Using conestat alfa to prevent brain and kidney problems after heart valve surgery
Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Acute Ischemic Cerebral and Renal Events After Transcatheter Aortic Valve Implantation: a Multi-center, Randomized, Double-blind, Placebo-controlled Investigational Study (PAIR-TAVI).
This study is testing whether a medication called conestat alfa can help prevent brain and kidney problems in people undergoing heart valve surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 2 sites (Basel and 1 other locations) |
| Trial ID | NCT05145283 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety and effectiveness of conestat alfa (Ruconest®) in preventing acute ischemic strokes and renal injuries in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis. The study compares the outcomes of patients receiving conestat alfa to those receiving a placebo. Given the risks of embolic events associated with TAVI, this research aims to address a significant gap in preventive care for these complications. The trial will include patients who meet specific eligibility criteria and will monitor their health outcomes post-procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with severe aortic stenosis scheduled for transfemoral TAVI.
Not a fit: Patients with contraindications to conestat alfa or those with severe co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of acute ischemic strokes and renal injuries in patients undergoing TAVI.
How similar studies have performed: While the use of conestat alfa in this context is novel, previous studies have shown its potential in reducing ischemic damage in other settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent as documented by signature * Severe AS and scheduled for transfemoral TAVI Exclusion Criteria: * Contraindications to the class of drugs under study (C1INH), e.g., known hypersensitivity or allergy to class of drugs or the investigational product * History of allergy to rabbits (as rhC1INH is derived from the breast milk of transgenic rabbits) * Women who are pregnant or breast feeding * Hemodynamic instability requiring emergency TAVI * Valve-in-valve procedure * Other access route than transfemoral * Non-cardiac co-morbidity with expected survival \<6 months * Ischemic or hemorrhagic stroke within 30 days before TAVI * Dialysis or estimated glomerular filtration rate (eGFR) \<20 ml/min/1.73m2 * Contraindication for MRI such as a permanent non-MRI compatible pacemaker or severe claustrophobia * Liver cirrhosis (any Child-Pugh score) * Incapacity or inability to provide informed consent * Participation in another study with investigational drug or medical device within the 30 days preceding and during the present study * Previous enrolment into the current study * Any uncontrolled or significant concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements at the discretion of the investigator
Where this trial is running
Basel and 1 other locations
- University Hospital Basel, Division of Internal Medicine — Basel, Switzerland (Recruiting)
- Stadtspital Triemli Zürich, Division of Cardiology — Zürich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Michael Osthoff, Prof. Dr. med. — University Hospital Basel, Division of Internal Medicine
- Study coordinator: Michael Osthoff, Prof. Dr. med.
- Email: michael.osthoff@usb.ch
- Phone: +41 61 328 54 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.