LANDI-POAF study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]

Trial duration

18 Oct 2021 → ongoing

Decision date (initial)

2025-01-27

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Department of Anesthesia, Intensive Care Medicine and Pain Medicine, Medical University Vienna · AOP Orphan Pharmaceuticals GmbH

External identifiers

EU CT number

2024-518950-17-00

EudraCT number

2020-002752-20

ClinicalTrials.gov

NCT20245189

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

Prevention of postoperative atrial fibrillation using landiolol hydrochloride in patients undergoing elective on-pump cardiac surgery

Secondary objectives 1

1. Incidence/ frequency of occurrence of atrial fibrillation during the first seven days after cardiac surgery.

Conditions and MedDRA coding

Beta-blocker intake

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male or female patients ≥ 18 years old
2. Written informed consent from patient
3. Patients are in sinus rhythm
4. Oral Betablocker in the patients long-term medication
5. One of the following cardiac surgical procedures which is planned on cardiopulmonary bypass (CPB): a. Single valve surgery b. Single or multiple CABG procedures c. Single valve surgery in combination with one or multiple coronary artery bypass grafts (CABGs) d. Multiple valve surgery in combination with or without CABG e. Single or multiple valve surgery in combination with ascending aorta procedure with or without additional CABG f. Re-surgery of aortic valve, mitral valve, aortic arch or ascending aorta with or without CABG
6. Cardiac surgery is performed electively

Exclusion criteria 21

1. Bodyweight > 101kg and/or BMI ≥ 40
2. Cardiac surgery is planned as minimally invasive procedure (e.g., without thoracotomy or with lateral incision, minimal thoracotomy) or planned as off-pump surgery
3. Planned maze procedure, radiofrequency ablation, pulmonary vein ablation, resection of the atrial appendix or atrial resections during the surgery
4. Sinus bradycardia (resting heart rate < 50/min) at screening and before start of IMP treatment
5. Second- or third-degree atrioventricular block at screening and before start of IMP treatment
6. Clinical hypothyroidism or hyperthyroidism at screening
7. History of ventricular arrhythmia
8. Permanent atrial fibrillation or atrial fibrillation at time of screening and IMP administration
9. Emergency cardiac surgery
10. Requiring inotropic, vasopressor or requiring ventilatory support at time of screening
11. Circulatory shock requiring mechanical circulatory support before initiation of study medication
12. Distributive shock (cardiac index>2.2 L/min with norepinephrine dose > 0.3 µg/kg/min to reach mean arterial pressure > 65mmHg) before initiation of study medication
13. More than 5 units of RBC necessary to maintain a haemoglobin level >8mg/dl at the end of surgery
14. Prior cardiac surgery within the past 6 months
15. History of heart transplantation or planned heart transplantation
16. Any other disease or condition that is likely to interfere with the evaluation of the study drug, outcome assessment or satisfactory conduct of the study: a. Active infective endocarditis b. Stroke or transient ischemic attack (TIA) within the last 6 months c. Concomitant disease with a life expectancy of less than 6 months d. Cardiopulmonary resuscitation within the last 4 weeks e. Patients requiring renal replacement therapy
17. Active infection on current systemic antibiotics and/ or temperature greater than 38°C at time of screening and before start of surgery
18. Haemoglobin < 5 mmol/l (< 8.06 g/dl)
19. Any systemic anti-cancer therapy within past 3 months
20. Patients with known hypersensitivity to any constituent of the IMP
21. General exclusion criteria: a. Pregnant (in women of childbearing potential a urine or blood pregnancy test has to be performed) or breast-feeding women. Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial b. Participation in any interventional clinical trial within the last one-month prior randomization in this clinicaltrial (screening failures can be rescreened, if appropriate) c. Alcohol, drug, or medication abuse d. Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, subinvestigators, or study nurse) or relationship to the sponsor

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary end point is a combined endpoint consisting of the occurrence of atrial fibrillation and mortality during the initial 72 hours period after surgery.

Secondary endpoints 1

1. Occurrence of atrial fibrillation during the initial seven days after surgery • Initiation of standard of care for atrial fibrillation because of postoperative atrial fibrillation • Hemodynamic stability assessed by systolic blood pressure, diastolic blood pressure, and heart rate (in patients on pacing, the pacemaker will be stopped before measurement of blood pressure and heart rate) at time of admission to the intensive care unit (ICU), at 24, 48 and 72 hours and 7 days after administr

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Division of Cardiothoracic and Vascular Anesthesia and Intensive Care Medicine

Public contact point

Organisation

Medical University Of Vienna

Contact name

Division of Cardiothoracic and Vascular Anesthesia and Intensive Care Medicine

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications