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

URN to cite this document:

urn:nbn:de:bvb:355-epub-514619 Copy

DOI to cite this document:

10.5283/epub.51461 Copy

Andorfer, Kornelia E.C. ; Seebauer, Caroline T. ; Koller, Michael ; Zeman, Florian ; Berneburg, Mark ; Fischer, René ; Vielsmeier, Veronika ; Bohr, Christopher ; Kühnel, Thomas S.

Date of publication of this fulltext: 17 Jul 2023 16:26

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Details

Item type:	Article
Open Access Type:	No Open Access
Journal or Publication Title:	Clinical Hemorheology and Microcirculation
Publisher:	IOS PRESS
Place of Publication:	AMSTERDAM
Volume:	80
Number of Issue or Book Chapter:	3
Page Range:	pp. 307-315
Date:	9 March 2022
Institutions:	Medicine > Lehrstuhl für Dermatologie und Venerologie Medicine > Lehrstuhl für Hals-Nasen-Ohren-Heilkunde Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien
Identification Number:	Value Type 10.3233/CH-211253 DOI
Keywords:	PROPRANOLOL; FREQUENCY; SEVERITY; Timolol; nasal sprays; HHT; hereditary hemorrhagic telangiectasia; Osler; rare disease; epistaxis
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	51461

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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: ...

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).

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Metadata last modified: 26 Mar 2024 10:45

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