FrailtyMyoFit46NCT05455125
MultiMorbidity Life-Course Approach To Myocardial Health -A Cardiac Sub-Study of the MRC National Survey of Health and Development (NSHD)
An observational study of Frailty and Cardiovascular Diseases, run by University College, London at 1 site in United Kingdom.
Trial summary
Background The life course accumulation of overt and subclinical myocardial dysfunction contributes to older age mortality, frailty, disability and loss of independence. The Medical Research Council National Survey of Health and Development (NSHD) is the world's longest running continued surveillance birth cohort… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Frailty, Cardiovascular Diseases
- What is being tested?
- CMR CGI
- How many people
- 550 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2020to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: NSHD cohort
Who may be able to join
- NSHD study member.
- Who is still alive and agreed to take part in the study.
Who cannot join
- Pacemaker.
- Implantable cardio defibrillator.
- Atrial fibrillation.
- Complete heart block.
- Severe asthma.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
UCL Bloomsbury Centre for Clinical Phenotyping
London, SW13 0JD
Gabriella Captur, 07809621264, gabriella.captur@ucl.ac.uk
About this study
Official title: A Cardiac Sub-Study of the MRC National Survey of Health and Development (NSHD)
Background The life course accumulation of overt and subclinical myocardial dysfunction contributes to older age mortality, frailty, disability and loss of independence. The Medical Research Council National Survey of Health and Development (NSHD) is the world's longest running continued surveillance birth cohort providing a unique opportunity to understand life course determinants of myocardial dysfunction as part of MyoFit46-the cardiac sub-study of the NSHD.
Methods and expected results The investigators aim to recruit 550 NSHD participants of approximately 75 years+ to undertake high-density surface electrocardiographic imaging (ECGI) and stress perfusion cardiovascular magnetic resonance (CMR). Through comprehensive myocardial tissue characterization and 4-dimensional flow the investigators hope to better understand the burden of clinical and subclinical cardiovascular disease. Supercomputers will be used to combine the multi-scale ECGI and CMR datasets per participant. Rarely available, prospectively collected whole-of-life data on exposures, traditional risk factors and multimorbidity will be studied to identify risk trajectories, critical change periods, mediators and cumulative impacts on the myocardium.
Conclusion By combining well curated, prospectively acquired longitudinal data of the NSHD with novel CMR-ECGI data and sharing these results and associated pipelines with the CMR community, MyoFit46 seeks to transform our understanding of how early, mid and later-life risk factor trajectories interact to determine the state of cardiovascular health in older age.
- Conditions
- Frailty, Cardiovascular Diseases
- Being tested
- CMR CGI
- Medical subject headings
- Frailty, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMR CGIDiagnostic test
High resolution ECGI plus advanced CMR
What is being measured
The primary outcome is the main question the study is designed to answer.
CMR phenotype - T1
This will be assessed through a 45 minute cardiac MRI scan with perfusion.
Measured: Through study completion, an average of 4 years.
CMR phenotype - T2
This will be assessed through a 45 minute cardiac MRI scan with perfusion.
Measured: Through study completion, an average of 4 years.
CMR phenotype - Myocardial blood flow
This will be assessed through a 45 minute cardiac MRI scan with perfusion.
Measured: Through study completion, an average of 4 years.
CMR phenotype - Aortic blood flow
This will be assessed through a 45 minute cardiac MRI scan with perfusion.
Measured: Through study completion, an average of 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Jul 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455125
- Sponsor's protocol ID
- 123172
- Acronym
- MyoFit46
- Status last verified
- Jul 2022
- First submitted
- 16 Feb 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Non-identifiable data sharing to external collaborators. Additional data sharing available within UCL TRE.
Publications
Webber M, Chan F, Topriceanu CC, Martin E, Joy G, Bennett J, Falconer D, Morselli F, Shiwani H, Gonzalez P, Hamill Howes L, Wong A, Rapala A, Bandula S, Davies RH, Kellman P, Pierce I, Orini M, Hardy R, Chaturvedi N, Moon JC, Lambiase PD, Hughes AD, Captur G. Incidental findings and duty-of-care protocols in cardiovascular magnetic resonance among older adults: a prospective population-based study from MyoFit46. Lancet Healthy Longev. 2026 Feb;7(2):100823. doi: 10.1016/j.lanhl.2026.100823. Epub 2026 Mar 5.
PubMed 41796595Topriceanu CC, Webber M, Shiwani H, Chan F, Martin E, Falconer D, Stanley MA, Bennett J, Gonzalez-Martin P, Shah H, De S, Wong A, Pierce I, Davies RH, Lambiase PD, Chaturvedi N, Kellman P, Hardy R, Moon JC, Hughes AD, Captur G. Higher Life-Course Blood Pressure Associates With Reduced Myocardial Perfusion in Older Age: Insights From MyoFit46. Circ Cardiovasc Imaging. 2026 Feb;19(2):e019105. doi: 10.1161/CIRCIMAGING.125.019105. Epub 2025 Nov 8.
PubMed 41404671Webber M, Joy G, Bennett J, Chan F, Falconer D, Shiwani H, Davies RH, Krausz G, Tanackovic S, Guger C, Gonzalez P, Martin E, Wong A, Rapala A, Direk K, Kellman P, Pierce I, Rudy Y, Vijayakumar R, Chaturvedi N, Hughes AD, Moon JC, Lambiase PD, Tao X, Koncar V, Orini M, Captur G. Technical development and feasibility of a reusable vest to integrate cardiovascular magnetic resonance with electrocardiographic imaging. J Cardiovasc Magn Reson. 2023 Dec 4;25(1):73. doi: 10.1186/s12968-023-00980-7.
PubMed 38044439
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cardiac Sub-Study of the MRC National Survey of Health and Development (NSHD)
- ClinicalTrials.gov ID
- NCT05455125
- Acronym / sponsor ID
- MyoFit46 / 123172
- Conditions
- Frailty, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Jul 2022 (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.
Background The life course accumulation of overt and subclinical myocardial dysfunction contributes to older age mortality, frailty, disability and loss of independence. The Medical Research Council National Survey of Health and Development (NSHD) is the world's longest running continued surveillance birth cohort providing a unique opportunity to understand life course determinants of myocardial dysfunction as part of MyoFit46-the cardiac sub-study of the NSHD.
Methods and expected results The investigators aim to recruit 550 NSHD participants of approximately 75 years+ to undertake high-density surface electrocardiographic imaging (ECGI) and stress perfusion cardiovascular magnetic resonance (CMR). Through comprehensive myocardial tissue characterization and 4-dimensional flow the investigators hope to better understand the burden of clinical and subclinical cardiovascular disease. Supercomputers will be used to combine the multi-scale ECGI and CMR datasets per participant. Rarely available, prospectively collected whole-of-life data on exposures, traditional risk factors and multimorbidity will be studied to identify risk trajectories, critical change periods, mediators and cumulative impacts on the myocardium.
Conclusion By combining well curated, prospectively acquired longitudinal data of the NSHD with novel CMR-ECGI data and sharing these results and associated pipelines with the CMR community, MyoFit46 seeks to transform our understanding of how early, mid and later-life risk factor trajectories interact to determine the state of cardiovascular health in older age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- NSHD cohort
Key inclusion criteria (2 listed)
- NSHD study member.
- Who is still alive and agreed to take part in the study.
Key exclusion criteria (5 listed)
- Pacemaker.
- Implantable cardio defibrillator.
- Atrial fibrillation.
- Complete heart block.
- Severe asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMR CGIHigh resolution ECGI plus advanced CMR | Diagnostic test | – |
Primary outcome
CMR phenotype - T1
Time frame: Through study completion, an average of 4 years.
This will be assessed through a 45 minute cardiac MRI scan with perfusion.
CMR phenotype - T2
Time frame: Through study completion, an average of 4 years.
This will be assessed through a 45 minute cardiac MRI scan with perfusion.
CMR phenotype - Myocardial blood flow
Time frame: Through study completion, an average of 4 years.
This will be assessed through a 45 minute cardiac MRI scan with perfusion.
CMR phenotype - Aortic blood flow
Time frame: Through study completion, an average of 4 years.
This will be assessed through a 45 minute cardiac MRI scan with perfusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Derived from this study: PubMed 41796595Webber M, Chan F, Topriceanu CC, Martin E, Joy G, Bennett J, Falconer D, Morselli F, Shiwani H, Gonzalez P, Hamill Howes L, Wong A, Rapala A, Bandula S, Davies RH, Kellman P, Pierce I, Orini M, Hardy R, Chaturvedi N, Moon JC, Lambiase PD, Hughes AD, Captur G. Incidental findings and duty-of-care protocols in cardiovascular magnetic resonance among older adults: a prospective population-based study from MyoFit46. Lancet Healthy Longev. 2026 Feb;7(2):100823. doi: 10.1016/j.lanhl.2026.100823. Epub 2026 Mar 5.
- Derived from this study: PubMed 41404671Topriceanu CC, Webber M, Shiwani H, Chan F, Martin E, Falconer D, Stanley MA, Bennett J, Gonzalez-Martin P, Shah H, De S, Wong A, Pierce I, Davies RH, Lambiase PD, Chaturvedi N, Kellman P, Hardy R, Moon JC, Hughes AD, Captur G. Higher Life-Course Blood Pressure Associates With Reduced Myocardial Perfusion in Older Age: Insights From MyoFit46. Circ Cardiovasc Imaging. 2026 Feb;19(2):e019105. doi: 10.1161/CIRCIMAGING.125.019105. Epub 2025 Nov 8.
- Derived from this study: PubMed 38044439Webber M, Joy G, Bennett J, Chan F, Falconer D, Shiwani H, Davies RH, Krausz G, Tanackovic S, Guger C, Gonzalez P, Martin E, Wong A, Rapala A, Direk K, Kellman P, Pierce I, Rudy Y, Vijayakumar R, Chaturvedi N, Hughes AD, Moon JC, Lambiase PD, Tao X, Koncar V, Orini M, Captur G. Technical development and feasibility of a reusable vest to integrate cardiovascular magnetic resonance with electrocardiographic imaging. J Cardiovasc Magn Reson. 2023 Dec 4;25(1):73. doi: 10.1186/s12968-023-00980-7.
- Individual participant dataSharing planned: No. Non-identifiable data sharing to external collaborators. Additional data sharing available within UCL TRE.
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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. This study is not recruiting at the moment.
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 Frailty and Cardiovascular Diseases, run by University College, London 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriella Captur, MD PhD MSc MRCP (+447809621264, gabycaptur@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMR phenotype - T1 (time frame: Through study completion, an average of 4 years.). The study lists 4 primary outcomes in all. 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 NCT05455125, which also lists 3 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 13 Jul 2022.