Identifying biomarkers for Hypo-Attenuated Leaflet Thickening in heart patients
Circulating Biomarkers of Hypo-Attenuated Leaflet Thickening After Transcatheter Aortic Valve Replacement
PHASE1 · Massachusetts General Hospital · NCT04552275
This study is trying to find specific proteins in the blood that can help tell if older heart patients have a condition called Hypo-Attenuated Leaflet Thickening and see how these proteins change after treatment.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT04552275 on ClinicalTrials.gov |
What this trial studies
The HALT Biomarker Study aims to identify a panel of circulating proteins that can distinguish between patients with and without Hypo-Attenuated Leaflet Thickening (HALT). It will also assess changes in these proteins after treatment with systemic anticoagulation and identify proteins that may predict HALT occurrence. The study will enroll adult patients over 65 years old who are undergoing transfemoral transcatheter aortic valve replacement (TAVR) for severe aortic stenosis or bioprosthetic valve degeneration. Blood samples and clinical data will be collected at various time points to achieve these objectives.
Who should consider this trial
Good fit: Ideal candidates are adults over 65 years with severe aortic stenosis or bioprosthetic valve degeneration undergoing TAVR.
Not a fit: Patients with chronic anticoagulation therapy or significant comorbidities that limit life expectancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic accuracy for HALT and improve patient management strategies.
How similar studies have performed: Other studies have explored biomarker identification in similar contexts, suggesting potential for success, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \> 65 years 2. Subject with severe native AS or severe bioprosthetic valve degeneration 3. Subject undergoing transfemoral TAVR using a Medtronic Evolut R, Evolut Pro or Evolut Pro+ transcatheter heart valve Exclusion Criteria: 1. Chronic anticoagulation therapy 2. Contraindication to systemic oral anticoagulation therapy 3. Chronic kidney disease with EGFR\<30 ml/min 4. Bleeding diathesis or known coagulopathy 5. Hypercoagulable state 6. Life-expectancy \<12 months due to other medical conditions (e.g., malignancy, severe Alzheimer's disease, etc.) 7. The patient is currently participating in another investigational device or drug study that has not reached its primary objective/endpoint 8. Pregnant, lactating, or planning pregnancy within next 12 months
Where this trial is running
Boston, Massachusetts and 2 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Minneapolis Heart Institute — Minneapolis, Minnesota, United States (NOT_YET_RECRUITING)
- Catholic Medical Center — Manchester, New Hampshire, United States (RECRUITING)
Study contacts
- Study coordinator: Roukoz Abou Karam
- Email: raboukaram@mgh.harvard.edu
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.
Conditions: Aortic Stenosis, Hypo-attenuated Leaflet Thickening, Bioprosthetic Valve Degeneration