Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Events
Prospective Analysis Of Cardiac Function In Cirrhotic Patients By Echocardiography And Its Correlation With Adverse Events
The cardiac abnormalities in patients with cirrhosis are already reported from the 50's, in studies of patients with alcoholic cirrhosis. Further studies have shown that these cardiac changes were caused not only by the myotoxic effects of alcohol, but also are present in many patients regardless of etiology of cirrhosis.
These changes are characterized by abnormalities of systolic contraction in patients undergoing physical or pharmacological stress, changes in diastolic function and electrophysiological changes in a clinical condition known as cirrhotic cardiomyopathy. Increased QT interval and the pre-ejection time changes are common in cirrhotic patients.
To date no studies have evaluated the clinical relevance of changes in the heart of cirrhotic patients, or their relationship with the prognosis of affected patients. Til now, researches are based on strict echocardiographic parameters, not including several modern methods of assessment of cardiac systole and diastole. New techniques, such as two-dimensional strain, can bring new diagnostic and prognostic information, and it is not reported in the literature. Therefore, the aim of this study is to determine the morphological and functional cardiac changes in patients with cirrhosis and their prognostic role by evaluating new echocardiographic parameters of systolic and diastolic readings.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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RJ
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Rio de Janeiro, RJ, Brasilien, 20551030
- Universidade do Estado do Rio de Janeiro
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Patients with cirrhosis of any etiology, diagnosed by clinical criteria and ultrasound and / or liver biopsy, which excluded patients with causes that also may affect cardiac function (hemochromatosis, Wilson disease, amyloidosis).
- Age between 18 and 80 years.
- Signing of written informed consent.
Exclusion Criteria:
- History or presence of systemic arterial hypertension (treated or not)
- History or presence of ischemic heart disease and peripheral vascular disease.
- Presence of greater than mild valvular disease.
- Patients who have a different rhythm in the baseline electrocardiogram, other than sinus (atrial fibrillation, atrial flutter, junctional rhythm).
- Presence of severe anemia (Hb <7 g / dL).
- Presence of shock, hepatic encephalopathy, bacterial infection or bleeding at inclusion or during the previous week.
- History or presence of severe or decompensated lung disease.
- Presence of percutaneous intrahepatic porto-systemic shunt (TIPS).
- Pregnancy.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Child A liver cirrhosis
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Child B liver cirrhosis
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Child C liver cirrhosis
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Adverse events as defined as composite of death due to liver failure, gastrointestinal bleeding, spontaneous bacterial peritonitis or need to conduct liver transplant in patients with liver cirrhosis.
Zeitfenster: 12 months follow-up
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Identify the occurrence of adverse events as defined as:
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12 months follow-up
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Angelo A Salgado, Master, Rio de Janeiro State University
- Studienstuhl: Carlos Terra, PHD, Rio de Janeiro State University
- Studienstuhl: Márcia B Castier, PHD, Rio de Janeiro State University
- Studienstuhl: Paulo R Benchimol-Barbosa, DSC, Rio de Janeiro State University
- Hauptermittler: Camila SS Reis, MD, Universidade de Estado do Rio de Janeiro
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- arquivo1
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