The HALT Biomarker Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04552275
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Stenosis
  • Bioprosthetic Valve Degeneration
  • Hypo-attenuated Leaflet Thickening

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Proteomics Analysis — DIAGNOSTIC_TEST
    Determine a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT)

Study Details

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.

Key Dates

Start date
Jun 22, 2020
Status verified
Nov 2021
Primary completion
Jun 22, 2030
Completion
Jun 22, 2035

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Other: HALT Cohort
    Patients who develop HALT
  • Other: Control Group
    Patients who do not develop HALT

Primary Outcome Measure

Derivation of the panel of circulating proteins indicative of HALT [ Time Frame: 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Sammy Elmariah, MD (PRINCIPAL_INVESTIGATOR)
Minneapolis Heart InstituteMinneapolisMinnesota55407
Santiago Garcia, MD (PRINCIPAL_INVESTIGATOR)
Catholic Medical CenterManchesterNew Hampshire03103
Fahad S Gilani (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital· Boston, MAMinneapolis Heart Institute· Minneapolis, MNCatholic Medical Center· Manchester, NH

Related Studies