Betablocker Therapy in Pulmonary Arterial Hypertensio
- Conditions
- Idiopathic pulmonal arterial hypertensionMedDRA 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
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 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
Name Time Method
- Secondary Outcome Measures
Name Time Method