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 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT05679193
Eligibility Criteria:
Inclusion Criteria:
* European Association of Urology Intermediate- and High Risk for Biochemical recurrence and planned for curative RALP
* ECOG Performance Status 0-1
Exclusion Criteria:
Medical Conditions
1. Sick sinus syndrome
2. Atrioventricular (AV) block grade 2 and 3
3. Recent (3 months) myocardial infarction
4. Known unstable- or vasospastic- angina
5. Heart failure (New York Heart Association \[NYHA\] \> 2)
6. Symptomatic peripheral vascular disease (e.g. intermittent claudication)
7. Known pulmonary hypertension
8. Known carotid artery stenosis or recent (3 months) stroke
9. Bronchial asthma or other chronic obstructive pulmonary disease (COPD)
10. Kidney failure (estimated Glomerular filtration rate \[eGFR\]\<50)
11. Liver failure (cirrhosis, jaundice, signs of hepatic decompression)
12. Unregulated diabetes mellitus
13. Untreated thyroid disorder
14. Depressive episode within last 6 months (within last 12 months if major depressive episode)
15. Known drug allergy against propranolol or excipients
16. Any medical conditions considered to prohibit Propranolol use as judged by the treating physician (including frailty).
17. Participants with known substance- or alcohol-abuse
Prior/Concomitant Therapy
18. Recent (\<3 month) use of systemic beta-blockers prior to screening.
19. Patients receiving non-dihydropyridine calcium channel blocking agents (eg diltiazem, verapamil)
20. Patients receiving anti-arrhythmic agents (e.g. amiodarone, sotalol, digoxin, verapamil, flecainide)
21. Patients receiving digoxin, rizatriptan, hydralazine, fluvoksamin, or fluoksetin
22. Patients using daily anxiolytics (e.g. benzodiazepines), alpha-receptor adrenergic agonists (e.g. clonidine)
23. Recommendations in the Summary of Product Characteristics for propranolol regarding concomitant use of other medications will be adhered to.
Diagnostic assessments
24. Sinus bradycardia (\<60 beats/minute)
25. Resting blood pressure \<110/60mmHg OR hypertension BP \>160/100
26. AV-block 2 or 3 on ECG
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT05679193
Study Brief:
Protocol Section:
NCT05679193