NCT05567445

Brief Summary

To study the outcome of the cardiac function, and clinical status of the patiants with cardiomyopathy who are admitted in the I.C.U.

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
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Status
unknown

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

September 27, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

September 27, 2022

Last Update Submit

October 4, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Effect on E.F.

    Degree of impairement of E.F.

    through study completion, an average of 1 year

  • Effect on renal function

    Who developed renal impairement, and its effect on cardiac function.

    through study completion, an average of 1 year

  • Sepsis

    Who developed sepsis and its effect on cardiac function.

    through study completion, an average of 1 year

  • Effect on liver function

    Who suffer liver function impairement, improvement or deteroriation

    through study completion, an average of 1 year

Interventions

Echocardiography, AST, ALT, UREA,CREAT. , CBC,may blood cultures.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiomyopathic patiants with the previous inclusion criteria.

You may qualify if:

  • Cardiomyopathic patiants admitted with heart failure diagonsed clinicaly , by Echocardiograph , or by ECG.
  • Dilated cardiomyopathy\[ Unknown, Uremic cardiomyopathy, Post-partum, Ishemic\].
  • Hypertrophic cardiomyopathy.
  • Acute heart failure caused by A.C.S. , Toxic myocardititis.

You may not qualify if:

  • Heart failure due to valvular heart disease.
  • Heart failure caused by hypertension.
  • patiant with COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Seferovic PM, Polovina M, Bauersachs J, Arad M, Ben Gal T, Lund LH, Felix SB, Arbustini E, Caforio ALP, Farmakis D, Filippatos GS, Gialafos E, Kanjuh V, Krljanac G, Limongelli G, Linhart A, Lyon AR, Maksimovic R, Milicic D, Milinkovic I, Noutsias M, Oto A, Oto O, Pavlovic SU, Piepoli MF, Ristic AD, Rosano GMC, Seggewiss H, Asanin M, Seferovic JP, Ruschitzka F, Celutkiene J, Jaarsma T, Mueller C, Moura B, Hill L, Volterrani M, Lopatin Y, Metra M, Backs J, Mullens W, Chioncel O, de Boer RA, Anker S, Rapezzi C, Coats AJS, Tschope C. Heart failure in cardiomyopathies: a position paper from the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2019 May;21(5):553-576. doi: 10.1002/ejhf.1461. Epub 2019 Apr 16.

    PMID: 30989768BACKGROUND
  • Rodriguez FH 3rd, Moodie DS, Parekh DR, Franklin WJ, Morales DL, Zafar F, Adams GJ, Friedman RA, Rossano JW. Outcomes of heart failure-related hospitalization in adults with congenital heart disease in the United States. Congenit Heart Dis. 2013 Nov-Dec;8(6):513-9. doi: 10.1111/chd.12019. Epub 2012 Nov 16.

    PMID: 23164196BACKGROUND
  • Lange LG, Schreiner GF. Immune mechanisms of cardiac disease. N Engl J Med. 1994 Apr 21;330(16):1129-35. doi: 10.1056/NEJM199404213301607.

    PMID: 8133856BACKGROUND
  • Matsubara I, Tedo I. [Study on the respiratory failure with cardiac failure--focus on hypoventilation respiratory failure]. Kokyu To Junkan. 1990 Aug;38(8):785-9. Japanese.

    PMID: 2218087BACKGROUND
  • Platz E, Jhund PS, Claggett BL, Pfeffer MA, Swedberg K, Granger CB, Yusuf S, Solomon SD, McMurray JJ. Prevalence and prognostic importance of precipitating factors leading to heart failure hospitalization: recurrent hospitalizations and mortality. Eur J Heart Fail. 2018 Feb;20(2):295-303. doi: 10.1002/ejhf.901. Epub 2017 Sep 4.

    PMID: 28872259BACKGROUND
  • Ahmed A, Allman RM, Fonarow GC, Love TE, Zannad F, Dell'italia LJ, White M, Gheorghiade M. Incident heart failure hospitalization and subsequent mortality in chronic heart failure: a propensity-matched study. J Card Fail. 2008 Apr;14(3):211-8. doi: 10.1016/j.cardfail.2007.12.001.

    PMID: 18381184BACKGROUND
  • van Deursen VM, Damman K, Hillege HL, van Beek AP, van Veldhuisen DJ, Voors AA. Abnormal liver function in relation to hemodynamic profile in heart failure patients. J Card Fail. 2010 Jan;16(1):84-90. doi: 10.1016/j.cardfail.2009.08.002. Epub 2009 Sep 26.

    PMID: 20123323BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for liver function, kideny function, CBC, BLOOD CULTURES.

MeSH Terms

Conditions

Cardiomyopathies

Interventions

EchocardiographyBlood Cell Count

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularCell CountCytological TechniquesClinical Laboratory TechniquesHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Ahmed Mohammed Aly Obied-Allah, Ass.prof.

    Assiut University

    STUDY DIRECTOR
  • NoorEldeen Abd-El Azeem M.EL- Hefny, Prof

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mohammed Ahmed Abdelhmied, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 5, 2022

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

October 6, 2022

Record last verified: 2022-10