Outcome of Cardiomyopathic Adults Admission in ICU.

October 4, 2022 updated by: Mohammed Ahmed Abd-Elhmied Mohammed, Assiut University

Characteristics and Outcomes of Heart Failure-Related Intensive Care Unit Admissions in Adults With Cardiomyopathy.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiomyopathic patiants with the previous inclusion criteria.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on E.F.
Time Frame: through study completion, an average of 1 year
Degree of impairement of E.F.
through study completion, an average of 1 year
Effect on renal function
Time Frame: through study completion, an average of 1 year
Who developed renal impairement, and its effect on cardiac function.
through study completion, an average of 1 year
Sepsis
Time Frame: through study completion, an average of 1 year
Who developed sepsis and its effect on cardiac function.
through study completion, an average of 1 year
Effect on liver function
Time Frame: through study completion, an average of 1 year
Who suffer liver function impairement, improvement or deteroriation
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2023

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

October 1, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cardiomyopathy in ICU.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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