Prospective Evaluation Of Exercise-Induced Cardiac Conduction Instability In Predicting Ventricular Fibrillation Events In Hypertrophic Cardiomyopathy

NCT04157205 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 17SM4246
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertrophic Cardiomyopathy (HCM) is an inherited heart condition. Most people who have it are unaware of any problems relating to it. Unfortunately, a small number of people with the condition can suddenly develop a dangerous fast heart beat that can lead to death. There is no cure, but implanting a cardioverter-defibrillator (ICD), which is like a pacemaker can save the life of affected individuals. However, ICD implantation has its own problems, so choosing who gets an ICD is a very important decision. The current approach for recommending people for an ICD has limitations and a better method is needed. Investigators have developed a new technique called the 'Ventricular Conduction Stability' (V-CoS). This involves wearing a special vest which records electrical signals from the heart, and then running on a treadmill. Investigators have used it to identify abnormalities in the hearts of people with HCM who have also survived a life-threatening event. This project aims to test new tool against current methods to ascertain which is better at identifying patients who should have an ICD.

Conditions

Hypertrophic Cardiomyopathy

Keywords

sudden cardiac arrest; defibrillator

Outcome Measures

Primary Outcomes (1)

• Number of Participants with sudden cardiac death, or appropriate therapy from ICD for VT/VF.

  Sudden cardiac death, or appropriate therapy from ICD for VT/VF follow up assessed by phone call to study participant

  5 years

Secondary Outcomes (5)

• Number of Participants with syncopal events of unknown cause in patients without ICDs

  5 years

• Number of Participants with inappropriate therapy from ICD

  5 years

• Number of Participants with indeterminate therapy from ICD

  5 years

• Number of Participants with complications from ICD implant

  5 years

• Number of Participants with complications from performing V-CoS test

  5 years

Study Arms (1)

Test arm

EXPERIMENTAL

All patients. Single arm study

Diagnostic Test: Non-invasive ECG imaging - CardioInsight test

Interventions

Non-invasive ECG imaging - CardioInsight test DIAGNOSTIC_TEST

1. Consent session 2. Fitting of ECGi vest and CT scan of the chest 3. Supervised exercise test and Valsalva maneuvre 4. Programmed stimulation via ICD (selected participants) 5. Blood tests - genetics

Test arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Does the patient have maximum wall thickness \>13mm by any imaging technique? i) If so, does the patient have a first degree relative (sibling, parent, child) with a formal diagnosis of HCM -AND- ii) Does the patient have any of the following: Does the patient have any of the following: abnormal Doppler myocardial imaging or strain, incomplete systolic anterior motion, elongation of mitral valve leaflets and abnormal papillary muscles, abnormal ECG? -OR-
• Does the patient have maximum wall thickness 15mm or more by any imaging technique?
• Is the patient male or female 18-100years of age?
• High or intermediate risk for sudden cardiac death from HCM based on the ESC risk calculator predicting \>4% risk over 5 years by specialist inherited cardiac disease clinic. This would use the online SCD-risk calculator

You may not qualify if:

• Patients with previous cardiac arrest
• Patients with haemodynamically unstable VT needing medical attention.
• Evidence of one of the following conditions causing secondary hypertrophy:
• a. Hypertension \>200/100; Severe aortic stenosis; Anderson-Fabry disease; Myocarditis; Congenital heart disease; TTR-related amyloidosis; Myotonic dystrophy; Mitochondrial disease, Noonan syndrome, LEOPARD syndrome, Costello syndrome, Danon disease, Friedreich's ataxia, Glycogen storage disease, FHLI mutation, PRKAG2 mutations
• Patients with previous appropriate therapy from an ICD.
• Patients under the age of 18 years
• Patients who are not safe to discontinue Beta blockers
• Patients unable to exercise due to musculoskeletal problems
• Patients with skin allergies to ECG gel/electrodes.
• Life expectancy shorter than the duration of the trial.
• Pregnant or planning pregnancy at the time of CT scan.
• Patients unable to consent to the study protocol or provide contact details for follow up.
• Patients currently participating in an interventional medical or device trial.

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator
• Medtronic: collaborator
• Barts & The London NHS Trust: collaborator
• Daniel Bagshaw Trust: collaborator
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Brighton and Sussex University Hospitals NHS Trust: collaborator
• University Hospital of Wales: collaborator
• Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK): collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Prapa Kanagaratnam, FRCP, PhD

  Imperial College NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: November 10, 2019
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)