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Beta-blockers in i-PAH
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by A. Vonk Noordegraaf, VU University Medical Center.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
VU University Medical Center
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
A. Vonk Noordegraaf, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01246037
First received: November 18, 2010
Last updated: January 13, 2014
Last verified: January 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Idiopathic Pulmonary Arterial Hypertension | Drug: Bisoprolol | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Beta-blocker Therapy in Idiopathic Pulmonary Arterial Hypertension |
Resource links provided by NLM:
Further study details as provided by A. Vonk Noordegraaf, VU University Medical Center:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | April 2014 |
| Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: First placebo
First half year placebo, second half year bisoprolol
|
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.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246037
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246037
Locations
| Netherlands | |
| VUmc | |
| Amsterdam, Netherlands | |
Sponsors and Collaborators
VU University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
| Principal Investigator: | Anton Vonk Noordegraaf, Prof. MD PhD | VU University Medical Center, pulmonary department |
More Information
| Responsible Party: | A. Vonk Noordegraaf, Prof. dr., VU University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01246037 History of Changes |
| Other Study ID Numbers: |
2010-262 |
| Study First Received: | November 18, 2010 |
| Last Updated: | January 13, 2014 |
Keywords provided by A. Vonk Noordegraaf, VU University Medical Center:
|
Pulmonary Arterial Hypertension Beta-blocker Adrenergic Receptor Antagonist |
Additional relevant MeSH terms:
|
Hypertension Familial Primary Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Adrenergic beta-Antagonists Bisoprolol Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antihypertensive Agents Sympatholytics Autonomic Agents Peripheral Nervous System Agents Adrenergic beta-1 Receptor Antagonists |
ClinicalTrials.gov processed this record on July 19, 2017