- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01184404
Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery (BOCA)
Panoramica dello studio
Descrizione dettagliata
Rationale: Cardiac surgery relieves symptoms and increases life expectancy in cardiac patients, with and without congenital heart disease (CHD). However, cardiac surgery involves many risks of complications, such as bleeding, arrhythmias, and death. Right ventricular failure is another complication, contributing to poor clinical outcome. This clinical syndrome is often difficult to treat and is characterized by edema, elevated jugular venous pressure, oliguria, hypotension, and in severe cases shock, multi organ failure and death.
Patients at increased risk for developing post operative right ventricular failure are those with CHD or with mitral valve lesions, because of their elevated afterload. Other clinical factors contributing to right ventricular failure are mechanical pulmonary ventilation, pre-existing pulmonary hypertension and cardiac surgery. Right ventricular failure due to cardiac surgery is caused by the cardiopulmonary bypass, by reperfusion with high partial pressures of oxygen, air embolism, and the release of cytokines. The endothelin-1 cytokine release during cardiac surgery induces vasoconstriction of the pulmonary arterioles resulting in right ventricular afterload elevation. Therefore, we hypothesize that treating patients with an endothelin-1 receptor antagonist will improve clinical outcome, measured by aerobic capacity (peak V'O2), by decreasing right ventricular afterload peri-operatively.
Objective: To investigate whether an endothelin-1 receptor antagonist improves aerobic capacity (peak V'O2) in adults with CHD or with mitral valve lesions who undergo cardiac surgery.
Study design: A prospective randomized open label assessment with blinded end-points (PROBE-design). Total duration of the study is 18 weeks with 6 weeks pre-operative and 12 weeks post-operative treatment with bosentan.
Study population: Adults with CHD who undergo cardiac surgery and patients undergoing mitral valve surgery in the Academic Medical Centre in Amsterdam. Patients will be randomized six weeks before surgery. The study will continue until 12 weeks postoperatively.
Intervention: The treatment group receives a starting dose of 62.5 mg tablet bosentan twice daily for four weeks followed by 125 mg tablet of bosentan twice daily two weeks prior to and 12 weeks after surgery. The other group receives no study medication.
Main study parameters/endpoints: 1) on the intensive care unit a) hemodynamics b)Sequential Organ Failure Assessment (SOFA) score and c) hours of hospitalization 2) at discharge the right ventricular function (assessed by transthoracic echocardiography) 3) six weeks post-operatively a) clinical condition with exercise capacity (peak V'O2) b) right ventricular function (assessed by transthoracic echocardiography) c) the quality of life 4) twelve weeks post-operatively a) right ventricular function (assessed by transthoracic echocardiography) b) differences in clinical status and symptoms
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Mark Schuuring, MD
- Numero di telefono: 31205668687
- Email: m.j.schuuring@amc.uva.nl
Luoghi di studio
-
-
NH
-
Amsterdam, NH, Olanda, 1105AZ
- Reclutamento
- Academic Medical Center
-
Contatto:
- Mark Schuuring, MD
- Numero di telefono: 31205668687
- Email: m.j.schuuring@amc.uva.nl
-
Investigatore principale:
- B J Bouma, MD PhD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Adults with CHD or mitral valve lesions who are scheduled for elective cardiac surgery
Exclusion Criteria:
- Current treatment with bosentan
- Systemic arterial pressure < 85 mmHg
- Incapable of giving informed consent
- Hypersensitivity to bosentan or any of its help substances
- Moderate to severe liver disease: Child-Pugh class B or C
- Raised plasma transaminases level > three times limiting value.
- Simultaneous use of cyclosporine A
- Percutaneous Transluminal Angioplasty procedures
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Controllo
|
|
Sperimentale: Treatment
The treatment group receives a starting dose of 62.5 mg tablet bosentan twice daily for four weeks followed by 125 mg tablet of bosentan twice daily two weeks prior to and 12 weeks after surgery.
|
The treatment group receives a starting dose of 62.5 mg tablet bosentan twice daily for four weeks followed by 125 mg tablet of bosentan twice daily two weeks prior to and 12 weeks after surgery.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
peak V'O2
Lasso di tempo: 18 weeks
|
The primary objective of this study is to determine changes in aerobic capacity (peak V'O2)in adult CHD patients or with mitral valve lesions who undergo surgery comparing treated with non-treated patients.
|
18 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Right ventricular function
Lasso di tempo: 18 weeks
|
To determine 18 weeks after baseline differences in right ventricular function (assessed by transthoracic echocardiography)
|
18 weeks
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 03603
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Cardiopatia congenita
-
Region SkaneIscrizione su invitoInsufficienza cardiaca Classe II della New York Heart Association (NYHA). | Insufficienza cardiaca Classe III della New York Heart Association (NYHA).Svezia
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... e altri collaboratoriNon ancora reclutamentoInsufficienza cardiaca, sistolica | Insufficienza cardiaca con frazione di eiezione ridotta | Scompenso cardiaco Classe IV della New York Heart Association | Scompenso cardiaco Classe III della New York Heart AssociationPolonia
-
University of WashingtonAmerican Heart AssociationCompletatoInsufficienza cardiaca, congestizia | Alterazione mitocondriale | Scompenso cardiaco Classe IV della New York Heart AssociationStati Uniti
Prove cliniche su Bosentan
-
ActelionCompletatoUlcere digitaliFrancia, Regno Unito, Stati Uniti, Austria, Canada, Germania, Italia, Svizzera
-
GeropharmCompletato
-
ActelionCompletatoSclerosi sistemica | Ulcere digitaliStati Uniti, Canada
-
Medical University of ViennaCompletatoGlaucoma | Velocità del flusso sanguignoAustria
-
ActelionCompletatoMalattia polmonare interstiziale | SclerodermiaStati Uniti, Corea, Repubblica di, Israele, Francia, Regno Unito, Olanda, Svizzera, Germania, Canada, Italia, Svezia
-
Rikshospitalet University HospitalTerminatoSclerosi sistemica (Sclerodermia)Norvegia
-
ActelionCompletatoIpertensione arteriosa polmonare correlata alla fisiologia di EisenmengerCanada, Regno Unito, Italia, Stati Uniti, Olanda, Australia, Austria, Belgio, Francia, Germania, Spagna
-
University Hospital, GrenobleReclutamentoNeuropatia ottica ischemicaFrancia
-
Daniel DobererTerminatoIpertensione polmonare | SarcoidosiAustria