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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: Recruiting Phase 1 study of Aortic Stenosis and Hypo-attenuated Leaflet Thickening, sponsored by Massachusetts General Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
1\. Establish the incidence of similar proteomic profiles and the rate to which the profile occurs in TAVR recipients with HALT via a high-throughput precision proteomics platform which utilizes the proximity extension assay (PEA). PEA merges a dual-recognition antibody-based immunoassay with quantitative real-time PCR that allows for the simultaneous quantification of 92 proteins. We will focus on the 5 highest yield panels for the current investigation: cardiovascular II, cardiovascular III, c
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 |
What NCT04552275 shows while recruiting
NCT04552275 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,351-participant average among 26 other Aortic Stenosis trials with a reported enrollment target (78% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04552275's enrollment target sits among peer trials
300 11th of 26 higher than 16 of 26 other Aortic Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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