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NCT04552275 · ClinicalTrials.gov registry record · Phase 1
The HALT Biomarker Study
A Phase 1 study of Aortic Stenosis and Hypo-attenuated Leaflet Thickening, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 300
- Enrollment target
- 3
- Study locations
NCT04552275 is a Phase 1 study of Aortic Stenosis and Hypo-attenuated Leaflet Thickening that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 300 participants, below the 1,351-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT04552275, a Phase 1 study of Aortic Stenosis and Hypo-attenuated Leaflet Thickening, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 300 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis of HALT; to characterize changes in circulating proteins after treatment of HALT with systemic anticoagulation; and to identify circulating proteins that predict the occurrence of HALT. The study population will be adult patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) or bioprosthetic valve degeneration. Enrollment will continue until 30 patients with HALT are identified for completion of phase 1. Based on a HALT incidence rate of 10%, we anticipate enrolling 300 patients. Patients are enrolled prior to undergoing transfemoral TAVR. Blood samples, clinical data and echocardiograms will be collected at the following timepoints: baseline (pre-TAVR, T0), post-TAVR (pre-discharge, T1), 30-day follow-up (window 3-9 weeks, T2), and 6-month follow-up (T3). Cardiac 4D CT will be performed at the 30-day follow-up visit to screen for the occurrence of HALT. Patients with HALT will be treated with systemic anticoagulation for 5-6 months, at which point a follow-up CT scan and blood sample will be obtained. Control subjects will also undergo a 6-month study visit with blood sample collection. The study will be conducted within two phases. Phase 1 will serve as a derivation / discovery study in which candidate protein biomarkers of HALT will be identified. Once this is successfully completed, a second cohort will be enrolled within phase 2. Phase 2 will be performed under the auspices a future contract or amendment and will seek to cross-validate the initial study findings.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Proteomics Analysis
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
Minnesota
- Minneapolis Heart Institute - Minneapolis
New Hampshire
- Catholic Medical Center - Manchester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2020-06-22 |
| Est. Completion | 2035-06-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04552275
The ClinicalTrials.gov registry entry for NCT04552275 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,351-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (78% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Aortic Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Proteomics Analysis is the first listed.
NCT04552275 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Massachusetts, Minnesota, New Hampshire.
Frequently Asked Questions
What is clinical trial NCT04552275 about?
NCT04552275 is a clinical study titled "The HALT Biomarker Study". The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis of HALT; to characterize changes in circulating proteins after treatment...
What is the current status of trial NCT04552275?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2020-06-22. Estimated completion is 2035-06-22.
What conditions does trial NCT04552275 study?
This clinical trial studies the following conditions: Aortic Stenosis, Hypo-attenuated Leaflet Thickening, Bioprosthetic Valve Degeneration.
What interventions are being tested in trial NCT04552275?
The interventions under investigation include: Proteomics Analysis (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04552275?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04552275 being conducted?
This trial has 3 study locations across Massachusetts, Minnesota, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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