Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-25 @ 4:56 AM
NCT ID:
NCT04139018
Eligibility Criteria:
Inclusion Criteria:
1. Adults ages 20 and older
2. Confirmed clinical (meeting at least 3 of the 4 Curaçao Criteria) or genetic diagnosis of HHT
3. Epistaxis Severity Score (ESS) ≥ 4 and 2 or more nosebleeds per week with a cumulative nosebleed duration of at least 5 minutes per week
4. Stable nasal hygiene and medical regimen for preceding 1 month
5. Stable epistaxis pattern over the preceding 3 months
Exclusion Criteria:
1. Contraindications for systemic β adrenergic blocker administration
1. Hypersensitivity to β adrenergic blockers
2. Asthma or bronchospasm
3. Congestive heart failure with LVEF \<40%
4. Hereditary pulmonary arterial hypertension
5. Baseline bradycardia (HR \<55 beats per minute)
6. Sick Sinus Syndrome
7. 2nd or 3rd degree heart block, left or right bundle branch block, or bifasicular block
8. Uncontrolled diabetes mellitus (most recent HbA1c \>9%) or diabetic ketoacidosis within last 6 months
9. Hypotension (systolic blood pressure \< 90)
2. Known hypersensitivity to timolol
3. Severe peripheral circulatory disturbances (Raynaud phenomenon)
4. Known intermediate or poor metabolizer variant of the liver enzyme CYP2D6
5. Current use of any of the following known strong CYP2D6 inhibitors: fluoxetine (Prozac), paroxetine (Paxil), bupropion (Welbutrin), quinidine, quinine, ritonavir (Norvir), and terbinafine (Lamisil)
6. Current use of the following other drugs known to pharmacodynamically interact with timolol: diltiazem, verapamil, digoxin, digitalis, propafenone, disopyramide, clonidine, flecainide, or lidocaine
7. Patients currently treated or who plan to initiate treatment with β-blockers
8. Use of any anti-angiogenic medication in the last month prior to recruitment, including bevacizumab, pazopanib, thalidomide, or lenalidomide
9. Illicit drug use, except marijuana
10. Known pheochromocytoma
11. Use of anticoagulants, antiplatelet, or fibrinolytic therapies within the last month prior to recruitment, except for low-dose (81 mg or less) of aspirin
12. Pregnancy or planned pregnancy in the next 6 months or currently breastfeeding
13. Inability to read or understand English
14. Inability to complete 8 weeks of therapy for any reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04139018
Study Brief:
Protocol Section:
NCT04139018