Beta-blockers in i-PAH

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01246037
• Date of registration: 18/11/2010
• Prospective Registration: Yes
• Primary sponsor: VU University Medical Center
• Public title: Beta-blockers in i-PAH
• Scientific title: Beta-blocker Therapy in Idiopathic Pulmonary Arterial Hypertension
• Date of first enrolment: February 2011
• Target sample size: 30
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01246037
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: Anton Vonk Noordegraaf, Prof. MD PhD
• Affiliation: VU University Medical Center, pulmonary department

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Arterial Hypertension

Intervention(s)

Drug: Bisoprolol

Primary Outcome(s)

Effectivity [Time Frame: 6 months]

Safety [Time Frame: continue]

Secondary Outcome(s)

Is Bisoprolol effective in reversing maladaptive remodeling of the right ventricular wall, and does Bisoprolol thereby improve the diastolic properties of the right ventricle? [Time Frame: 0,6 and 12 months]

Is Bisoprolol effective in improving exercise capacity? [Time Frame: Every two weeks]

Is Bisoprolol treatment effective in improving the perfusion and mechanical efficiency (oxygen consumption per joule) of the heart? [Time Frame: 0,6,12 months]

Is Bisoprolol treatment effective in reducing sympathetic overdrive? [Time Frame: 0,6,12 months]

Secondary ID(s)

2010-262

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

ZonMw: The Netherlands Organisation for Health Research and Development