Heart FailureNCT06099028
Heart Failure Treatment Pattern Analysis of HF Patients in HF Centers and Non-HF Centers in China
An observational study of Heart Failure, run by Peking University First Hospital at 1 site in China.
Trial summary
This is a retrospective, researcher-initiated, database-based study that will retrospectively observe the treatment and medication patterns of about 22,500 patients with heart failure from 25 heart failure centers and 25 non-heart failure centers in the database of heart failure center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 22,500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Mar 2023
- 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: The study population will include HF patients extracted from the HF centers Database. The enrolment of HF cases was via the consecutive sampling. In this study, the study time frame is from 2021.09 to 2023.03. The index date will be defined as the discharge date after the first HF admission (inpatient) record shown in the database, (i.e., the discharge date is the date entry into the HF centers Database). Given that previous treatment condition of these patients before the enrolment in this database is unknown, the baseline information was only collected at the index date. Patient follow-ups were scheduled at 1 month, 3 months and 12 months after the first discharge. The window of follow-up was set for ±14 days.
Who may be able to join
- An index HF diagnosis date in the records
- Age ≥ 18 years old at initial diagnosis date
- HF patients baseline characteristic record
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, Peking University First Hospital
Beijing, 100034
About this study
Official title: Heart Failure Treatment Pattern Analysis of HF Patients in HF Centers and Non-HF Centers in China: a Retrospective Database-based Study
This is a retrospective, researcher-initiated, database-based study that will retrospectively observe the treatment and medication patterns of about 22,500 patients with heart failure from 25 heart failure centers and 25 non-heart failure centers in the database of heart failure center. The proportion of patients with heart failure treatment drugs reaching the target dose recommended in the guidelines and discontinuation rate will be observed at 1 month, 3 months and 12 months follow up time point. The purpose of this study is to illustrate the current HF treatment status in HF center hospitals and non-HF center hospitals, which may provide insights for improving the clinical practice of heart failure treatment in China, and promote the standardization of heart failure treatment in China.
- Conditions
- Heart Failure
- Being tested
- no intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| HF center | heart failure patients enrolled from heart failure center hospitals Receives: Other: no intervention | |
| non-HF center | heart failure patients enrolled from non-heart failure center hospitals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of GDMT drugs (classified as RAASi (including ARNI), beta blockers, MRA and SGLT2i)
Numbers of GDMT drugs of HF patients stratified by HF ejection fraction and by HF Center and Non-HF Center
Measured: At baseline and at 1 month, 3 month, 12 month follow-up time point
Use rates of GDMT drugs
The percentage of patients using each GDMT drug，stratified by HF ejection fraction and by HF Center and Non-HF Center
Measured: At baseline and at 1 month, 3 month, 12 month follow-up time point
Secondary outcomes (5)
The proportion of patients using 2 types of GDMT drugs
The percentage of patients using 2 of any 4 GDMT drugs，stratified by HF ejection fraction and by HF Center and Non-HF Center
Measured: At baseline and at 1 month, 3 month, 12 month follow-up time point
The proportion of patients using 3 types of GDMT drugs
The percentage of patients using 3 of any 4 GDMT drugs，stratified by HF ejection fraction and by HF Center and Non-HF Center
Measured: At baseline and at 1 month, 3 month, 12 month follow-up time point
The proportion of patients using 4 types of GDMT drugs
The percentage of patients using all types of GDMT drugs，stratified by HF ejection fraction and by HF Center and Non-HF Center
Measured: At baseline and at 1 month, 3 month, 12 month follow-up time point
The proportion of patients with each GDMT drug in the target dose
The percentage of patients who achieved the target dose of each GDMT drug, stratified by HF ejection fraction and by HF Center and Non-HF Center
Measured: at 1 month, 3 month, 12 month follow-up time point
Discontinuation rate of each GDMT drug
The percentage of patients who discontinued GDMT drugs, stratified by HF ejection fraction and by HF Center and Non-HF Center
Measured: at 1 month, 3 month, 12 month follow-up time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Sep 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Cardiovascular Association, AstraZeneca
- Responsible party
- Principal investigator, Yong Huo, Peking University First Hospital
- Investigators
- Huo Yong, MD., Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099028
- Sponsor's protocol ID
- ESR-22-22035
- Status last verified
- Jan 2024
- First submitted
- 17 Sep 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
PubMed 30496104Cowie MR, Anker SD, Cleland JGF, Felker GM, Filippatos G, Jaarsma T, Jourdain P, Knight E, Massie B, Ponikowski P, Lopez-Sendon J. Improving care for patients with acute heart failure: before, during and after hospitalization. ESC Heart Fail. 2014 Dec;1(2):110-145. doi: 10.1002/ehf2.12021. Epub 2015 Jan 21.
PubMed 28834628Groenewegen A, Rutten FH, Mosterd A, Hoes AW. Epidemiology of heart failure. Eur J Heart Fail. 2020 Aug;22(8):1342-1356. doi: 10.1002/ejhf.1858. Epub 2020 Jun 1.
PubMed 32483830Jones NR, Roalfe AK, Adoki I, Hobbs FDR, Taylor CJ. Survival of patients with chronic heart failure in the community: a systematic review and meta-analysis. Eur J Heart Fail. 2019 Nov;21(11):1306-1325. doi: 10.1002/ejhf.1594. Epub 2019 Sep 16.
PubMed 31523902Setoguchi S, Stevenson LW, Schneeweiss S. Repeated hospitalizations predict mortality in the community population with heart failure. Am Heart J. 2007 Aug;154(2):260-6. doi: 10.1016/j.ahj.2007.01.041.
PubMed 17643574Bottle A, Kim D, Aylin P, Cowie MR, Majeed A, Hayhoe B. Routes to diagnosis of heart failure: observational study using linked data in England. Heart. 2018 Apr;104(7):600-605. doi: 10.1136/heartjnl-2017-312183. Epub 2017 Oct 5.
PubMed 28982720Lawson CA, Zaccardi F, Squire I, Ling S, Davies MJ, Lam CSP, Mamas MA, Khunti K, Kadam UT. 20-year trends in cause-specific heart failure outcomes by sex, socioeconomic status, and place of diagnosis: a population-based study. Lancet Public Health. 2019 Aug;4(8):e406-e420. doi: 10.1016/S2468-2667(19)30108-2.
PubMed 31376859Ghazi L, Yamamoto Y, Riello RJ, Coronel-Moreno C, Martin M, O'Connor KD, Simonov M, Huang J, Olufade T, McDermott J, Dhar R, Inzucchi SE, Velazquez EJ, Wilson FP, Desai NR, Ahmad T. Electronic Alerts to Improve Heart Failure Therapy in Outpatient Practice: A Cluster Randomized Trial. J Am Coll Cardiol. 2022 Jun 7;79(22):2203-2213. doi: 10.1016/j.jacc.2022.03.338. Epub 2022 Apr 3.
PubMed 35385798McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
PubMed 34447992Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1.
PubMed 35379503
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Treatment Pattern Analysis of HF Patients in HF Centers and Non-HF Centers in China: a Retrospective Database-based Study
- ClinicalTrials.gov ID
- NCT06099028
- Acronym / sponsor ID
- ESR-22-22035
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,500 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- China Cardiovascular Association, AstraZeneca
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 25 Oct 2023 (actual)
- 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 is a retrospective, researcher-initiated, database-based study that will retrospectively observe the treatment and medication patterns of about 22,500 patients with heart failure from 25 heart failure centers and 25 non-heart failure centers in the database of heart failure center. The proportion of patients with heart failure treatment drugs reaching the target dose recommended in the guidelines and discontinuation rate will be observed at 1 month, 3 months and 12 months follow up time point. The purpose of this study is to illustrate the current HF treatment status in HF center hospitals and non-HF center hospitals, which may provide insights for improving the clinical practice of heart failure treatment in China, and promote the standardization of heart failure treatment in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HF center | – | Other: no interventionheart failure patients enrolled from heart failure center hospitals |
| non-HF center | – | –heart failure patients enrolled from non-heart failure center hospitals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include HF patients extracted from the HF centers Database. The enrolment of HF cases was via the consecutive sampling. In this study, the study time frame is from 2021.09 to 2023.03. The index date will be defined as the discharge date after the first HF admission (inpatient) record shown in the database, (i.e., the discharge date is the date entry into the HF centers Database). Given that previous treatment condition of these patients before the enrolment in this database is unknown, the baseline information was only collected at the index date. Patient follow-ups were scheduled at 1 month, 3 months and 12 months after the first discharge. The window of follow-up was set for ±14 days.
Key inclusion criteria (3 listed)
- An index HF diagnosis date in the records
- Age ≥ 18 years old at initial diagnosis date
- HF patients baseline characteristic record
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| no interventionno intervention | Other | HF center |
Primary outcome
Number of GDMT drugs (classified as RAASi (including ARNI), beta blockers, MRA and SGLT2i)
Time frame: At baseline and at 1 month, 3 month, 12 month follow-up time point
Numbers of GDMT drugs of HF patients stratified by HF ejection fraction and by HF Center and Non-HF Center
Use rates of GDMT drugs
Time frame: At baseline and at 1 month, 3 month, 12 month follow-up time point
The percentage of patients using each GDMT drug，stratified by HF ejection fraction and by HF Center and Non-HF Center
5 secondary outcomes
The proportion of patients using 2 types of GDMT drugs
Time frame: At baseline and at 1 month, 3 month, 12 month follow-up time point
The proportion of patients using 3 types of GDMT drugs
Time frame: At baseline and at 1 month, 3 month, 12 month follow-up time point
The proportion of patients using 4 types of GDMT drugs
Time frame: At baseline and at 1 month, 3 month, 12 month follow-up time point
The proportion of patients with each GDMT drug in the target dose
Time frame: at 1 month, 3 month, 12 month follow-up time point
Discontinuation rate of each GDMT drug
Time frame: at 1 month, 3 month, 12 month follow-up time point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Background: PubMed 30496104GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.
- Background: PubMed 28834628Cowie MR, Anker SD, Cleland JGF, Felker GM, Filippatos G, Jaarsma T, Jourdain P, Knight E, Massie B, Ponikowski P, Lopez-Sendon J. Improving care for patients with acute heart failure: before, during and after hospitalization. ESC Heart Fail. 2014 Dec;1(2):110-145. doi: 10.1002/ehf2.12021. Epub 2015 Jan 21.
- Background: PubMed 32483830Groenewegen A, Rutten FH, Mosterd A, Hoes AW. Epidemiology of heart failure. Eur J Heart Fail. 2020 Aug;22(8):1342-1356. doi: 10.1002/ejhf.1858. Epub 2020 Jun 1.
- Background: PubMed 31523902Jones NR, Roalfe AK, Adoki I, Hobbs FDR, Taylor CJ. Survival of patients with chronic heart failure in the community: a systematic review and meta-analysis. Eur J Heart Fail. 2019 Nov;21(11):1306-1325. doi: 10.1002/ejhf.1594. Epub 2019 Sep 16.
- Background: PubMed 17643574Setoguchi S, Stevenson LW, Schneeweiss S. Repeated hospitalizations predict mortality in the community population with heart failure. Am Heart J. 2007 Aug;154(2):260-6. doi: 10.1016/j.ahj.2007.01.041.
- Background: PubMed 28982720Bottle A, Kim D, Aylin P, Cowie MR, Majeed A, Hayhoe B. Routes to diagnosis of heart failure: observational study using linked data in England. Heart. 2018 Apr;104(7):600-605. doi: 10.1136/heartjnl-2017-312183. Epub 2017 Oct 5.
- Background: PubMed 31376859Lawson CA, Zaccardi F, Squire I, Ling S, Davies MJ, Lam CSP, Mamas MA, Khunti K, Kadam UT. 20-year trends in cause-specific heart failure outcomes by sex, socioeconomic status, and place of diagnosis: a population-based study. Lancet Public Health. 2019 Aug;4(8):e406-e420. doi: 10.1016/S2468-2667(19)30108-2.
- Background: PubMed 35385798Ghazi L, Yamamoto Y, Riello RJ, Coronel-Moreno C, Martin M, O'Connor KD, Simonov M, Huang J, Olufade T, McDermott J, Dhar R, Inzucchi SE, Velazquez EJ, Wilson FP, Desai NR, Ahmad T. Electronic Alerts to Improve Heart Failure Therapy in Outpatient Practice: A Cluster Randomized Trial. J Am Coll Cardiol. 2022 Jun 7;79(22):2203-2213. doi: 10.1016/j.jacc.2022.03.338. Epub 2022 Apr 3.
- Background: PubMed 34447992McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
- Background: PubMed 35379503Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1.
- Individual participant dataSharing planned: No
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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.
Huo Yong, MD. principal investigator
Peking University First Hospital
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 Peking University First Hospital 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 0 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: finished, as of the sponsor's last update on 23 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of GDMT drugs (classified as RAASi (including ARNI), beta blockers, MRA and SGLT2i) (time frame: At baseline and at 1 month, 3 month, 12 month follow-up time point). The study lists 2 primary outcomes in all. 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 NCT06099028, which also lists 10 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 23 Jan 2024.