Outcome of Cardiomyopathic Adults Admission in ICU.

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05567445
Collaborator
(none)
45
13

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Echocardiography, CBC, Liver function, kideny function

Detailed Description

Heart failure is not a single pathological diagnosis, but a clinical syndrome consisting of cardinal symptoms (e.g. breathlessness, ankle swelling, and fatigue) that may be accompanied by signs (e.g. elevated jugular venous pressure, pulmonary crackles, and peripheral oedema). It is due to a structural and/or functional abnormality of the heart that results in elevated intracardiac pressures and/or inadequate cardiac output at rest and/or during exercise. Identification of the aetiology of the underlying cardiac dysfunction is mandatory in the diagnosis of HF as the specific pathology can determine subsequent treatment. Most commonly, HF is due to myocardial dysfunction: either systolic, diastolic, or both. However, pathology of the valves, pericardium, and endocardium, and abnormalities of heart rhythm and conduction can also cause or contribute to HF.

Cardiomyopathies are defined by the WHO as diseases of the myocardium associated with cardiac dysfunction, Cardiomyopathies are categorized into dilated, restrictive, hypertrophic, and unclassified based on the predominant pathophysiologic characteristics. A new category has been added to include right ventricular abnormalities. The disorders that are associated with systemic or certain cardiac diseases are called specific heart muscle diseases and include ischemic cardiomyopathy, valvular, hypertensive, inflammatory, metabolic, peripartal, general systemic disease, muscular dystrophies, neuromuscular disorders, and toxic and hypersensitivity reactions. The unclassified cardiomyopathy category includes disorders such as fibroelastosis, noncompacted myocardium, and systolic dysfunction with minimal dilation.

Patiant admitted in I.C.U. with heart failure who already have cardiomyopathy Some patiants discharge without any comorbidies and some acquire renal failure, respiratory failure,MCS, sepsis, and some were associated with mortality . Significant comorbidities associated with these hospitalizations included arrhythmias, renal failure , cerebrovascular disease, and hepatic impairment.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Characteristics and Outcomes of Heart Failure-Related Intensive Care Unit Admissions in Adults With Cardiomyopathy.
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Effect on E.F. [through study completion, an average of 1 year]

    Degree of impairement of E.F.

  2. Effect on renal function [through study completion, an average of 1 year]

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

  3. Sepsis [through study completion, an average of 1 year]

    Who developed sepsis and its effect on cardiac function.

  4. Effect on liver function [through study completion, an average of 1 year]

    Who suffer liver function impairement, improvement or deteroriation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Cardiomyopathic patiants admitted with heart failure diagonsed clinicaly , by Echocardiograph , or by ECG.

  1. Dilated cardiomyopathy[ Unknown, Uremic cardiomyopathy, Post-partum, Ishemic].

  2. Hypertrophic cardiomyopathy.

  3. Acute heart failure caused by A.C.S. , Toxic myocardititis.

Exclusion Criteria:
  1. Heart failure due to valvular heart disease.

  2. Heart failure caused by hypertension.

  3. patiant with COPD

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Ahmed Mohammed Aly Obied-Allah, Ass.prof., Assiut University
  • Study Director: NoorEldeen Abd-El Azeem M.EL- Hefny, Prof, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Mohammed Ahmed Abd-Elhmied Mohammed, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05567445
Other Study ID Numbers:
  • Cardiomyopathy in ICU.
First Posted:
Oct 5, 2022
Last Update Posted:
Oct 6, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2022