Trial Outcomes & Findings for Measuring Cardiovascular Performance and Blood Flow Using Common But Never Compared Methods. (NCT NCT04553484)

Results Overview

The feasibility of performing three common tests, Echocardiography (Echo), Brain Natriuretic Peptide (BNP) and volume plethysmography (VP), in the same subject was assessed. Each of the 657 participants were submitted to a brief non-invasive blood flow and cardiac performance test (plethysmography (VP) and Echocardiography (Echo)). Each of the 236 participants were subject to blood drawn test, Brain Natriuretic Peptide (BNP).

Recruitment status

COMPLETED

Target enrollment

657 participants

Primary outcome timeframe

Baseline

Results posted on

2024-07-03

Participant Flow

The Protocol was amended to include measurement of Brain Natriuretic Peptide (BNP) later in the study.

Participant milestones

Participant milestones
Measure	All Subjects Enrolled. 1 day for the collection of the test results of the 657 participants was performed for Echocardiography and Volume plethysmography tests. And 1 day for the collection of Brain Natriuretic peptide (BNP) tests results of 236 participants was conducted.
Overall Study STARTED	657
Overall Study COMPLETED	657
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Protocol was amended to include 236 participants for the measurement of Brain Natriuretic Peptide (BNP).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Measuring Cardiovascular Performance and Blood Flow. n=657 Participants Echocardiography (Echo), Brain Natriuretic Peptide (BNP), and volume plethysmography (VP) were performed in human subjects.
Age, Continuous	61.5 years STANDARD_DEVIATION 11.76 • n=657 Participants • The Protocol was amended to include 236 participants for the measurement of Brain Natriuretic Peptide (BNP).
Sex/Gender, Customized Male	379 Participants n=657 Participants
Sex/Gender, Customized Female	276 Participants n=657 Participants
Sex/Gender, Customized Not Recorded	2 Participants n=657 Participants
Region of Enrollment United States	657 Participants n=657 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All subjects could safely do the Echo and VP tests, and after the protocol was amended, 100% of subjects could safely do the BNP as well. The quality of the test results was not assessed in this study.

The feasibility of performing three common tests, Echocardiography (Echo), Brain Natriuretic Peptide (BNP) and volume plethysmography (VP), in the same subject was assessed. Each of the 657 participants were submitted to a brief non-invasive blood flow and cardiac performance test (plethysmography (VP) and Echocardiography (Echo)). Each of the 236 participants were subject to blood drawn test, Brain Natriuretic Peptide (BNP).

Outcome measures

Outcome measures
Measure	Echo, Volume Plethysmography n=657 Participants All subjects could safely do the Echocardiography (Echo) and volume plethysmography (VP) tests, and after the protocol was amended, 100% of subjects could safely do the Brain Natriuretic Peptide (BNP) as well. The quality of the test results was not assessed in this study.	Brain Natriuretic Peptide (BNP) n=236 Participants 236 subjects of the 657 subjects could safely do the Brain Natriuretic Peptide (BNP) tests. The quality of the test results was not assessed in this study.
Feasibility of Performing Echo, BNP, and VP on Human Subjects.	657 Participants	236 Participants

POST_HOC outcome

Timeframe: Baseline

Population: All subjects (657), adults male and female, safely had the Echo and VP tests, and after the protocol was amended, to include the Brain Natriuretic Peptide (BNP) test results of a subset of 236 participants.

An Ultrasound scan and a measurement of natriuretic peptides (BNP) in the blood were used to compute Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Global Longitudinal Strain (GLS) to determine a diagnosis of Heart Failure. Theses results were compared to the results of QuantaFlo, which automatically grades the measurement results as typical for heart failure or normal. Each of the 657 participants were submitted to a brief non-invasive blood flow and cardiac performance test. A subset of 236 participants were subject to blood drawn test, Brain Natriuretic Peptide (BNP).

Outcome measures

Outcome measures
Measure	Echo, Volume Plethysmography n=657 Participants All subjects could safely do the Echocardiography (Echo) and volume plethysmography (VP) tests, and after the protocol was amended, 100% of subjects could safely do the Brain Natriuretic Peptide (BNP) as well. The quality of the test results was not assessed in this study.	Brain Natriuretic Peptide (BNP) n=236 Participants 236 subjects of the 657 subjects could safely do the Brain Natriuretic Peptide (BNP) tests. The quality of the test results was not assessed in this study.
Measurement Cardiovascular Test Performance Results and Blood Flow of Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Global Longitudinal Strain (GLS). Male	379 Participants	177 Participants
Measurement Cardiovascular Test Performance Results and Blood Flow of Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Global Longitudinal Strain (GLS). Female	276 Participants	59 Participants
Measurement Cardiovascular Test Performance Results and Blood Flow of Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Global Longitudinal Strain (GLS). Not recorded	2 Participants	0 Participants

Adverse Events

Measuring Cardiovascular Performance and Blood Flow.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gena Parker

Semler Scientific

Phone: 669-230-2729

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER