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Betablocker Therapy in Pulmonary Arterial Hypertensio

Conditions
Idiopathic pulmonal arterial hypertension
MedDRA version: 12.1Level: LLTClassification code 10020787Term: Hypertension pulmonary
Registration Number
EUCTR2010-020424-21-NL
Lead Sponsor
VU medical center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Population:
The VUMC serves as a national tertiary referral centre for the diagnosis and treatment of PAH and had 1500 referrals in 10 years. Currently more than 100 idiopathic PAH patients are treated in the VUMC, which make it possible to select our study population with care from this large cohort.
We choose to limit our study to idiopathic PAH patients, since this is a well-characterized homogenous group with little or no co-morbidities. It is estimated that the current prevalence of iPAH in the Netherlands is about 200 patients. However, if our results turn out to be positive this might have an important impact on the management of other more common types of pulmonary hypertension.

Inclusion criteria
From our database containing currently 156 PAH patients we will carefully select patients who meet the following inclusion criteria:
•Idiopathic PAH patients
•Stable on PAH specific treatment defined
oNo change in PAH specific treatment in the past 6 months
oNo change in functional class in the past 6 months
o<10 % change in 6 minute walk distance in the past 6 months
•Functional class 2 or 3
•In sinus rhythm

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria are
•History of systemic hypertension, ischaemic heart disease, valvular disease or cardiomyopathy.
•Asthma
•Use of concomitant medication other than diuretics, Acenocoumarol and PAH targeted therapy
•History of cardiac arrhythmias or the use of anti-arrhythmic drugs
•Sick sinus syndrome
•systolic hypotension < 90 mmHg
•AV-block
•Clinically relevant sinus-bradycardia.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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