D001775 Clinical Trial - Measuring Cardiovascular NCT04553484

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

The aims of this study are to measure cardiovascular performance and blood flow using common but never compared methods.

Recruitment information / eligibility
Status	Completed
Enrollment	657
Est. completion date	January 14, 2022
Est. primary completion date	December 29, 2021
Accepts healthy volunteers	No
Gender	All
Age group	45 Years and older
Eligibility	Inclusion Criteria: - At least 50 Patients from New York Heart Association (NYHA) Class 1 (One or more AHA Risk Factors, asymptomatic), =75% (36) Male, =25% (12) Female - At least 50 Patients from NYHA Class 2 (symptomatic), =75% (36) Male, =25% (12) Female Exclusion Criteria: - Subjects on mechanical ventilation. - Subjects who require decisions by a medical power of attorney. - Subjects unable to safely perform forced expiration. - Subjects with known technically difficult (TDS) trans-thoracic echocardiographic windows.

Diagnostic Test:
• Measuring cardiovascular performance and blood flow
Measuring cardiovascular performance and blood flow

Locations
Country	Name	City	State
United States	JF Southwest Heart Clinic, P.A.	Houston	Texas
United States	Integrated Cardiology Group, LLC, d/b/a Bryan Heart	Lincoln	Nebraska
United States	Middle Georgia Heart and Vascular Center	Macon	Georgia

Sponsors *(1)*
Lead Sponsor	Collaborator
Semler Scientific

United States,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Blood flow measurement	A Clinician will use a fingertip sensor and expiration device to measure blood flow in a patient by Volume Plethysmography.	Baseline
Secondary	Cardiac performance measurement	A Cardiac Echo Technician will measure cardiac performance in a patient using Echocardiography.	through study completion, an average of 10 weeks