Outcome of Cardiomyopathic Adults Admission in ICU.

Cardiomyopathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05567445
• Other study ID #: Cardiomyopathy in ICU.
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: October 2024

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: Mohammed Ahmed Abdelhmied, Doctor
• Phone: 01147349160
• Email: Abdelhmied22[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies

Intervention

Diagnostic Test:
• Echocardiography, CBC, Liver function, kideny function
Echocardiography, AST, ALT, UREA,CREAT. , CBC,may blood cultures.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

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. — View Citation

Lange LG, Schreiner GF. Immune mechanisms of cardiac disease. N Engl J Med. 1994 Apr 21;330(16):1129-35. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 Ö, Pavlovic SU, Piepoli MF, Ristic AD, Rosano GMC, Seggewiss H, Ašanin 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, Tschöpe 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. — View Citation

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. — View Citation

Outcome

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

External Links

•   Characteristics and outcomes of patients hospitalized for heart failure in the United States: Rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE)
•   Heart failure and sepsis: practical recommendations for the optimal management
•   Heart Failure in Acute Ischemic Stroke