Atrial FibrillationEMPOWERNCT03987633
EMPOWER-1: A Multi-site Clinical Cohort Research Study to Reduce Health Inequality
An observational study of Atrial Fibrillation and Coronary Heart Disease, run by Future Genetics Limited at 1 site in United Kingdom.
Trial summary
Health inequality and genetic disparity are a significant issue in the United Kingdom (UK). This study focuses on diseases that are associated with significant morbidity and mortality in the UK, and specifically examines the extent and basis of treatment failure in different patient populations. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Coronary Heart Disease, Cardiovascular Diseases
- How many people
- 200,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2020to 1 Feb 2030
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals who are registered as UK NHS patients.
Who may be able to join
- Patients or their relative/family member is diagnosed with the illness being investigated by this study.
- All NHS patients that are associated with a participating study site, but do not fall under the first bullet point above, may participate with a view that they may potentially contribute to a case control population in the research study.
- Subjects agree to:
- Gift biological samples, i.e. saliva. Where practical, blood or other biological samples may be voluntarily provided by the patient.
- Provide Consent for access to medical records.
- Complete disease specific, quality of life, and study associated questionnaires.
Who cannot join
- Patient does not provide a valid consent for study participation.
- Patient is not registered with the NHS for care.
- Patient lacking capacity, who does not have an illness that is being specifically investigated by this clinical research study.
- Person lacks capacity and where the personal consultee has not advised that the Person may enrol, in accordance with the Mental Health Act 2005.
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, 1 recruiting
- Recruiting
Future Genetics, The Science Centre, Wolverhampton Science Park
Wolverhampton, West Midlands, WV10 9RU
Mohammed Kamran, PhD, 00441216673007, director@futuregenetics.co.uk
About this study
Official title: EMPOWER-1: A Multi-site Clinical Cohort Study to Reduce Health Inequality: Identifying Ethnic Disparities in Treatment Failures for Medicines Prescribed to Treat Diseases That Cause Significant Mortality and Morbidity in the UK Population
Health inequality and genetic disparity are a significant issue in the United Kingdom (UK).
This study focuses on diseases that are associated with significant morbidity and mortality in the UK, and specifically examines the extent and basis of treatment failure in different patient populations.
Read more
The vast majority of drug registration clinical trials have under-representation of ethnic minority populations. In addition, the wider Caucasian populations have reasonably different clinical characteristics to the population that participated in the drug licencing clinical trials. A consequence of this is that drugs are licensed for use in real-world general patient populations where the clinical trial results are simply not statistically significant to specifically demonstrate efficacy or safety in populations that were either absent or under-represented in the drug registration clinical trials. When these facts are considered alongside data that supports significant under-reporting of adverse events in the real-world setting within the UK (and globally, e.g the USA and Europe), it highlights that pharmacovigilance systems are unable to capture drug effectiveness and safety data in a manner that can reasonably assure appropriate prescribing in the wider patient populations.
This large real-world research study aims to identify whether commonly prescribed drugs are effective in treating illnesses that cause significant poor health and death in the different patient populations that represent the UK.
The goal of this study is to generate large quantitative data-sets that may inform clinical practice to reduce the existing health inequality and genetic disparity in the UK.
Read the detailed description
This multi-centre real-world study will recruit patients across different National Health Service (NHS) sites based in England, where the overall patient population demographic profile is sufficiently variable to allow for meaningful representation of different ethnicities in the analysis of pooled data-sets.
The study addresses the issue of health inequality and genetic disparity in the United Kingdom (UK) by recruiting up to 200,000 patients primarily from the three main ethnic groups in the UK; namely White (Caucasian), African-Caribbean (Black), and South Asian (Asian) populations on a 1:1:1 ratio.
Biological samples, medical records, alongside specific questionnaires will be used in data analyses to help identify treatment failures in different populations for the 19 disease areas under investigation, which are a significant cause of morbidity and mortality in the UK.
Analysis of patient populations may provide real-world evidence around disease prevalence between and within different ethnic groups. The data may also support hypothesis driven genetic analysis to identify putative bio-markers associated with treatment failure.
Data from this study will be published, and findings could better inform clinical practice in the management of diseases that cause significant poor health and death in the different populations that represent the UK.
- Conditions
- Atrial Fibrillation, Coronary Heart Disease, Cardiovascular Diseases, Heart Failure, Hypertension, Peripheral Arterial Disease
- Keywords
- genetic disparity, health inequality, genetics, health outcomes, equality
- Medical subject headings
- Atrial Fibrillation, Coronary Disease, Cardiovascular Diseases, Heart Failure, Hypertension, Peripheral Arterial Disease, Ischemic Stroke, Asthma
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 |
|---|---|---|
| Displaying trait of interest | There are 19 disease areas under investigation. Enrolled patients are segmented into cohorts based on data collected through questionnaires and medical histories. This data-driven approach does not allow for precisely predefined cohorts for the diseases under investigation. Therefore, as a default, the two general predefined cohorts are set as either displaying or not displaying a trait that would form the basis of an investigation. | |
| Not displaying trait of interest | Please see above. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ethnic disparities in treatment failure
Identify ethnic disparities in treatment failures for any of the 19 disease states under investigation. The primary outcome is treatment failure, as measured by the discontinuation of a treatment regimen by a clinician in the absence of the cure of the disease, for the most common treatment in each of the 19 diseases.
Measured: Ongoing review of data, anticipated completion of primary outcome analysis 4 years post launch
Secondary outcomes (2)
Ethnic disparities in disease incidence
Identifying ethnic disparities in disease incidence. The corresponding secondary outcome measure for this is, for each of the 19 diseases under consideration, the diagnosis of the disease. We will use time to diagnosis to examine ethnic disparities in incidence.
Measured: Ongoing review of data, anticipated completion of analysis 5 years post launch
Identification of candidate genetic variants associated with observed disparities in treatment failure.
Another secondary outcome is identifying candidate genetic variants that may underpin observed disparities in treatment failure, for treatments in the 19 diseases under consideration. The corresponding secondary outcome measures used for this are genotypes as identified through whole genome sequencing (WGS) of patient saliva or peripheral blood that are associated with the phenotypes corresponding to the treatment failure previously described as the primary outcome measure.
Measured: Ongoing review of data, anticipated completion of analysis 5 years post launch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2019
- Study start1 Feb 2020
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future Genetics Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Mohammed Kamran, Study director, Future Genetics Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03987633
- Sponsor's protocol ID
- EMPOWER-1
- Acronym
- EMPOWER
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2019
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPOWER-1: A Multi-site Clinical Cohort Study to Reduce Health Inequality: Identifying Ethnic Disparities in Treatment Failures for Medicines Prescribed to Treat Diseases That Cause Significant Mortality and Morbidity in the UK Population
- ClinicalTrials.gov ID
- NCT03987633
- Acronym / sponsor ID
- EMPOWER / EMPOWER-1
- Conditions
- Atrial Fibrillation, Coronary Heart Disease, Cardiovascular Diseases, Heart Failure, Hypertension, Peripheral Arterial Disease
- Keywords
- genetic disparity, health inequality, genetics, health outcomes, equality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Future Genetics LimitedUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 17 Jun 2019 (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.
Health inequality and genetic disparity are a significant issue in the United Kingdom (UK).
This study focuses on diseases that are associated with significant morbidity and mortality in the UK, and specifically examines the extent and basis of treatment failure in different patient populations.
The vast majority of drug registration clinical trials have under-representation of ethnic minority populations. In addition, the wider Caucasian populations have reasonably different clinical characteristics to the population that participated in the drug licencing clinical trials. A consequence of this is that drugs are licensed for use in real-world general patient populations where the clinical trial results are simply not statistically significant to specifically demonstrate efficacy or safety in populations that were either absent or under-represented in the drug registration clinical trials. When these facts are considered alongside data that supports significant under-reporting of adverse events in the real-world setting within the UK (and globally, e.g the USA and Europe), it highlights that pharmacovigilance systems are unable to capture drug effectiveness and safety data in a manner that can reasonably assure appropriate prescribing in the wider patient populations.
This large real-world research study aims to identify whether commonly prescribed drugs are effective in treating illnesses that cause significant poor health and death in the different patient populations that represent the UK.
The goal of this study is to generate large quantitative data-sets that may inform clinical practice to reduce the existing health inequality and genetic disparity in the UK.
Detailed description
This multi-centre real-world study will recruit patients across different National Health Service (NHS) sites based in England, where the overall patient population demographic profile is sufficiently variable to allow for meaningful representation of different ethnicities in the analysis of pooled data-sets.
The study addresses the issue of health inequality and genetic disparity in the United Kingdom (UK) by recruiting up to 200,000 patients primarily from the three main ethnic groups in the UK; namely White (Caucasian), African-Caribbean (Black), and South Asian (Asian) populations on a 1:1:1 ratio.
Biological samples, medical records, alongside specific questionnaires will be used in data analyses to help identify treatment failures in different populations for the 19 disease areas under investigation, which are a significant cause of morbidity and mortality in the UK.
Analysis of patient populations may provide real-world evidence around disease prevalence between and within different ethnic groups. The data may also support hypothesis driven genetic analysis to identify putative bio-markers associated with treatment failure.
Data from this study will be published, and findings could better inform clinical practice in the management of diseases that cause significant poor health and death in the different populations that represent the UK.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Displaying trait of interest | – | –There are 19 disease areas under investigation. Enrolled patients are segmented into cohorts based on data collected through questionnaires and medical histories. This data-driven approach does not allow for precisely predefined cohorts for the diseases under investigation. Therefore, as a default, the two general predefined cohorts are set as either displaying or not displaying a trait that would form the basis of an investigation. |
| Not displaying trait of interest | – | –Please see above. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals who are registered as UK NHS patients.
Key inclusion criteria (6 listed)
- Patients or their relative/family member is diagnosed with the illness being investigated by this study.
- All NHS patients that are associated with a participating study site, but do not fall under the first bullet point above, may participate with a view that they may potentially contribute to a case control population in the research study.
- Subjects agree to:
Key exclusion criteria (4 listed)
- Patient does not provide a valid consent for study participation.
- Patient is not registered with the NHS for care.
- Patient lacking capacity, who does not have an illness that is being specifically investigated by this clinical research study.
- Person lacks capacity and where the personal consultee has not advised that the Person may enrol, in accordance with the Mental Health Act 2005.
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
Ethnic disparities in treatment failure
Time frame: Ongoing review of data, anticipated completion of primary outcome analysis 4 years post launch
Identify ethnic disparities in treatment failures for any of the 19 disease states under investigation. The primary outcome is treatment failure, as measured by the discontinuation of a treatment regimen by a clinician in the absence of the cure of the disease, for the most common treatment in each of the 19 diseases.
2 secondary outcomes
Ethnic disparities in disease incidence
Time frame: Ongoing review of data, anticipated completion of analysis 5 years post launch
Identification of candidate genetic variants associated with observed disparities in treatment failure.
Time frame: Ongoing review of data, anticipated completion of analysis 5 years post launch
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 10 Mar 2025.
- FUTURE GENETICS websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Dr Mohammed Kamran study director
Future Genetics Limited
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 Atrial Fibrillation and Coronary Heart Disease, run by Future Genetics Limited 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Mar 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 Dr Mohammed Kamran (00441216673007, director@futuregenetics.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ethnic disparities in treatment failure (time frame: Ongoing review of data, anticipated completion of primary outcome analysis 4 years post launch). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2025.