NCT04157205Active, not recruiting
Prospective Evaluation Of Exercise-Induced Cardiac Conduction Instability In Predicting Ventricular Fibrillation Events In Hypertrophic Cardiomyopathy
Source: ClinicalTrials.gov · Last updated 2 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (actual)
- First submitted
- 6 Nov 2019
- Start date
- 10 Nov 2019
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Imperial College London
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT04157205
What you commit to
- Study type: Interventional
- Participants enrolled: 200
- From 10 Nov 2019 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous cardiac arrest
- Patients with previous appropriate therapy from an ICD.
Other illness
- Evidence of one of the following conditions causing secondary hypertrophy:
- 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 skin allergies to ECG gel/electrodes.
Age
- Patients under the age of 18 years
Other
- Patients with haemodynamically unstable VT needing medical attention.
- Patients who are not safe to discontinue Beta blockers
- Patients unable to exercise due to musculoskeletal problems
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.