Clinical trial NCT01447550: Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan
Official title: Treatment of Thromboangiitis Obliterans (Buerger's Disease) With Bosentan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboangiitis Obliterans
Keywords: Bosentan
Buerguer disease
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from Buerger's disease

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.


Eligibility 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.

Primary outcomes:
measure: Clinical improvement rate
timeFrame: 4-6 months
measure: Clinical improvement rate
timeFrame: 4-6 months
measure: Clinical improvement rate
timeFrame: 4-6 months
Secondary outcomes:
measure: haemodynamics, endothelial function and angiographic changes
timeFrame: 4-6 months
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Hospital Universitario Getafe
state: Madrid
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
Study officials:
affiliation: Hospital Universitario de Getafe
name: Joaquin De Haro, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.