N/A
N=402
Heart Attack Prevention Programme for You (HAPPY) London
Cardiovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01911910 ↗Enrolled (actual)
402
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Change in Pulse Wave Velocity (PWV) — -0.25; -0.16 m/s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electronic coaching plus standard care (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Queen Mary University of London
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pulse Wave Velocity (PWV) |
-0.25; -0.16 | — |
| SECONDARY Change in Carotid Intima Media Thickness CIMT |
0.01; 0.01 | — |
| SECONDARY Change in Quality of Life |
0.01; 0 | — |
| SECONDARY Pulse Wave Velocity by CMR |
— | — |
| SECONDARY Aortic Distensibility by Cardiovascular Magnetic Resonance (CMR) |
— | — |
| SECONDARY Left Ventricular Mass by CMR |
-1.42; -1.73 | — |
| SECONDARY Left Ventricular Ejection Fraction by CMR |
-0.45; -0.88 | — |
| SECONDARY Myocardial Fibrosis by CMR |
— | — |
| SECONDARY Diastolic Function by CMR |
— | — |
| SECONDARY Change in Framingham Risk Score |
-1.37; -1.23 | — |
| SECONDARY Change in QRisk Score |
-0.05; 0.2 | — |
| SECONDARY Change in Total Cholesterol to HDL Ratio |
-0.11; -0.04 | — |
| SECONDARY Change in LDL Cholesterol |
-0.2; -0.16 | — |
| SECONDARY Change in Glucose Levels |
-0.27; -0.29 | — |
| SECONDARY Change in hsCRP |
0; -0.26 | — |
| SECONDARY Change in Physical Activity |
8.45; 25.1 | — |
| SECONDARY Change in Systolic Blood Pressure |
-1.69; -3.18 | — |
| SECONDARY Change in Diastolic Blood Pressure |
-2.08; -2.37 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01911910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.