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An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.

2018-12-20 04:52:16 | BioPortfolio

Summary

The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study (AC-055H301, NCT03153137). This OL trial studies the long-term effect of macitentan in Fontan-palliated patients as it is not known if the effect of macitentan is sustained beyond 52 weeks (end of the parent RUBATO DB study). In addition, the trial also studies the long-term safety of macitentan as this is also unknown. Furthermore, the opportunity will be given to patients who were on placebo in the parent RUBATO DB study to receive macitentan 10 mg and benefit from a potentially active treatment.

Study Design

Conditions

Congenital Heart Disease With Fontan Circulation

Intervention

macitentan 10 mg

Status

Not yet recruiting

Source

Actelion

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-12-20T04:52:16-0500

Clinical Trials [2642 Associated Clinical Trials listed on BioPortfolio]

Fontan Circulation and Cardiopulmonary Function: Prognostic Factors, Hemodynamics and Long-term Effects

Cross-sectional study of a national cohort of adolescents with univentricular congenital heart defects and Fontan type palliation.

Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects.

Clinical study assessing the efficacy and safety of macitentan in Fontan-palliated subjects.

Colloid Osmotic Pressure in Patients With Fontan Circulation

Children born with univentricular heart will go through step surgery and end up with a Fontan circulation. A circulation with cause problems with body fluid balance.This project will evalu...

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This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predi...

Metabolic Remodeling in Fontan Patients

Assessment of metabolic alterations in adult Fontan patients with a dominant left ventricle with the help of serum examinations (Metabolomics). The aim is to find a tool for the completion...

PubMed Articles [20470 Associated PubMed Articles listed on BioPortfolio]

Progressive loss of bone mass in children with Fontan circulation.

We investigated bone mineral density (BMD) at different ages after the Fontan completion, and we evaluated the relationship between BMD, vitamin D levels, and pertinent patient variables.

Fontan-associated liver disease: pathophysiology, investigations, predictors of severity and management.

Cardiac hepatopathy is the liver injury resulting from congestion and ischaemia associated with acute or chronic heart failure. The improved longevity of adults with operated congenital heart disease ...

Relation Between Exercise Capacity and Extracardiac Conduit Size in Patients with Fontan Circulation.

Because Fontan circulation does not have a subpulmonary ventricle, the preload is limited. In Fontan circulation with extracardiac conduit, the size of conduit could be an important factor in determin...

Prevalence, features and predictive factors of liver nodules in Fontan surgery patients: The VALDIG Fonliver prospective cohort.

Fontan surgery is used to treat a variety of congenital heart malformations, and may lead to advanced chronic liver disease in the long-term. This study examines the prevalence, characteristics and pr...

Flow Profile Characteristics in Fontan Circulation are Associated with the Single Ventricle Dilation and Function: Principal Component Analysis Study.

The Fontan circulation is characterized as a non-pulsatile flow propagation without a pressure generating ventricle. However, flow through the Fontan circulation still exhibits oscillatory waves as a ...

Medical and Biotech [MESH] Definitions

A set of surgical procedures performed to establish sufficient outflow to the systemic circulation in individuals with univentricular congenital heart malformations, such as HYPOPLASTIC LEFT HEART SYNDROME, and MITRAL VALVE atresia, associated with systemic outflow obstruction. Follow-on surgeries may be performed and consist of a HEMI-FONTAN PROCEDURE as the stage 2 Norwood procedure and a FONTAN PROCEDURE as the stage 3 Norwood procedure.

A congenital cardiovascular malformation in which the AORTA arises entirely from the RIGHT VENTRICLE, and the PULMONARY ARTERY from the LEFT VENTRICLE. Consequently, the pulmonary and the systemic circulations are parallel and not sequential, so that the venous return from the peripheral circulation is re-circulated by the right ventricle via aorta to the systemic circulation without being oxygenated in the lungs. This is a potentially lethal form of heart disease in newborns and infants.

Rhythmic compression of the heart by pressure applied manually over the sternum (closed heart massage) or directly to the heart through an opening in the chest wall (open heart massage). It is done to reinstate and maintain circulation. (Dorland, 28th ed)

Cessation of heart beat or MYOCARDIAL CONTRACTION. If it is treated within a few minutes, heart arrest can be reversed in most cases to normal cardiac rhythm and effective circulation.

Cardiac manifestation of systemic rheumatological conditions, such as RHEUMATIC FEVER. Rheumatic heart disease can involve any part the heart, most often the HEART VALVES and the ENDOCARDIUM.

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Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


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