MedTrace Logo

Mechanisms of Excess Risk in Aortic Stenosis

NCT04627987 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 192

Last updated 2021-04-30

No results posted yet for this study

Summary

Aortic stenosis (AS) is caused by narrowing of one of the main heart valves. Replacing the valve is the only treatment to prevent the heart from failing or death. The timing of replacement is currently often too late - half of patients are left with permanent scarring and a quarter die within 3.5 years.

Studies are underway to see if earlier replacement makes a difference. But for those with scarring of the heart, there is currently no tailored treatment. I want to change this by understanding why and how patients with scar are dying and what the investigators can do to prevent this.

In this study, the investigators will use a heart scan (MRI) to detect scarring before valve replacement. After replacement, patients will receive a tiny monitor (paper clip size), which the investigators inject underneath the skin. This monitor continuously checks the heartbeat and can detect increased body fluid due to heart failure. The investigators will monitor patients for an average of 3 years to see if scarring is linked to abnormal heart rhythms and heart failure.

Once the investigators know how and why, the investigators can target patients with available medications and design studies using specialised treatments, eg defibrillator implantation, to protect patients with scar from dying.

Conditions

Interventions

DIAGNOSTIC_TEST

Cardiac MRI scan

Cardiac MRI scan pre- and post- aortic valve replacement to assess degree of left ventricular remodelling, fibrosis and myocardial blood flow.

DIAGNOSTIC_TEST

Serum biomarkers (High sensitivity troponin, NT-proBNP

Blood tests looking evidence of cardiac structural remodelling and function.

PROCEDURE

Implantable Loop Recorder

Determine post-AVR arrhythmia burden

DIAGNOSTIC_TEST

6 minute walk test

Validated assessment of functional capacity - distance walked over 6 minute time frame.

DIAGNOSTIC_TEST

Echocardiogram

Ultrasound assessment of heart structure and function. Standard of care in valve surgery pathway.

Sponsors & Collaborators

  • Barts & The London NHS Trust

    collaborator OTHER

  • University College, London

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04627987 on ClinicalTrials.gov