CardiomyopathiesNCT05567445
Outcome of Cardiomyopathic Adults Admission in ICU.
An observational study of Cardiomyopathies, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathies
- What is being tested?
- Echocardiography, CBC, Liver function, kideny function
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Oct 2024
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cardiomyopathic patiants with the previous inclusion criteria.
Who may be able to join
- 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.
Who cannot join
- Heart failure due to valvular heart disease.
- Heart failure caused by hypertension.
- patiant with COPD
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiomyopathies
- Being tested
- Echocardiography, CBC, Liver function, kideny function
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography, CBC, Liver function, kideny functionDiagnostic test
Echocardiography, AST, ALT, UREA,CREAT. , CBC,may blood cultures.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on E.F.
Degree of impairement of E.F.
Measured: through study completion, an average of 1 year
Effect on renal function
Who developed renal impairement, and its effect on cardiac function.
Measured: through study completion, an average of 1 year
Sepsis
Who developed sepsis and its effect on cardiac function.
Measured: through study completion, an average of 1 year
Effect on liver function
Who suffer liver function impairement, improvement or deteroriation
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ahmed Abd-Elhmied Mohammed, Assiut University
- Investigators
- Ahmed Mohammed Aly Obied-Allah, Ass.prof., Study director, Assiut UniversityNoorEldeen Abd-El Azeem M.EL- Hefny, Prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567445
- Sponsor's protocol ID
- Cardiomyopathy in ICU.
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30989768Rodriguez 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.
PubMed 23164196Lange LG, Schreiner GF. Immune mechanisms of cardiac disease. N Engl J Med. 1994 Apr 21;330(16):1129-35. doi: 10.1056/NEJM199404213301607.
PubMed 8133856Matsubara 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.
PubMed 2218087Platz 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.
PubMed 28872259Ahmed 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.
PubMed 18381184van 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.
PubMed 20123323
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Outcomes of Heart Failure-Related Intensive Care Unit Admissions in Adults With Cardiomyopathy.
- ClinicalTrials.gov ID
- NCT05567445
- Acronym / sponsor ID
- Cardiomyopathy in ICU.
- Conditions
- Cardiomyopathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the outcome of the cardiac function, and clinical status of the patiants with cardiomyopathy who are admitted in the I.C.U.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiomyopathic patiants with the previous inclusion criteria.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Heart failure due to valvular heart disease.
- Heart failure caused by hypertension.
- patiant with COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography, CBC, Liver function, kideny functionEchocardiography, AST, ALT, UREA,CREAT. , CBC,may blood cultures. | Diagnostic test | – |
Primary outcome
Effect on E.F.
Time frame: through study completion, an average of 1 year
Degree of impairement of E.F.
Effect on renal function
Time frame: through study completion, an average of 1 year
Who developed renal impairement, and its effect on cardiac function.
Sepsis
Time frame: through study completion, an average of 1 year
Who developed sepsis and its effect on cardiac function.
Effect on liver function
Time frame: through study completion, an average of 1 year
Who suffer liver function impairement, improvement or deteroriation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Background: PubMed 30989768Seferovic 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.
- Background: PubMed 23164196Rodriguez 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.
- Background: PubMed 8133856Lange LG, Schreiner GF. Immune mechanisms of cardiac disease. N Engl J Med. 1994 Apr 21;330(16):1129-35. doi: 10.1056/NEJM199404213301607.
- Background: PubMed 2218087Matsubara 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.
- Background: PubMed 28872259Platz 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.
- Background: PubMed 18381184Ahmed 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.
- Background: PubMed 20123323van 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.
- Heart failure and sepsis: practical recommendations for the optimal managementLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Mohammed Aly Obied-Allah, Ass.prof. study director
Assiut University
NoorEldeen Abd-El Azeem M.EL- Hefny, Prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathies, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Ahmed Abdelhmied, Doctor (01147349160, Abdelhmied22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect on E.F. (time frame: through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05567445, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2022.