- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01842867
Syndecan-4 as a Biomarker in Patients With Chagas Disease
Validation of Syndecan-4 as a Biomarker for Determining Patients Prognosis With Chagas Disease.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Increased serum levels of syndecan-4 have been correlated to acute myocardial infarction and chronic heart failure, suggesting that this molecule can be an important biomarker in heart diseases. In spite of that, there are no studies that have investigated the role of this molecule in chronic chagasic cardiomyopathy yet.
In this project, our objective is to demonstrate the potential role of syndecan-4 in the prognosis of chronic chagasic cardiomyopathy, seeking a better fitting of the treatment through the identification of patients with the worse prognosis.
The patients included in the study must at first sign the written consent. They shall be accompanied in the specialized outpatient clinics for Chagas disease - Hospital São Rafael - Centro de Biotecnologia e Terapia Celular. They will be submitted to several tests, including:
- Collection of Blood samples for biochemical analysis;
- Electrocardiogram;
- Holter Electrocardiogram;
- Echocardiogram;
- Treadmill Test;
- X-Ray Imaging;
- Magnetic Resonance Imaging;
- Evaluation of the quality of life through the application of questionnaires (SF 36 and the Minnesota Living With Heart Failure Questionnaire).
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
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Bahia
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Salvador, Bahia, Brasil, 41253-190
- Hospital Sao Rafael
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Chagas disease diagnosis confirmed by 2 different serologies
- Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction.
Exclusion Criteria:
- Significant valve disease defined as aortic stenosis with a gradient of VE/Ao > 50 mmHg
- Mitral stenosis with a valve area inferior than 1,5 cm2
- Superior or moderated aortic and/or mitral regurgitation
- Chronic use of immunosuppressive agents
- Dialysis treatment of terminal renal failure
- Fever on the last 48 hours or evidence of systemic infection in activity according to the definition of sepsis of the ACCP/SCCM (American College os Chest Physicians/Society of Critical Care Medicine)
- Current abusive use of alcohol or illicit drugs (Based on the DSM IV)
- Any other comorbidities that impact patient's survival within the next 2 years
- Liver disease in activity
- Continuous use of steroids as treatment for COPD
- Hematologic, neoplastic or bone diseases
- Homeostasis disturbances
- Inflammatory diseases or chronic infectious diseases
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
Pasienter med diagnosen Chagas sykdom
Diagnose av Chagas sykdom i begge former: ubestemte og hjertesykdom, med og uten ventrikulær dysfunksjon.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Correlation of plasmatic levels of syndecan-4 with the percentage of heart fibrosis
Tidsramme: One year
|
Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging
|
One year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Correlation of plasmatic levels of syndecan-4 with the functional cardiovascular capacity
Tidsramme: One year
|
Mensuration of the functional capacity with treadmill test.
|
One year
|
Correlation of plasmatic levels of Syndecan-4 with the left ventricular function
Tidsramme: One year
|
Mensuration of the left ventricular function with echocardiogram and magnetic resonance imaging
|
One year
|
Correlation of plasmatic levels of Syndecan-4 with the serum levels of Pro-BNP.
Tidsramme: One year
|
One year
|
|
Correlation of plasmatic levels of Syndecan-4 with the serum levels of TNF-alpha
Tidsramme: One year
|
One year
|
|
Correlation of plasmatic levels of Syndecan-4 with the serum levels of IFN-gamma.
Tidsramme: One year
|
One year
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Milena Botelho Pereira Soares, PhD, Hospital Sao Rafael
- Studiestol: Carolina Thé Macedo, MD, Hospital Sao Rafael
- Studieleder: Ricardo Ribeiro dos Santos, MD, Hospital Sao Rafael
- Studiestol: Ticiana Ferreira Larocca, MD, Hospital Sao Rafael
- Studiestol: Márcia Maria Noya Rabelo, MD, Hospital Sao Rafael
- Studiestol: Luís Cláudio Lemos Correia, MD, Hospital Sao Rafael
- Studiestol: Bruno Solano de Freitas Souza, MD, Hospital Sao Rafael
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CEP-41-10-1
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