Andorfer, Kornelia E. C. and Seebauer, C. T. and Koller, M. and Zeman, F. and Berneburg, M. and Fischer, R. and Vielsmeier, V. and Bohr, C. and Kuehnel, T. S. (2022) TIMolol nasal spray as a treatment for epistaxis in hereditary hemorrhagic telangiectasia (HHT) - Study protocol of the prospective, randomized, double-blind, controlled cross-over TIM-HHT trial. CLINICAL HEMORHEOLOGY AND MICROCIRCULATION, 80 (3). pp. 307-315. ISSN 1386-0291, 1875-8622
Full text not available from this repository. (Request a copy)Abstract
BACKGROUND: Hereditary hemorrhagic telangiectasia (HHT) is an inherited orphan disease, in which the absence of capillary beds between arterioles and venules lead to arteriovenous shunts. Epistaxis is the core symptom. Several case reports have described the nonselective beta-adrenergic receptor antagonist timolol as a successful treatment method of nosebleeds due in HHT patients. OBJECTIVE: TIM-HHT is a single-site, prospective, randomized, placebo-controlled, double-blind, cross-over study to investigate whether the efficacy of standard laser treatment of epistaxis in HHT patients can be increased by the additional use of timolol nasal spray (1 mg/d). METHODS: Twenty patients will be randomly allocated to one of two treatment sequences. Primary outcome is the severity of epistaxis determined by the Epistaxis Severity Score (ESS). Secondary outcomes are subjective satisfaction, quality of life, as well as the hemoglobin, ferritin, and transferrin levels of the participating patients. Safety outcome is assessed by means of pulse, blood pressure, and adverse events. CONCLUSION: TIM-HHT will evaluate the efficacy and safety of timolol as an additional treatment of epistaxis in HHT patients in a three-month trial period. Benzalkonium chloride is used as a placebo, which has no documented positive effect on the nasal mucosa and hence on epistaxis in HHT patients (in contrast to saline).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PROPRANOLOL; FREQUENCY; SEVERITY; Timolol; nasal sprays; HHT; hereditary hemorrhagic telangiectasia; Osler; rare disease; epistaxis |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Dermatologie und Venerologie Medicine > Lehrstuhl für Hals-Nasen-Ohren-Heilkunde Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 12 Feb 2024 11:23 |
| Last Modified: | 12 Feb 2024 11:23 |
| URI: | https://pred.uni-regensburg.de/id/eprint/56556 |
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