteristics, medical history, clinical features, diagnostic tests, in-hospital procedures, lab tests, treatments, and in-hospital outcomes. Data abstraction quality was monitored by random auditing of 5% of the medical records, with overall variable accuracy exceeding 98%.
Analyses will examine patient characteristics, diagnostic testing patterns, in-hospital treatments, in-hospital outcomes, and variation in results across regions and hospitals. Practical guidelines, quality evaluative system, and risk model will be established based on the findings, to improve patient outcomes for HF in the future.
- Conditions
- Heart Failure
- Being tested
- Observational study
- Keywords
- heart failure, retrospective
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
This is a non-interventional study, patients receive their usual treatment as determined by the physician.
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: Duration of hospitalization, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Center for Cardiovascular Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jing Li, MD, PhD, Principal investigator, China National Center for Cardiovascular DiseaseHarlan M Krumholz, MD, SM, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877914
- Sponsor's protocol ID
- 2015BAI12B02-1
- Status last verified
- Dec 2017
- First submitted
- 16 Aug 2016
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Yu Y, Guan W, Masoudi FA, Wang B, He G, Spertus JA, Lu Y, Krumholz HM, Li J. Hospital Variation of Spironolactone Use in Patients Hospitalized for Heart Failure in China-The China PEACE Retrospective Heart Failure Study. J Am Heart Assoc. 2022 Oct 4;11(19):e026300. doi: 10.1161/JAHA.122.026300. Epub 2022 Sep 29.
PubMed 36172964Yu Y, Gupta A, Wu C, Masoudi FA, Du X, Zhang J, Krumholz HM, Li J; China PEACE Collaborative Group. Characteristics, Management, and Outcomes of Patients Hospitalized for Heart Failure in China: The China PEACE Retrospective Heart Failure Study. J Am Heart Assoc. 2019 Sep 3;8(17):e012884. doi: 10.1161/JAHA.119.012884. Epub 2019 Aug 21.
PubMed 31431117Yu Y, Spatz ES, Tan Q, Liu S, Lu Y, Masoudi FA, Schulz WL, Krumholz HM, Li J; China PEACE Collaborative Group. Traditional Chinese Medicine Use in the Treatment of Acute Heart Failure in Western Medicine Hospitals in China: Analysis From the China PEACE Retrospective Heart Failure Study. J Am Heart Assoc. 2019 Aug 6;8(15):e012776. doi: 10.1161/JAHA.119.012776. Epub 2019 Jul 31.
PubMed 31364457Yu Y, Zhang H, Li X, Lu Y, Masoudi FA, Krumholz HM, Li J. The China Patient-centered Evaluative Assessment of Cardiac Events (China PEACE) retrospective heart failure study design. BMJ Open. 2018 May 10;8(5):e020918. doi: 10.1136/bmjopen-2017-020918.
PubMed 29748344
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Patient-centered Evaluative Assessment of Cardiac Events (PEACE): Retrospective Study of Patients With Heart Failure (HF)
- ClinicalTrials.gov ID
- NCT02877914
- Acronym / sponsor ID
- 2015BAI12B02-1
- Conditions
- Heart Failure
- Keywords
- heart failure, retrospective
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- Sep 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use a two-stage random sampling design to create a nationally representative sample of patients with heart failure (HF) in China. The investigators sought to describe the clinical profiles, to assess treatment patterns and in-hospital outcomes for HF, and to identify targets for care quality improvement.
Detailed description
This study will use a two-stage random sampling design to create a nationally representative sample in China, and randomly sample patients with HF as a primary diagnosis, and were admitted to hospital from January 1st, 2015 to December 31st, 2015. The sample size is estimated to be 10,000.
The investigators will collect photocopies of the sampled medical records and centrally abstract detailed information, which included demographic characteristics, medical history, clinical features, diagnostic tests, in-hospital procedures, lab tests, treatments, and in-hospital outcomes. Data abstraction quality was monitored by random auditing of 5% of the medical records, with overall variable accuracy exceeding 98%.
Analyses will examine patient characteristics, diagnostic testing patterns, in-hospital treatments, in-hospital outcomes, and variation in results across regions and hospitals. Practical guidelines, quality evaluative system, and risk model will be established based on the findings, to improve patient outcomes for HF in the future.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with primary reason for admission of heart failure, aged 18 years or above
Key inclusion criteria (3 listed)
- Patients with heart failure as the primary reason for hospitalization, including both new-onset HF or decompensation of chronic HF。
- Hospitalized during January 1st, 2015 to December 31st, 2015
- Aged 18 years or above
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyThis is a non-interventional study, patients receive their usual treatment as determined by the physician. | Other | – |
Primary outcome
Death
Time frame: Duration of hospitalization, an average of 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Derived from this study: PubMed 36172964Yu Y, Guan W, Masoudi FA, Wang B, He G, Spertus JA, Lu Y, Krumholz HM, Li J. Hospital Variation of Spironolactone Use in Patients Hospitalized for Heart Failure in China-The China PEACE Retrospective Heart Failure Study. J Am Heart Assoc. 2022 Oct 4;11(19):e026300. doi: 10.1161/JAHA.122.026300. Epub 2022 Sep 29.
- Derived from this study: PubMed 31431117Yu Y, Gupta A, Wu C, Masoudi FA, Du X, Zhang J, Krumholz HM, Li J; China PEACE Collaborative Group. Characteristics, Management, and Outcomes of Patients Hospitalized for Heart Failure in China: The China PEACE Retrospective Heart Failure Study. J Am Heart Assoc. 2019 Sep 3;8(17):e012884. doi: 10.1161/JAHA.119.012884. Epub 2019 Aug 21.
- Derived from this study: PubMed 31364457Yu Y, Spatz ES, Tan Q, Liu S, Lu Y, Masoudi FA, Schulz WL, Krumholz HM, Li J; China PEACE Collaborative Group. Traditional Chinese Medicine Use in the Treatment of Acute Heart Failure in Western Medicine Hospitals in China: Analysis From the China PEACE Retrospective Heart Failure Study. J Am Heart Assoc. 2019 Aug 6;8(15):e012776. doi: 10.1161/JAHA.119.012776. Epub 2019 Jul 31.
- Derived from this study: PubMed 29748344Yu Y, Zhang H, Li X, Lu Y, Masoudi FA, Krumholz HM, Li J. The China Patient-centered Evaluative Assessment of Cardiac Events (China PEACE) retrospective heart failure study design. BMJ Open. 2018 May 10;8(5):e020918. doi: 10.1136/bmjopen-2017-020918.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Li, MD, PhD principal investigator
China National Center for Cardiovascular Disease
Harlan M Krumholz, MD, SM principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Li, MD, PhD (+86 (10) 6086 6077, jing.li@fwoxford.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Duration of hospitalization, an average of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02877914, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.