Heart Failure Treatment Pattern Analysis of HF Patients in HF Centers and Non-HF Centers in China

Heart Failure Clinical Trial

Official title:

Heart Failure Treatment Pattern Analysis of HF Patients in HF Centers and Non-HF Centers in China: a Retrospective Database-based Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06099028
• Other study ID #: ESR-22-22035
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2024
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22500
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• An index HF diagnosis date in the records

• Age = 18 years old at initial diagnosis date

• HF patients baseline characteristic record

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Department of Cardiology, Peking University First Hospital	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University First Hospital	AstraZeneca, China Cardiovascular Association

Country where clinical trial is conducted

China, 

References & Publications (10)

Bottle 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. — View Citation

Cowie 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. — View Citation

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. Erratum In: Lancet. 2019 Jun 22;393(10190):e44. — View Citation

Ghazi 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. — View Citation

Groenewegen 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. — View Citation

Heidenreich 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. Erratum In: J Am Coll Cardiol. 2023 Apr 18;81(15):1551. — View Citation

Jones 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. — View Citation

Lawson 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. — View Citation

McDonagh 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. Erratum In: Eur Heart J. 2021 Oct 14;: — View Citation

Setoguchi 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At baseline and at 1 month, 3 month, 12 month follow-up time point
Primary	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	At baseline and at 1 month, 3 month, 12 month follow-up time point
Secondary	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	At baseline and at 1 month, 3 month, 12 month follow-up time point
Secondary	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	At baseline and at 1 month, 3 month, 12 month follow-up time point
Secondary	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	At baseline and at 1 month, 3 month, 12 month follow-up time point
Secondary	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	at 1 month, 3 month, 12 month follow-up time point
Secondary	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	at 1 month, 3 month, 12 month follow-up time point