NCT06453967

Brief Summary

To evaluate the effect of blood glucose level at admission and glucose variability during ICU admission and their effect on in-hospital morbidity and mortality in patients admitted with acute decompensated heart failure

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

April 15, 2024

Last Update Submit

June 10, 2024

Conditions

Keywords

glucose variability

Outcome Measures

Primary Outcomes (1)

  • To evaluate the effect of glucose variability during ICU admission on in-hospital morbidity and mortality in patients admitted with acute decompensated heart failure ▪

    Glycaemic variability can be measured by Standard deviation of glucose, Coefficient of variation of glucose, Mean amplitude of glucose excursion ,glycemic lability index

    1 year

Interventions

blood glucose levelsDIAGNOSTIC_TEST

measurement of blood glucose level at admission ,during ICU admission and at discharge for patients with acute decompensated heart failure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed as acute decompensated heart failure and admitted to critical care unit will be recurited in this study either diabetic or not

You may qualify if:

  • All patients admitted with acute decompensated heart failure will be recruited in the study.

You may not qualify if:

  • Patients on chronic steroid therapy Patients diagnosed with right sided heart failure due to chest disease Patients with malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Zhou Y, Liu L, Huang H, Li N, He J, Yao H, Tang X, Chen X, Zhang S, Shi Q, Qu F, Wang S, Wang M, Shu C, Zeng Y, Tian H, Zhu Y, Su B, Li S; WECODe Study Group. 'Stress hyperglycemia ratio and in-hospital prognosis in non-surgical patients with heart failure and type 2 diabetes. Cardiovasc Diabetol. 2022 Dec 26;21(1):290. doi: 10.1186/s12933-022-01728-w.

    PMID: 36572923BACKGROUND
  • Djupsjo C, Kuhl J, Andersson T, Lundback M, Holzmann MJ, Nystrom T. Admission glucose as a prognostic marker for all-cause mortality and cardiovascular disease. Cardiovasc Diabetol. 2022 Nov 26;21(1):258. doi: 10.1186/s12933-022-01699-y.

    PMID: 36435766BACKGROUND
  • Paolisso P, Foa A, Bergamaschi L, Angeli F, Fabrizio M, Donati F, Toniolo S, Chiti C, Rinaldi A, Stefanizzi A, Armillotta M, Sansonetti A, Magnani I, Iannopollo G, Rucci P, Casella G, Galie N, Pizzi C. Impact of admission hyperglycemia on short and long-term prognosis in acute myocardial infarction: MINOCA versus MIOCA. Cardiovasc Diabetol. 2021 Sep 24;20(1):192. doi: 10.1186/s12933-021-01384-6.

    PMID: 34560876BACKGROUND
  • Lee HY, Oh BH. Paradigm Shifts of Heart Failure Therapy: Do We Need Another Paradigm? Int J Heart Fail. 2020 Apr 6;2(3):145-156. doi: 10.36628/ijhf.2020.0010. eCollection 2020 Jul.

    PMID: 36262366BACKGROUND
  • Kattel S, Kasai T, Matsumoto H, Yatsu S, Murata A, Kato T, Suda S, Hiki M, Takagi A, Daida H. Association between elevated blood glucose level on admission and long-term mortality in patients with acute decompensated heart failure. J Cardiol. 2017 Apr;69(4):619-624. doi: 10.1016/j.jjcc.2016.05.013. Epub 2016 Aug 21.

    PMID: 27554050BACKGROUND
  • Cho JY, Kim KH, Lee SE, Cho HJ, Lee HY, Choi JO, Jeon ES, Kim MS, Kim JJ, Hwang KK, Chae SC, Baek SH, Kang SM, Choi DJ, Yoo BS, Ahn Y, Park HY, Cho MC, Oh BH. Admission Hyperglycemia as a Predictor of Mortality in Acute Heart Failure: Comparison between the Diabetics and Non-Diabetics. J Clin Med. 2020 Jan 6;9(1):149. doi: 10.3390/jcm9010149.

    PMID: 31935874BACKGROUND
  • Ceriello A, Catrinoiu D, Chandramouli C, Cosentino F, Dombrowsky AC, Itzhak B, Lalic NM, Prattichizzo F, Schnell O, Seferovic PM, Valensi P, Standl E; D&CVD EASD Study Group. Heart failure in type 2 diabetes: current perspectives on screening, diagnosis and management. Cardiovasc Diabetol. 2021 Nov 6;20(1):218. doi: 10.1186/s12933-021-01408-1.

    PMID: 34740359BACKGROUND
  • Pop-Busui R, Januzzi JL, Bruemmer D, Butalia S, Green JB, Horton WB, Knight C, Levi M, Rasouli N, Richardson CR. Heart Failure: An Underappreciated Complication of Diabetes. A Consensus Report of the American Diabetes Association. Diabetes Care. 2022 Jul 7;45(7):1670-1690. doi: 10.2337/dci22-0014.

    PMID: 35796765BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Ahmed Obeid Allah, Phd

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

salma Hamdy, master degree

CONTACT

mohamed hassan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 15, 2024

First Posted

June 12, 2024

Study Start

July 1, 2024

Primary Completion

May 31, 2025

Study Completion

September 30, 2025

Last Updated

June 12, 2024

Record last verified: 2024-06