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

NCT01447550 | Completed DMC

• 1 other identifier: Buerger-Bosentan
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

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.

Conditions

Thromboangiitis Obliterans

Keywords

Bosentan; Buerguer disease

Outcome Measures

Primary Outcomes (3)

• Clinical improvement rate

  Clinical improvement rate (absence of new throphic lesions, ulcer healing process, pain relief, complete absence of pain), major of minor amputation rate

  4-6 months

• Clinical improvement rate

  Clinical improvement rate (abscence of new throphic lesions, ulcer healing process, pain relief, complete absence of pain), major of minor amputation rate

  4-6 months

• Clinical improvement rate

  Clinical improvement rate (absence of new throphic lesions, ulcer healing process, pain relief, complete absense of pain), major of minor amputation rate

  4-6 months

Secondary Outcomes (1)

• haemodynamics, endothelial function and angiographic changes

  4-6 months

Study Arms (1)

Bosentan

Bosentan

Drug: Bosentan

Interventions

Bosentan DRUG

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.

Bosentan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from Buerger's disease

You may qualify if:

• 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.

You may not qualify if:

• Being candidates for surgical or endovascular revascularisation of the extremity studied.

Sponsors & Collaborators

• Hospital Universitario Getafe: lead

Study Sites (2)

Hospital Universitario de Getafe

Getafe, Getafe, 28901, Spain

Location

Hospital Universitario Getafe

Getafe, Madrid, 28905, Spain

Location

Related Publications (2)

• De Haro J, Bleda S, Acin F. An open-label study on long-term outcomes of bosentan for treating ulcers in thromboangiitis obliterans (Buerger's disease). Int J Cardiol. 2014 Dec 15;177(2):529-31. doi: 10.1016/j.ijcard.2014.08.107. Epub 2014 Aug 23. No abstract available.

  PMID: 25217217 DERIVED

• De Haro J, Acin F, Bleda S, Varela C, Esparza L. Treatment of thromboangiitis obliterans (Buerger's disease) with bosentan. BMC Cardiovasc Disord. 2012 Feb 14;12:5. doi: 10.1186/1471-2261-12-5.

  PMID: 22333218 DERIVED

MeSH Terms

Conditions

Thromboangiitis Obliterans

Interventions

Bosentan

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Joaquin De Haro, MD,PhD

  Hospital Universitario de Getafe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Treatment of thromboangiitis obliterans (Buergueer´s disease) with Bosentan

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: October 6, 2011
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

ES (2)