Recruiting

Cardiovascular Assessment

Sponsor:

Semler Scientific

Code:

NCT07219693

Conditions

To Assess Cardiovascular Function

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

QuantaFlo HD

Study Details

Brief summary:

The primary aim of this validation protocol is to assess cardiovascular function through transthoracic echocardiography ("Echo") measurements and the QuantaFlo HD test measuring blood flow at the finger during a forced expiration ("FE"). The study examines whether Echo-measured GLS values greater than -16% correlate with abnormal responses during FE as measured by QuantaFlo HD.

Conditions

To Assess Cardiovascular Function

Study ID

NCT07219693

Start date

Aug 21, 2025

Status verified date

Oct, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male and female adult (≥ age 22) subjects with a minimum of 1 of the following:
  • A history of Cardiovascular Diseasei or PAD
  • Recorded history of at least two of the following
  • Hypertension
  • Diabetes
  • Hyperlipidemia

Exclusion Criteria:

  • Unable to safely perform a forced expiration, or unable to obtain a technically adequate FE test result
  • Subjects with a pacemaker or ICD with pacemaker function
  • Terminal advanced illness
  • Recent cardiothoracic surgery (within 12 months)
  • Retinal eye disease with anticoagulants
  • History of eye surgery, within 90 days
  • Uncontrolled hypertension >180 mmHg systolic pressure or >100 mmHg diastolic pressure
  • Subjects with severe tremors

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Interventions

QuantaFlo HD

blood flow at the finger during a forced expiration

Primary outcome measure

  • Sensitivity and Specificity [ Time Frame: From enrollment to the end of treatment is up to 1 week ]

Central Contacts and Locations

Central contacts

Gena Parker

669-230-2729gparker@semlerscientific.com

Locations

Pima Heart and Vascular

Recruiting

Tucson, Arizona, United States, 85741

Contacts

Monica Varela

520-975-6400Monica.Varela@usheartandvascular.com

Principal Investigator:

Thomas Waggoner

More Information

Sponsor

Semler Scientific

Last update posted

Oct 23, 2025

Last verified

Oct, 2025

Keywords

  • cardiovascular function
  • transthoracic echocardiography
  • global longitudinal strain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Semler Scientific on 2025-10-23.