CClinicalTrials.gg
Not yet recruitingNCT06158711Updated Dec 6, 2023

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

An observational study in Heart Failure, sponsored by Qianfoshan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-06.

Sponsored by Qianfoshan Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 8 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
702
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The purpose of this study is to evaluate the efficacy and cost-effective of different drugs co-administration in the treatment of heart failure. For different reasons, patients with heart failure took different drug prescriptions. Now there are five kinds of drugs for the treatment of heart failure, such as angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACEI/ARB), beta-blokers, spironolactone, sodium-glucose cotransporter (sglt) 2 inhibitors and vericiguat. Our purpose is to assessment the efficacy and cost-effective of different drugs co-administration in the treatment of heart failure.

02

Conditions studied

  • Heart Failure

Browse trials for

03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 702 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Qianfoshan Hospital is the lead sponsor of 140 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Severe impairment of liver, kidney and lung function (transaminase increased more than 2 times; Scr > 265umol/L); malignant tumor
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
702 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Admission to hospital and 12 months thereafter

  2. 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).

    Time frame: Admission to hospital and 12 months thereafter

  3. Hospital mortality

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

    Time frame: Index hospital stay

Secondary outcomes

  1. Days of hospitalization and expenses of patients

    The hospitalization days and expenses of patients admitted with different drugs treatment were examined.

    Time frame: Index hospital stay

  2. degree of lower limb edema (mild, moderate, severe)

    Lower-extremity edema is one of the important factors in diagnosing, monitoring, and managing HF status. A senior cardiologist checked carefully for the presence of bilateral lower-extremity edema and graded its severity on a scale of 1 of 4 based on the extent of the edema in the leg, as follows: (1) none, (2) up to the height of the ankle level (mild edema), (3) up to the height of the knee (moderate edema), and (4) higher than knee level (severe edema).

    Time frame: Admission to hospital and 12 months thereafter

  3. 6-minute walking test

    The 6-minute walking test (6MWT) is a widely available and well-tolerated test for the assessment of the functional capacity of patients with HF.

    Time frame: Admission to hospital and 12 months thereafter

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 28982506 ↗
  • 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. PubMed 34101002 ↗
  • 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. PubMed 28461007 ↗
  • 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. Erratum In: Eur Heart J. 2018 Mar 7;39(10):860. doi: 10.1093/eurheartj/ehw383. PubMed 27206819 ↗
  • 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. PubMed 32446323 ↗
  • 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. PubMed 33852110 ↗
  • 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. PubMed 35083827 ↗
  • 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. PubMed 35363500 ↗
  • 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. PubMed 36722326 ↗

Individual participant data

Plan to share: Yes — patient characteristics and clinical outcomes

Supporting information: Study protocol, Sap

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06158711
Lead sponsor
Qianfoshan Hospital
Responsible party
Guang Yang (Director of Department of Gerontology/ Health Care and Medicine (Cardiology) , the First Affiliated Hospital of Shandong First Medical University &Shandong Provincial Qianfoshan Hospital, Qianfoshan Hospital) — Principal investigator
First posted
Dec 6, 2023
Start date
Nov 30, 2023 (estimated)
Primary completion
Jan 31, 2024 (estimated)
Completion
Jul 31, 2024 (estimated)
Last update
Dec 6, 2023

Study contacts

Guang Yang, Phd
Contact
yang1972@126.com
15550053917
Guang Yang, PhD
principal investigator · Qianfoshan Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion