An observational study in Eisenmenger Complex, sponsored by Samsung Medical Center. Status unknown. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Samsung Medical Center · Observational
In this study, the investigator will evaluate the treatment effects and safety, patient compliance of Ambrisentan in Eisenmenger syndrome in PAH patients who have been previously treated with Bosentan.
Endothelin receptor antagonist is an established class of targeted therapy for pulmonary arterial hypertension (PAH). Nonselective ERA, Bosentan was the first approved ERA for PAH. Selective ERA, Ambrisentan was also approved for PAH treatment consequently. Although non-selective and selective ERA are both effective in clinical trials, there is no direct comparison for non-selective and selective ERA. Furthermore, approval study for both non-selective and selective ERA did not include the PAH associated with congenital heart disease (PAH-CHD) with significant shunt including Eisenmenger syndrome. Approval study for Ambrisentan;ARIES-1 and ARIES-2 trials also did not include the PAH-CHD In Korea, Bosentan was approved in 2003 and Ambrisentan was approved in 2009 for idiopathic PAH. Bosentan was also approved for PAH-CHD, however, Amrisentan was not because of limited data for PAH-CHD. Therefore, Bosentan was the only ERA covered by public health insurance since 2018 for PAH-CHD. Recently, Amrisentan was also approved for PAH associated with congenital heart disease including Eisenmger syndrome. And, there is a need for changing medication from double pill medication to once-daily dose medication because of patient's compliance.
PAH associated with CHD includes the group with significant shunt vs without shunt (s/p corrected state). When there is a shunt flow, change in pulmonary vascular resistance (PVR) and cardiac output can be a modulator of shunt flow, thus impact of pulmonary vasodilator on hemodynamics can be different from PAH without shunt. However, there is a limited data for changing ERA from non-selective to selective ERA. Our patients population can be interesting study group to understand the clinical response to changing between ERA because they are uniformly treated with non-selective ERA to selective ERA, Bosentan to Ambrisentan.
In this study, the investigators will evaluate the treatment effects and safety, patient compliance of Ambrisentan in Eisenmenger syndrome in PAH patients who have been previously treated with Bosentan.
23 studies on the registry are indexed under Eisenmenger Complex; 5 are open to participants now.
Browse Eisenmenger Complex studies →Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age at least 18 years
One of the following diagnosis:
i) non-corrected large congenital shunting defect at atrial, ventricular or arterial level: Partial anomalous venous return, atrial septal defect, ventricular septal defect, atrioventricular cushion defect, persistent ductus arteriosus, or a combination of these.
ii) Surgically corrected shunting defect (diagnoses as above) with significant residual defect iii) Other diagnoses with univentricular physiology/haemodynamics.
pregnancy or lactation
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Change of WHO FC
WHO functional class I, II, III, IV.
Time frame: change from baseline to 6 months
Changes in Borg dyspnea scale
scale 0 -10
Time frame: change from baseline to 6 months
TAPSE (TTE measure)
mm pericardial effusion(presence, absence), RA size(mm), RV strain(%)
Time frame: change from baseline to 6 months
pericardial effusion (TTE measure)
presence, or absence
Time frame: change from baseline to 6 months
RA size (TTE measure)
mm
Time frame: change from baseline to 6 months
RV strain(TTE measure)
Time frame: change from baseline to 6 months
6-minute walk distances (6MWT)
m
Time frame: change from baseline to 6 months
blood pressure at rest (SBP and DBP)
mmHg
Time frame: change from baseline to 6 months
adverse drug response
any adverse drug response
Time frame: baseline, 12 week, 24 week, till 6 months if available.
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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