Status:
UNKNOWN
Beta-blockers in i-PAH
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Idiopathic Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The main question of this study is: 'Is selective beta-blocker treatment safe and effective in reducing sympathetic overdrive, thereby improving RV function and remodeling in patients with iPAH?'. In...
Detailed Description
This is a clinical study aimed to provide a proof of concept of the safety and efficacy of beta-blocker treatment in PAH-associated right ventricular failure. The protocol of the proposed double blin...
Eligibility Criteria
Inclusion
- Idiopathic PAH patients
- Stable on PAH specific treatment defined
- No change in PAH specific treatment in the past 6 months
- No change in functional class in the past 6 months
- \<10 % change in 6 minute walk distance in the past 6 months
- Functional class 2 or 3
- In sinus rhythm
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01246037
Start Date
February 1 2011
End Date
April 1 2014
Last Update
January 14 2014
Active Locations (1)
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1
VUmc
Amsterdam, Netherlands