Cardiovascular DiseasesHUDDLENCT05009589
HUDDLE: Heart Health: Understanding & Diagnosing Disease by Leveraging Echocardiograms
An observational study of Cardiovascular Diseases and Heart Diseases, run by Edwards Lifesciences at 1 site in United States.
Trial summary
This study will screen for the presence of cardiovascular disease and provide education about the signs and symptoms of cardiovascular disease and heart disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases
- How many people
- 552 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2021to 7 Oct 2022
- 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 50 years and older
- All sexes
- Adult, Older adult
Study population: This study will include participants identified at pre-planned screening events for cardiovascular disease who provide informed consent.
Key Eligibility Criteria:
- at least 50 years of age on the day of the screening event
- informed of the nature of the study, agrees to its provisions, and has provided written informed consent
- does not have any conditions that would interfere with obtaining an echocardiogram of the heart
Trial locations and contacts
1 site in 1 country.
About this study
This study will screen for the presence of cardiovascular disease and provide education about the signs and symptoms of cardiovascular disease and heart disease.
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal structural heart findings
The number of patients with abnormal structural heart findings as identified by echocardiography
Measured: 30 days
Abnormal electrocardiography findings
The number of patients with abnormal electrocardiography findings such as rhythm disturbances, bundle branch or fascicular block, or other conduction delays
Measured: 30 days
Risk factors associated with cardiovascular disease
Risk factors associated with cardiovascular disease including obesity (BMI and BSA calculations using height and weight) and blood pressure, along with personal and familial medical history.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start14 Jul 2021
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe 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
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- E. Lee Rice, MD, Principal investigator, Lifewellness Institute, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009589
- Sponsor's protocol ID
- 2021-07
- Acronym
- HUDDLE
- Status last verified
- Jan 2023
- First submitted
- 4 Aug 2021
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okoh AK, Amponsah MKD, Cheffet-Walsh S, Patel M, Carfagno D, Linton D, Dimeff R, Braunreiter D, Harrington P, Brennan FH Jr, Kavinsky C, Everett M, Park B, Gunnarsson M, Snowden S, Mootz L, Koepnick T, Wheeler J, Clarke SE, Prince H, Sannino A, Grayburn P, Rice EL. Prevalence of Cardiovascular Disease and Risk Factors Among Former National Football League Players. J Am Coll Cardiol. 2024 May 14;83(19):1827-1837. doi: 10.1016/j.jacc.2024.03.371. Epub 2024 Apr 7.
PubMed 38593943
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HUDDLE: Heart Health: Understanding & Diagnosing Disease by Leveraging Echocardiograms
- ClinicalTrials.gov ID
- NCT05009589
- Acronym / sponsor ID
- HUDDLE / 2021-07
- Conditions
- Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 17 Aug 2021 (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.
This study will screen for the presence of cardiovascular disease and provide education about the signs and symptoms of cardiovascular disease and heart disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will include participants identified at pre-planned screening events for cardiovascular disease who provide informed consent.
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
Abnormal structural heart findings
Time frame: 30 days
The number of patients with abnormal structural heart findings as identified by echocardiography
Abnormal electrocardiography findings
Time frame: 30 days
The number of patients with abnormal electrocardiography findings such as rhythm disturbances, bundle branch or fascicular block, or other conduction delays
Risk factors associated with cardiovascular disease
Time frame: 30 days
Risk factors associated with cardiovascular disease including obesity (BMI and BSA calculations using height and weight) and blood pressure, along with personal and familial medical history.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Derived from this study: PubMed 38593943Okoh AK, Amponsah MKD, Cheffet-Walsh S, Patel M, Carfagno D, Linton D, Dimeff R, Braunreiter D, Harrington P, Brennan FH Jr, Kavinsky C, Everett M, Park B, Gunnarsson M, Snowden S, Mootz L, Koepnick T, Wheeler J, Clarke SE, Prince H, Sannino A, Grayburn P, Rice EL. Prevalence of Cardiovascular Disease and Risk Factors Among Former National Football League Players. J Am Coll Cardiol. 2024 May 14;83(19):1827-1837. doi: 10.1016/j.jacc.2024.03.371. Epub 2024 Apr 7.
- 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. This study is not recruiting at the moment.
E. Lee Rice, MD principal investigator
Lifewellness Institute, San Diego, CA
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 Cardiovascular Diseases and Heart Diseases, run by Edwards Lifesciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Jan 2023. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Abnormal structural heart findings (time frame: 30 days). The study lists 3 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 NCT05009589, which also lists 1 linked publication.
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 5 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.