Inherited Cardiac ConditionsULTIMATE-ANCT07014579
Using Heart Electrical Signals to Study How Well Treatments Prevent Dangerous Heart Rhythms in Active People
An observational study of Inherited Cardiac Conditions and Sudden Cardiac Arrest, run by University of Leicester at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to learn if two specific heart electrical signal patterns can help in detecting the risk of dangerous heart rhythms in athletes, and to see if exercise-based tests can be used instead of invasive hospital procedures to record this electrical signals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inherited Cardiac Conditions, Sudden Cardiac Arrest, Ventricular Arrhythmia
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2025to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will be from a single tertiary care hospital (University Hospitals Leicester), and residents of United Kingdom
Who may be able to join
- Age 18 and over.
- Participates in regular physical activity for at least 3 hours or greater weekly.
- Having Implantable cardioverter defibrillator insitu (cases).
- Having a cardiac pacemaker (control).
- Having no cardiac device (control).
- Sufficient capacity and agreement to participate orally and signed written consent forms.
- Understanding of written and spoken English language.
Who cannot join
- Pregnancy, as detected by positive urine pregnancy test result.
- Inability to comply with study protocols.
- Any iatrogenic cardiac pathology (stents, CABG etc).
- Unstable ventricular tachycardia (>30 seconds).
- Any unstable malignant arrhythmia.
- Fever or presence of a clinically diagnosed febrile illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Glenfield Hospital
Leicester, Leicestershire, LE3 9QP
About this study
Official title: Utilizing LifeMap To Investigate Malignant Arrhythmia Therapeutic Efficacy in Athletes
The goal of this observational study is to learn if two specific heart electrical signal patterns can help in detecting the risk of dangerous heart rhythms in athletes, and to see if exercise-based tests can be used instead of invasive hospital procedures to record this electrical signals.
The main questions it aims to answer are:
Read more
- Can special ECG action potential duration markers (R2I2 and PERS) identify athletes who are at higher risk of sudden heart rhythm problems.
- Can an exercise test give the same information as a non-invasive electrophysiology study.
Researchers will compare athletes who have an implanted heart device (ICD) with athletes who do not, to see if there are differences in these heart signals.
Participants will undergo:
- ECG recordings during rest and exercise.
- If they have an ICD or pacemaker, an ECG will be recorded during a non invasive stimulation.
- A continuous 24 hour ECG.
- Conditions
- Inherited Cardiac Conditions, Sudden Cardiac Arrest, Ventricular Arrhythmia, Athlete, Ventricular Fibrillation
- Keywords
- ULTIMATE-Athlete, LifeMap, R2I2, PERS, Ventricular Arrhythmia, Ventricular Fibrillation, Sudden Cardiac Death
- Medical subject headings
- Death, Sudden, Cardiac, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with ICD | Those that exercise 3 hours or more per week and/or have a physically active occupation (e.g military, fire service, landscaper, etc.) and have been identified as at risk of sudden cardiac death. Therefore have been implanted with an implantable defibrillator (ICD) for primary or secondary prevention. | |
| Participants without heart device | Those that exercise 3 hours or more per week and/or have a physically active occupation (e.g military, fire service, landscaper, etc.) and do not have any heart condition. Therefore have not been implanted with any heart device. | |
| Participants with Pacemaker | Those that exercise 3 hours or more per week and/or have a physically active occupation (e.g military, fire service, landscaper, etc.) and have not been identified as at risk of sudden cardiac death. Therefore do not have an implantable cardioverter defibrillator, but have been implanted with a cardiac pacemaker due to other conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Restitution Markers as Determined by R2I2 and PERS
Measured: The primary outcome measure is assessment of changes in the regional restitution instability index and peak ECG restitution slope at various time points including, baseline, during 15-minute exercise and during 15-minute electrophysiology study.
Secondary outcomes (1)
Non-invasive exercise-based tests correlate with electrophysiology study.
Measured: The secondary outcome looks at how the Regional Restitution Instability Index (R2I2) and Peak ECG restitution slope (PERS) measurements during a 15-minute exercise compare with those taken during 15 minute Non-Invasive Programmed Stimulation (NIPS).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inherited Cardiac ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ghulam André Ng, MBChB, MRCP, Ph.D, FRCP, Study director, University of Leicester, Leicestershire, United KingdomGhulam André Ng, MBChB, MRCP, Ph.D, FRCP, FHEA, Principal investigator, University of Leicester, Leicestershire, United KingdomXin Li, PhD, MSc, BSc, FHEA, Principal investigator, University of Leicester, Leicestershire, United KingdomHarshil Dhutia, MBBS, BSC, MRCP, CCDS, MD(RES), Principal investigator, Glenfield Hospital, Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014579
- Sponsor's protocol ID
- 1037
- Other IDs
- NIHR203327
- Acronym
- ULTIMATE-A
- Status last verified
- Jun 2025
- First submitted
- 28 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided yet due to study committee and study sponsor needing to deliberate
Publications
Nicolson WB, Smith MI, Vali Z, Samani NJ, Ng GA. Application of two novel electrical restitution-based ECG markers of ventricular arrhythmia to patients with nonischemic cardiomyopathy. Pacing Clin Electrophysiol. 2021 Feb;44(2):284-292. doi: 10.1111/pace.14143. Epub 2021 Jan 4.
PubMed 33336815Ng GA, Mistry A, Li X, Schlindwein FS, Nicolson WB. LifeMap: towards the development of a new technology in sudden cardiac death risk stratification for clinical use. Europace. 2018 Sep 1;20(FI2):f162-f170. doi: 10.1093/europace/euy080.
PubMed 29684162
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing LifeMap To Investigate Malignant Arrhythmia Therapeutic Efficacy in Athletes
- ClinicalTrials.gov ID
- NCT07014579
- Acronym / sponsor ID
- ULTIMATE-A / 1037
- Conditions
- Inherited Cardiac Conditions, Sudden Cardiac Arrest, Ventricular Arrhythmia, Athlete, Ventricular Fibrillation
- Keywords
- ULTIMATE-Athlete, LifeMap, R2I2, PERS, Ventricular Arrhythmia, Ventricular Fibrillation, Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn if two specific heart electrical signal patterns can help in detecting the risk of dangerous heart rhythms in athletes, and to see if exercise-based tests can be used instead of invasive hospital procedures to record this electrical signals.
The main questions it aims to answer are:
- Can special ECG action potential duration markers (R2I2 and PERS) identify athletes who are at higher risk of sudden heart rhythm problems.
- Can an exercise test give the same information as a non-invasive electrophysiology study.
Researchers will compare athletes who have an implanted heart device (ICD) with athletes who do not, to see if there are differences in these heart signals.
Participants will undergo:
- ECG recordings during rest and exercise.
- If they have an ICD or pacemaker, an ECG will be recorded during a non invasive stimulation.
- A continuous 24 hour ECG.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants with ICD | – | –Those that exercise 3 hours or more per week and/or have a physically active occupation (e.g military, fire service, landscaper, etc.) and have been identified as at risk of sudden cardiac death. Therefore have been implanted with an implantable defibrillator (ICD) for primary or secondary prevention. |
| Participants without heart device | – | –Those that exercise 3 hours or more per week and/or have a physically active occupation (e.g military, fire service, landscaper, etc.) and do not have any heart condition. Therefore have not been implanted with any heart device. |
| Participants with Pacemaker | – | –Those that exercise 3 hours or more per week and/or have a physically active occupation (e.g military, fire service, landscaper, etc.) and have not been identified as at risk of sudden cardiac death. Therefore do not have an implantable cardioverter defibrillator, but have been implanted with a cardiac pacemaker due to other conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be from a single tertiary care hospital (University Hospitals Leicester), and residents of United Kingdom
Key inclusion criteria (7 listed)
- Age 18 and over.
- Participates in regular physical activity for at least 3 hours or greater weekly.
- Having Implantable cardioverter defibrillator insitu (cases).
- Having a cardiac pacemaker (control).
- Having no cardiac device (control).
Key exclusion criteria (6 listed)
- Pregnancy, as detected by positive urine pregnancy test result.
- Inability to comply with study protocols.
- Any iatrogenic cardiac pathology (stents, CABG etc).
- Unstable ventricular tachycardia (>30 seconds).
- Any unstable malignant arrhythmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Restitution Markers as Determined by R2I2 and PERS
Time frame: The primary outcome measure is assessment of changes in the regional restitution instability index and peak ECG restitution slope at various time points including, baseline, during 15-minute exercise and during 15-minute electrophysiology study.
1 secondary outcome
Non-invasive exercise-based tests correlate with electrophysiology study.
Time frame: The secondary outcome looks at how the Regional Restitution Instability Index (R2I2) and Peak ECG restitution slope (PERS) measurements during a 15-minute exercise compare with those taken during 15 minute Non-Invasive Programmed Stimulation (NIPS).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Background: PubMed 33336815Nicolson WB, Smith MI, Vali Z, Samani NJ, Ng GA. Application of two novel electrical restitution-based ECG markers of ventricular arrhythmia to patients with nonischemic cardiomyopathy. Pacing Clin Electrophysiol. 2021 Feb;44(2):284-292. doi: 10.1111/pace.14143. Epub 2021 Jan 4.
- Background: PubMed 29684162Ng GA, Mistry A, Li X, Schlindwein FS, Nicolson WB. LifeMap: towards the development of a new technology in sudden cardiac death risk stratification for clinical use. Europace. 2018 Sep 1;20(FI2):f162-f170. doi: 10.1093/europace/euy080.
- LifeMap is a novel, highly promising technique for assessing risk of sudden cardiac death, a condition that kills 3 million people annuallyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Undecided yet due to study committee and study sponsor needing to deliberate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ghulam André Ng, MBChB, MRCP, Ph.D, FRCP study director
University of Leicester, Leicestershire, United Kingdom
Ghulam André Ng, MBChB, MRCP, Ph.D, FRCP, FHEA principal investigator
University of Leicester, Leicestershire, United Kingdom
Xin Li, PhD, MSc, BSc, FHEA principal investigator
University of Leicester, Leicestershire, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inherited Cardiac Conditions and Sudden Cardiac Arrest, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdulmalik I Koya, MD (+4407990290755, aik8@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Restitution Markers as Determined by R2I2 and PERS (time frame: The primary outcome measure is assessment of changes in the regional restitution instability index and peak ECG restitution slope at various time points including, baseline, during 15-minute exercise and during 15-minute electrophysiology study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07014579, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.