NCT04552275: HALT

The HALT Biomarker Study

Recruiting now Phase 1 Last updated 10 November 2021

What this trial tests

Phase 1 trial testing Proteomics Analysis in Aortic Stenosis in 300 participants. Currently enrolling.

Timeline

22 June 2020

Primary endpoint
22 June 2030

22 June 2035

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	300
Start date	22 June 2020
Primary completion	22 June 2030
Estimated completion	22 June 2035
Sites	3 locations across United States

Drugs / interventions tested

• Proteomics Analysis

Conditions studied

• Aortic Stenosis — all drugs for Aortic Stenosis →
• Hypo-attenuated Leaflet Thickening — all drugs for Hypo-attenuated Leaflet Thickening →
• Bioprosthetic Valve Degeneration — all drugs for Bioprosthetic Valve Degeneration →

Sponsor

Massachusetts General Hospital

Who can join

65 and older, any sex, with Aortic Stenosis or Hypo-attenuated Leaflet Thickening. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.