HUDDLE: Heart Health: Understanding & Diagnosing Disease by Leveraging Echocardiograms

Cardiovascular Diseases Clinical Trial

— HUDDLE  

Official title:

HUDDLE: Heart Health: Understanding & Diagnosing Disease by Leveraging Echocardiograms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05009589
• Other study ID #: 2021-07
• Status: Completed
• Start date: July 14, 2021
• Est. completion date: October 7, 2022

Study information

• Verified date: January 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: October 7, 2022
• Est. primary completion date: October 7, 2022
• Gender: All
• Age group: 50 Years and older

Eligibility

Key Eligibility Criteria:

1. at least 50 years of age on the day of the screening event

2. informed of the nature of the study, agrees to its provisions, and has provided written informed consent

3. does not have any conditions that would interfere with obtaining an echocardiogram of the heart

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Locations

Country	Name	City	State
United States	Lifewellness Institute	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal structural heart findings	The number of patients with abnormal structural heart findings as identified by echocardiography	30 days
Primary	Abnormal electrocardiography findings	The number of patients with abnormal electrocardiography findings such as rhythm disturbances, bundle branch or fascicular block, or other conduction delays	30 days
Primary	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.	30 days