Cardiovascular DiseaseHAPPYLondonNCT01911910
Heart Attack Prevention Programme for You (HAPPY) London
A study of Cardiovascular Disease, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Diseases of the heart and blood vessels, such as heart attacks and strokes, are very common and can lead to severe disability or death. Changes in the body leading to heart attacks and strokes usually develop over decades as a result of smoking, diet, and lack of exercise, obesity, diabetes and high blood pressure. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Cardiovascular Disease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2013to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be enrolled following an informed consent. The subject will be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- Subjects will be between 40 and 74 years of age
- Subjects will have unrestricted access to the Internet
- Subjects will be sufficiently fluent in English language.
- Subjects will have an estimated intermediate to high risk for CV events based on the web-based pre-screening tool (www.happylondon.info), which is based on the nonlaboratory Framingham risk score (>10% 10 year cardiovascular risk)
Who cannot join
- History of stroke or transient ischaemic attack (TIA)
- Cardiac sounding chest pain requiring further investigations
- Current life threatening conditions other than vascular disease (e.g. very severe chronic airways disease, HIV positive, life-threatening arrhythmias) that may prevent a subject from completing the study
- Only for subgroup undergoing cardiac contrast-enhanced magnetic resonance studies: Any contraindication to a contrast-enhanced magnetic resonance study, such as known allergies to gadolinium-based contrast agents, severe claustrophobia, pacemakers, defibrillators, etc
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Advanced Cardiovascular Imaging, William Harvey Research Institute, Queen May University of London
London, E2 9JX
About this study
Diseases of the heart and blood vessels, such as heart attacks and strokes, are very common and can lead to severe disability or death. Changes in the body leading to heart attacks and strokes usually develop over decades as a result of smoking, diet, and lack of exercise, obesity, diabetes and high blood pressure. Changes in lifestyle and diet can significantly reduce the risk of heart diseases. General Practitioners invite 40 to 74 year-olds who have no known heart disease to take part in the NHS Health Check, which measures each person's individual risk of developing a heart attack or stroke and encourages them in a face-to-face meeting to take part in programmes to help them to give up smoking, lose weight etc. where necessary. In this new clinical trial the investigators will test whether computer-tailored electronic (e)-coaching via email and the internet can help people make the necessary changes in their lifestyle to reduce the risk of heart attacks and strokes.
Read the detailed description
Heart Attack Prevention Programme for You London (HAPPY London) will be conducted as a randomised controlled trial comparing the use of tailored e-coaching in addition to the standard of care vs. standard care alone. Standard care is defined as the care that would be offered by the NHS Health Check programme through the NHS primary care. We will use a range of established and novel cardiovascular markers to determine the clinical and cost effectiveness of e-coaching and gain pathophysiological insight into how lifestyle modifications affect the cardiovascular system. These measures include cardiovascular magnetic resonance imaging (CMR), aortic stiffness parameters, vascular ultrasound and other biomarkers of CV disease risk.
Intervention
The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based on the modified Framingham score and the UK specific QRisk Score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen 'buddies' from family or friends to view their progress will aim to further encourage healthier behaviour.
The study involves the recruitment of 400 adults between the age of 40 and 74 years who have a moderate to high 10-year CV risk score (Estimated 10 year CV risk >10%). Half of the study group will receive use of the e-coaching in addition to standard care allocated randomly stratified according to either moderate (QRisk between 10 and 20%) or high risk (QRisk more than or equal to 20%). The initial screening will take place on the www.happylondon.info web-based 'mini-check' questionnaire. Potential participants will then be seen at a physical screening visit to confirm eligibility. 3 subsequent visits will take place over 6 months; baseline, 3 month and 6 month follow up. A subgroup of the study population (65 from each intervention arm thus totalling 130 participants ) will also have a baseline and follow up cardiovascular magnetic resonance (CMR) imaging. Assessment will be performed using a variety of measures through questionnaires, blood pressure (BP) checks, blood tests, ultrasound scans, oscillometric method to assess pulse wave velocity and pulse wave analysis and CMR multi-parametric scanning.
The primary aim of this study is to assess the clinical effectiveness of individualised, continuous electronic (e-) coaching to support a healthier lifestyle as a primary prevention tool to reduce the CV risk and improve the quality of life in asymptomatic individuals with intermediate to high 10 year CV risk.
Other questions that we aim to answer are:
- Is computer-tailored e-coaching cost-effective in the short-term (clinical trial period) and during the long-term (decision analysis modelling)
- What are the associations of personality traits, economic preferences, and sociocultural factors with the achieved lifestyle modifications and changes in the cardiovascular phenotype?
- What is the relationship between changes observed in markers derived from our multi-parametric cardiovascular magnetic resonance imaging protocols following lifestyle changes?
- How frequent are silent myocardial infarctions in a typical NHS Health Check population?
- Do treatment effects differ between ethnic groups?
- Conditions
- Cardiovascular Disease
- Being tested
- Electronic coaching plus standard care
- Keywords
- primary prevention, Cardiovascular disease, Cardiovascular magnetic resonance (CMR), Electronic coaching (e-coaching)
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic coaching plus standard careBehavioural
Also called Electronic coaching, E-Coaching, HAPPY E-Coaching
The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Usual care that would be provided by the NHS Health Check or equivalent. |
| Electronic coaching plus standard care | Experimental | Tailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. Receives: Behavioral: Electronic coaching plus standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulse Wave Velocity (PWV)
Change in aortic stiffness using a Vicorder device measured in m/s
Measured: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Secondary outcomes (17)
Change in Carotid Intima Media Thickness CIMT
carotid intima media thickness CIMT as measured by ultrasound
Measured: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in Quality of Life
Lifestyle, quality of life and physical activity questionnaires. Questionnaires SF-36, EQ5D-3L, RPAQ.
Measured: Assessed at Baseline visit, 3 months and 6 months; Data not reported as full analysis not done due to time constraints
Pulse Wave Velocity by CMR
Change in aortic stiffness as measured by CMR derived aortic pulse wave velocity measured in m/s
Measured: Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.
Aortic Distensibility by Cardiovascular Magnetic Resonance (CMR)
CMR will be performed on 65 participants in the treatment and 65 in the standard care group.
Change in aortic stiffness - aortic distensibility (mmHg-1, CMR)).
Measured: Baseline and 6 month
Left Ventricular Mass by CMR
Change in LV mass index (g/m2, CMR).
Measured: Baseline and 6 month
Left Ventricular Ejection Fraction by CMR
LV end-diastolic and end-systolic volume indices, (ml/m2, CMR), LV EF (%, CMR).
Measured: Baseline and 6 month
Myocardial Fibrosis by CMR
Extent and change in diffuse myocardial fibrosis (extracellular volume fraction measured as a %, derived from CMR imaging)
Measured: Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.
Diastolic Function by CMR
Diastolic function (strain and strain rate in % and s-1, respectively derived from CMR imaging data).
This is a measure of how stiff the main chamber of the heart is. The software to analyse these data will be available in the future.
The raw images from the scan will be used for future analysis once software for this assessment is developed. Our group is working on developing this tool.
Measured: Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.
Change in Framingham Risk Score
Assessment of cardiovascular risk based on the Framingham algorithm. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.
Assessment of 10-year cardiovascular risk score based on the Framingham population derived algorithm.
Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.
Measured: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in QRisk Score
Assessment of cardiovascular risk score based on the QRisk risk score. Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.
Assessment of cardiovascular risk score based on the UK standardised using the QRISK2 algorithm (www.qrisk.org).
Minimum value 0% and maximum value theoretically 100%. Higher score means worse predicted outcome.
Measured: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in Total Cholesterol to HDL Ratio
Ratio of Total cholesterol to HDL from blood test for lipid profile. Change in the ratio of total cholesterol to HDL cholesterol ratio as assessed though cholesterol blood test. Negative value suggests an improvement.
Measured: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in LDL Cholesterol
Bloods for lipid profile. Change in the level of LDL cholesterol as assessed though cholesterol blood test. Negative value for change suggests an improvement.
Measured: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in Glucose Levels
Fasting glucose bloods. This is an assessment for presence of diabetes and control of blood sugar levels on the day of the test.
Change in the blood glucose level as measure on the day of the visit as a measure of blood sugar level. Negative value would suggest an improvement.
Measured: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in hsCRP
baseline and change in hsCRP blood test. hsCRP is measured through a blood test and is a marker of inflammation. Change in the hsCRP level though a blood test. Negative value suggests an improvement.
Measured: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in Physical Activity
Lifestyle, quality of life and physical activity questionnaires. Questionnaires SF-36, EQ5D-3L, RPAQ
Measured: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in Systolic Blood Pressure
Change in systolic blood pressure measured during sitting position
Measured: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in Diastolic Blood Pressure
Change in diastolic blood pressure measure during sitting position.
Measured: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust
- Responsible party
- Principal investigator, Dr Steffen Erhard Petersen, Queen Mary University of London
- Investigators
- Steffen E Petersen, MD DPhil, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911910
- Sponsor's protocol ID
- ReDa: 007711
- Acronym
- HAPPYLondon
- Status last verified
- Sep 2020
- First submitted
- 22 Jul 2013
- Last updated
- 12 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Khanji MY, Balawon A, Boubertakh R, Hofstra L, Narula J, Hunink M, Pugliese F, Petersen SE. Personalized E-Coaching in Cardiovascular Risk Reduction: A Randomized Controlled Trial. Ann Glob Health. 2019 Jul 12;85(1):107. doi: 10.5334/aogh.2496.
PubMed 31298823Khanji MY, Stone IS, Boubertakh R, Cooper JA, Barnes NC, Petersen SE. Chronic Obstructive Pulmonary Disease as a Predictor of Cardiovascular Risk: A Case-Control Study. COPD. 2020 Feb;17(1):81-89. doi: 10.1080/15412555.2019.1694501. Epub 2019 Dec 13.
PubMed 31833441
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Attack Prevention Programme for You (HAPPY) London
- ClinicalTrials.gov ID
- NCT01911910
- Acronym / sponsor ID
- HAPPYLondon / ReDa: 007711
- Conditions
- Cardiovascular Disease
- Keywords
- primary prevention, Cardiovascular disease, Cardiovascular magnetic resonance (CMR), Electronic coaching (e-coaching)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust
- Study start
- Jun 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Posted 12 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diseases of the heart and blood vessels, such as heart attacks and strokes, are very common and can lead to severe disability or death. Changes in the body leading to heart attacks and strokes usually develop over decades as a result of smoking, diet, and lack of exercise, obesity, diabetes and high blood pressure. Changes in lifestyle and diet can significantly reduce the risk of heart diseases. General Practitioners invite 40 to 74 year-olds who have no known heart disease to take part in the NHS Health Check, which measures each person's individual risk of developing a heart attack or stroke and encourages them in a face-to-face meeting to take part in programmes to help them to give up smoking, lose weight etc. where necessary. In this new clinical trial the investigators will test whether computer-tailored electronic (e)-coaching via email and the internet can help people make the necessary changes in their lifestyle to reduce the risk of heart attacks and strokes.
Detailed description
Heart Attack Prevention Programme for You London (HAPPY London) will be conducted as a randomised controlled trial comparing the use of tailored e-coaching in addition to the standard of care vs. standard care alone. Standard care is defined as the care that would be offered by the NHS Health Check programme through the NHS primary care. We will use a range of established and novel cardiovascular markers to determine the clinical and cost effectiveness of e-coaching and gain pathophysiological insight into how lifestyle modifications affect the cardiovascular system. These measures include cardiovascular magnetic resonance imaging (CMR), aortic stiffness parameters, vascular ultrasound and other biomarkers of CV disease risk.
Intervention
The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based on the modified Framingham score and the UK specific QRisk Score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen 'buddies' from family or friends to view their progress will aim to further encourage healthier behaviour.
The study involves the recruitment of 400 adults between the age of 40 and 74 years who have a moderate to high 10-year CV risk score (Estimated 10 year CV risk >10%). Half of the study group will receive use of the e-coaching in addition to standard care allocated randomly stratified according to either moderate (QRisk between 10 and 20%) or high risk (QRisk more than or equal to 20%). The initial screening will take place on the www.happylondon.info web-based 'mini-check' questionnaire. Potential participants will then be seen at a physical screening visit to confirm eligibility. 3 subsequent visits will take place over 6 months; baseline, 3 month and 6 month follow up. A subgroup of the study population (65 from each intervention arm thus totalling 130 participants ) will also have a baseline and follow up cardiovascular magnetic resonance (CMR) imaging. Assessment will be performed using a variety of measures through questionnaires, blood pressure (BP) checks, blood tests, ultrasound scans, oscillometric method to assess pulse wave velocity and pulse wave analysis and CMR multi-parametric scanning.
The primary aim of this study is to assess the clinical effectiveness of individualised, continuous electronic (e-) coaching to support a healthier lifestyle as a primary prevention tool to reduce the CV risk and improve the quality of life in asymptomatic individuals with intermediate to high 10 year CV risk.
Other questions that we aim to answer are:
- Is computer-tailored e-coaching cost-effective in the short-term (clinical trial period) and during the long-term (decision analysis modelling)
- What are the associations of personality traits, economic preferences, and sociocultural factors with the achieved lifestyle modifications and changes in the cardiovascular phenotype?
- What is the relationship between changes observed in markers derived from our multi-parametric cardiovascular magnetic resonance imaging protocols following lifestyle changes?
- How frequent are silent myocardial infarctions in a typical NHS Health Check population?
- Do treatment effects differ between ethnic groups?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Usual care that would be provided by the NHS Health Check or equivalent. |
| Electronic coaching plus standard care | Experimental | Behavioral: Electronic coaching plus standard careTailored coaching for participants randomised to use the HAPPY e-coaching tool. Access to lifestyle and heart health scores and personalised advice to improve suboptimal behaviour. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects will be enrolled following an informed consent. The subject will be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
- Subjects will be between 40 and 74 years of age
- Subjects will have unrestricted access to the Internet
- Subjects will be sufficiently fluent in English language.
- Subjects will have an estimated intermediate to high risk for CV events based on the web-based pre-screening tool (www.happylondon.info), which is based on the nonlaboratory Framingham risk score (>10% 10 year cardiovascular risk)
Key exclusion criteria (4 listed)
- History of stroke or transient ischaemic attack (TIA)
- Cardiac sounding chest pain requiring further investigations
- Current life threatening conditions other than vascular disease (e.g. very severe chronic airways disease, HIV positive, life-threatening arrhythmias) that may prevent a subject from completing the study
- Only for subgroup undergoing cardiac contrast-enhanced magnetic resonance studies: Any contraindication to a contrast-enhanced magnetic resonance study, such as known allergies to gadolinium-based contrast agents, severe claustrophobia, pacemakers, defibrillators, etc
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 |
|---|---|---|
| Electronic coaching plus standard careAlso: Electronic coaching, E-Coaching, HAPPY E-CoachingThe HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour. | Behavioural | Electronic coaching plus standard care |
Primary outcome
Change in Pulse Wave Velocity (PWV)
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in aortic stiffness using a Vicorder device measured in m/s
17 secondary outcomes
Change in Carotid Intima Media Thickness CIMT
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in Quality of Life
Time frame: Assessed at Baseline visit, 3 months and 6 months; Data not reported as full analysis not done due to time constraints
Pulse Wave Velocity by CMR
Time frame: Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.
Aortic Distensibility by Cardiovascular Magnetic Resonance (CMR)
Time frame: Baseline and 6 month
Left Ventricular Mass by CMR
Time frame: Baseline and 6 month
Left Ventricular Ejection Fraction by CMR
Time frame: Baseline and 6 month
Myocardial Fibrosis by CMR
Time frame: Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.
Diastolic Function by CMR
Time frame: Baseline and 6 month. Baseline and 6 month. Data not reported as full analysis not possible due to time and resource limitations.
Change in Framingham Risk Score
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in QRisk Score
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in Total Cholesterol to HDL Ratio
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in LDL Cholesterol
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in Glucose Levels
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in hsCRP
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in Physical Activity
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in Systolic Blood Pressure
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Change in Diastolic Blood Pressure
Time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31298823Khanji MY, Balawon A, Boubertakh R, Hofstra L, Narula J, Hunink M, Pugliese F, Petersen SE. Personalized E-Coaching in Cardiovascular Risk Reduction: A Randomized Controlled Trial. Ann Glob Health. 2019 Jul 12;85(1):107. doi: 10.5334/aogh.2496.
- Derived from this study: PubMed 31833441Khanji MY, Stone IS, Boubertakh R, Cooper JA, Barnes NC, Petersen SE. Chronic Obstructive Pulmonary Disease as a Predictor of Cardiovascular Risk: A Case-Control Study. COPD. 2020 Feb;17(1):81-89. doi: 10.1080/15412555.2019.1694501. Epub 2019 Dec 13.
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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.
Steffen E Petersen, MD DPhil principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cardiovascular Disease, run by Queen Mary University of 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 5 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: finished, as of the sponsor's last update on 12 Oct 2020. 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?
Yes. Results are posted in the registry (first posted 12 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pulse Wave Velocity (PWV) (time frame: Assessed at Baseline visit, 3 months and 6 months; Month 6 reported). 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 NCT01911910, 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 12 Oct 2020.