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

NCT06099028 | Completed

• 1 other identifier: ESR-22-22035
• Study Type: observational
• Target: 22,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• The proportion of patients using 2 types of GDMT drugs

  At baseline and at 1 month, 3 month, 12 month follow-up time point

• The proportion of patients using 3 types of GDMT drugs

  At baseline and at 1 month, 3 month, 12 month follow-up time point

• The proportion of patients using 4 types of GDMT drugs

  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

  at 1 month, 3 month, 12 month follow-up time point

• Discontinuation rate of each GDMT drug

  at 1 month, 3 month, 12 month follow-up time point

Study Arms (2)

HF center

heart failure patients enrolled from heart failure center hospitals

Other: no intervention

non-HF center

heart failure patients enrolled from non-heart failure center hospitals

Interventions

no intervention OTHER

no intervention

HF center

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• An index HF diagnosis date in the records
• Age ≥ 18 years old at initial diagnosis date
• HF patients baseline characteristic record

Sponsors & Collaborators

• Peking University First Hospital: lead
• China Cardiovascular Association: collaborator
• AstraZeneca: collaborator

Study Sites (1)

Department of Cardiology, Peking University First Hospital

Beijing, 100034, China

Location

Related Publications (10)

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  PMID: 30496104 BACKGROUND

• 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.

  PMID: 28834628 BACKGROUND

• 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.

  PMID: 32483830 BACKGROUND

• 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.

  PMID: 31523902 BACKGROUND

• 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.

  PMID: 17643574 BACKGROUND

• 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.

  PMID: 28982720 BACKGROUND

• 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.

  PMID: 31376859 BACKGROUND

• 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.

  PMID: 35385798 BACKGROUND

• 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.

  PMID: 34447992 BACKGROUND

• 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.

  PMID: 35379503 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Huo Yong, MD.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: October 25, 2023
• Study Start: September 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)