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Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01447550
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Joaquin de Haro, M.D., Hospital Universitario Getafe

Study Description
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Brief Summary:

This study assessed the effectiveness and safety of bosentan when administered to thromboangiitis obliterans (Buerger's disease)patients. A clinical pilot study was designed,included in which patients with ulcer and/or pain at rest were treated with bosentan p.o at a dose of 62,5 mg twice daily during the first month, which each thereafter uptitrated to 125 mg twice daily. Study endpoints were clinical improvement rate, major or minor amputation rate, hemodynamic changes, changes in endothelial function and angiographic changes.

12 patients were included were current smokers. With bosentan treatment, no new ischemic lesions were observed in all but one patient. Overall, clinical improvement was observed in 12 of the 13 extremities (92%). Only two of 13 extremities underwent amputation after bosentan treatment. As assessed by digital arteriography with subtraction or angio-magnetic resonance image an increase of distal flow was observed in 10 out of the 12 patients. All patients experienced a statistically significant improvement in their BAFMD values (means:1.8 at baseline;6.6 at the end of the treatment;12.7 three months after the end of the treatment;p<0.01). In conclusion: Bosentan treatment may result in an improvement of clinical, angiographic, hemodynamic and endothelial function outcome. Bosentan deserves further investigation in the management TAO patients.


Condition or disease Intervention/treatment
Thromboangiitis Obliterans Drug: Bosentan

Study Design
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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Thromboangiitis Obliterans (Buerger's Disease) With Bosentan
Study Start Date : January 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bosentan

Groups and Cohorts
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Group/Cohort Intervention/treatment
Bosentan
Bosentan
 Drug: Bosentan
Bosentan therapy consisted of a month's treatment with 62.5 mg bid orally administered. Dose doubled to 125 mg bid after the first month. The full-dose regimen (125 mg/12h) was maintained for the following months or until total healing fo the ulcers.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical improvement rate [ Time Frame: 4-6 months ]
    Clinical improvement rate (absence of new throphic lesions, ulcer healing process, pain relief, complete absence of pain), major of minor amputation rate

  2. Clinical improvement rate [ Time Frame: 4-6 months ]
    Clinical improvement rate (abscence of new throphic lesions, ulcer healing process, pain relief, complete absence of pain), major of minor amputation rate

  3. Clinical improvement rate [ Time Frame: 4-6 months ]
    Clinical improvement rate (absence of new throphic lesions, ulcer healing process, pain relief, complete absense of pain), major of minor amputation rate


Secondary Outcome Measures :
  1. haemodynamics, endothelial function and angiographic changes [ Time Frame: 4-6 months ]
    Hemodynamic changes as measured by means of ABI, changes in endothelial funtion as measured by means of the brachial artery flow-mediated dilation test (BAFMD) and angiographic changes as measured by means of arteriography with digital substraction or an angio-magnetic resonance image (MRI).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from Buerger's disease
Criteria

Inclusion Criteria:

  • Critical ischemia in any extremity, causing pain at rest or non-healing ischemic ulcers, present for at least four weeks with no evidence of improvement in response to conventional treatment.

Exclusion Criteria:

  • Being candidates for surgical or endovascular revascularisation of the extremity studied.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01447550


Locations
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Spain
Hospital Universitario Getafe
Getafe, Madrid, Spain, 28905
Hospital Universitario de Getafe
Getafe, Spain, 28901
Sponsors and Collaborators
Hospital Universitario Getafe
Investigators
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Principal Investigator: Joaquin De Haro, MD,PhD Hospital Universitario de Getafe
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Joaquin de Haro, M.D., Treatment of thromboangiitis obliterans (Buergueer´s disease) with Bosentan, Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT01447550    
Other Study ID Numbers: Buerger-Bosentan
First Posted: October 6, 2011    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Keywords provided by Joaquin de Haro, M.D., Hospital Universitario Getafe:
Bosentan
Buerguer disease
Additional relevant MeSH terms:
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Thromboangiitis Obliterans
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis
 Bosentan
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action