Real-world Research : Assessment of Effect of Combination of Drugs in the Treatment of Heart Failure

NCT06158711 | Unknown DMC

• 1 other identifier: Qianfoshan HF 2023
• Study Type: observational
• Target: 702
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to assess the effect of the different combination of drugs in the treatment of heart failure. The main questions it aims to answer are:

• \[question 1\] The changes of BNP and LVEF in patients of each groups with different drugs co-administration.
• \[question 2\] The days of hospitalization, degree of lower limb edema (mild, moderate, severe) and 6-minute walking test in each groups. Participants will be asked to do nothing. All the records of the patients will be download from the Big Data Cloud Platform of Health Care in the First Affiliated Hospital of Shandong First Medical University. There is not a comparison group.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• The B-type natriuretic peptide (BNP)

  B-type natriuretic peptide (BNP) is a marker of heart failure. Its levels can be measured with a rapid and commercially available bed-side assay. Rising levels correlate with the degree of left ventricular dysfunction and severity of symptoms.

  Admission to hospital and 12 months thereafter

• Left ventricular ejection fraction (LVEF) of patients

  Echocardiography is the gold standard for establishing the presence of left ventricular dysfunction. Left ventricular ejection fraction (LVEF) is the central measure of left ventricular systolic function. LVEF is the fraction of chamber volume ejected in systole (stroke volume) in relation to the volume of the blood in the ventricle at the end of diastole (end-diastolic volume).

  Admission to hospital and 12 months thereafter

• Hospital mortality

  We recorded the death from heart failure, no matter the mode of death.

  Index hospital stay

Secondary Outcomes (3)

• Days of hospitalization and expenses of patients

  Index hospital stay

• degree of lower limb edema (mild, moderate, severe)

  Admission to hospital and 12 months thereafter

• 6-minute walking test

  Admission to hospital and 12 months thereafter

Study Arms (1)

single drug group, two drugs group, three drugs group and four drugs group

single drug group, patients with heart failure only took one sort of drugs two drugs group, patients with heart failure took two sorts of drugs three drugs group, patients with heart failure took three sorts of drugs four drugs group, patients with heart failure took four sorts of drugs

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 hospitalized patients who were treated in the First Affiliated Hospital of Shandong First Medical School from January 2013.to October 2023

You may qualify if:

• Patients diagnosed as "heart failure" or "cardiac insufficiency" on the first page of the medical record

You may not qualify if:

• Severe impairment of liver, kidney and lung function (transaminase increased more than 2 times; Scr \> 265umol/L); malignant tumor

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Related Publications (9)

• Kavalieratos D, Gelfman LP, Tycon LE, Riegel B, Bekelman DB, Ikejiani DZ, Goldstein N, Kimmel SE, Bakitas MA, Arnold RM. Palliative Care in Heart Failure: Rationale, Evidence, and Future Priorities. J Am Coll Cardiol. 2017 Oct 10;70(15):1919-1930. doi: 10.1016/j.jacc.2017.08.036.

  PMID: 28982506 BACKGROUND

• Shen L, Claggett BL, Jhund PS, Abraham WT, Desai AS, Dickstein K, Gong J, Kober LV, Lefkowitz MP, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, McMurray JJV. Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE. Clin Res Cardiol. 2021 Aug;110(8):1334-1349. doi: 10.1007/s00392-021-01888-x. Epub 2021 Jun 8.

  PMID: 34101002 BACKGROUND

• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017 Aug 8;70(6):776-803. doi: 10.1016/j.jacc.2017.04.025. Epub 2017 Apr 28. No abstract available.

  PMID: 28461007 BACKGROUND

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

  PMID: 27206819 BACKGROUND

• Vaduganathan M, Claggett BL, Jhund PS, Cunningham JW, Pedro Ferreira J, Zannad F, Packer M, Fonarow GC, McMurray JJV, Solomon SD. Estimating lifetime benefits of comprehensive disease-modifying pharmacological therapies in patients with heart failure with reduced ejection fraction: a comparative analysis of three randomised controlled trials. Lancet. 2020 Jul 11;396(10244):121-128. doi: 10.1016/S0140-6736(20)30748-0. Epub 2020 May 21.

  PMID: 32446323 BACKGROUND

• Castiglione V, Aimo A, Vergaro G, Saccaro L, Passino C, Emdin M. Biomarkers for the diagnosis and management of heart failure. Heart Fail Rev. 2022 Mar;27(2):625-643. doi: 10.1007/s10741-021-10105-w. Epub 2021 Apr 14.

  PMID: 33852110 BACKGROUND

• Authors/Task Force Members:; 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: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.

  PMID: 35083827 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: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e876-e894. doi: 10.1161/CIR.0000000000001062. Epub 2022 Apr 1.

  PMID: 35363500 BACKGROUND

• Ji PJ, Zhang ZY, Yan Q, Cao HL, Zhao YJ, Yang B, Li J. The cardiovascular effects of SGLT2 inhibitors, RAS inhibitors, and ARN inhibitors in heart failure. ESC Heart Fail. 2023 Apr;10(2):1314-1325. doi: 10.1002/ehf2.14298. Epub 2023 Feb 1.

  PMID: 36722326 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Guang Yang, PhD

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guang Yang, Phd

CONTACT

15550053917; yang1972@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gerontology/ Health Care and Medicine (Cardiology) , the First Affiliated Hospital of Shandong First Medical University &Shandong Provincial Qianfoshan Hospital

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 6, 2023
• Study Start: November 30, 2023
• Primary Completion: January 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From 2024-8-1to 2027-8-1
• Access Criteria: No criteria