Beta-blockers in i-PAH
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ClinicalTrials.gov Identifier: NCT01246037 |
Recruitment Status : Unknown
Verified January 2014 by A. Vonk Noordegraaf, Amsterdam UMC, location VUmc.
Recruitment status was: Active, not recruiting
First Posted : November 23, 2010
Last Update Posted : January 14, 2014
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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 addition to the determination of RVEF, the investigators will explore how beta-blocker therapy affects sympathetic overdrive, remodeling of the RV, single beat elastance, exercise capacity and mechanical efficiency.
30 iPAH patients will be randomized to either Bisoprolol- or placebo-treatment in a double-blinded fashion. A cross-over trial design will be used to increase the power of the study and to assess long-term effects of Bisoprolol-treatment and -withdrawal. The medication will be given in an escalating dose regimen (as described in the 'farmacotherapeutisch kompas', www.fk.cvz.nl) and treatment will be monitored along the guidelines of the American Heart Association.
Condition or disease | Intervention/treatment | Phase |
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Idiopathic Pulmonary Arterial Hypertension | Drug: Bisoprolol | Phase 1 Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Beta-blocker Therapy in Idiopathic Pulmonary Arterial Hypertension |
Study Start Date : | February 2011 |
Actual Primary Completion Date : | January 2014 |
Estimated Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
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Experimental: First placebo
First half year placebo, second half year bisoprolol
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Drug: Bisoprolol
In the first 4 months of study, the dose of the drug will be gradually increased; the titration scheme is based on the 'farmacotherapeutisch kompas' and monitored according to the ACC/AHA/ESC guidelines. Up titration will be performed under the responsibilities of an experienced heart failure cardiologist and pulmonologist. |
Experimental: First Bisoprolol
First half year bisoprolol, second half year placebo
|
Drug: Bisoprolol
In the first 4 months of study, the dose of the drug will be gradually increased; the titration scheme is based on the 'farmacotherapeutisch kompas' and monitored according to the ACC/AHA/ESC guidelines. Up titration will be performed under the responsibilities of an experienced heart failure cardiologist and pulmonologist. |
- Effectivity [ Time Frame: 6 months ]The primary efficacy endpoint is improvement in RV function as reflected by RVEF determined by means of cardiac MRI.
- Safety [ Time Frame: continue ]Safety of Bisoprolol treatment in iPAH patients is not taken as a primary endpoint but seen as a precondition for this study and will be closely monitored. Dose titration will be guided by possible side effects.
- Is Bisoprolol treatment effective in reducing sympathetic overdrive? [ Time Frame: 0,6,12 months ]Herefore the investigators use a C11-Hed-, H2O15- and a C11-acetate- nuclear scan
- 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 ]Pressure-Volume loops will be reconstructed from the combined right heart catheterization data and MRI measurements
- Is Bisoprolol treatment effective in improving the perfusion and mechanical efficiency (oxygen consumption per joule) of the heart? [ Time Frame: 0,6,12 months ]Perfusion will be measured by using the H2O tracer. Oxygen consumption of the right ventricle will be estimated from the uptake of the acetate tracer. Right ventricular power output will be derived from the right heart catheterization data.
- Is Bisoprolol effective in improving exercise capacity? [ Time Frame: Every two weeks ]This will be measured by means of the maximal oxygen uptake which is measured by means of the incremental cardiopulmonary exercise test and six minute walking distance.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Idiopathic PAH patients
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246037
Netherlands | |
VUmc | |
Amsterdam, Netherlands |
Principal Investigator: | Anton Vonk Noordegraaf, Prof. MD PhD | VU University Medical Center, pulmonary department |
Responsible Party: | A. Vonk Noordegraaf, Prof. dr., Amsterdam UMC, location VUmc |
ClinicalTrials.gov Identifier: | NCT01246037 |
Other Study ID Numbers: |
2010-262 |
First Posted: | November 23, 2010 Key Record Dates |
Last Update Posted: | January 14, 2014 |
Last Verified: | January 2014 |
Pulmonary Arterial Hypertension Beta-blocker Adrenergic Receptor Antagonist |
Pulmonary Arterial Hypertension Familial Primary Pulmonary Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Bisoprolol Antihypertensive Agents |
Sympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |