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Non-invasive Pulmonary Artery Prediction (ADOPTS)

Study Purpose

A proprietary machine-learning algorithm has been developed to model continuous pulmonary artery pressure (PAP), a physiologic marker of cardiopulmonary function. The algorithm was developed from PAP recordings obtained during invasive right heart catheterization. The study will evaluate whether this algorithm can perform as well when embedded into a non-invasive wearable device that records EKG, heart sounds, and thoracic impedance has yet to be established.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 20 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Written informed consent and authorization to use and disclose health information.
  • - 20 years of age or older.
  • - Diagnosis of HF for >3 months, with preserved or reduced left ventricular ejection fraction (LVEF).
  • - Female subjects of childbearing age with a negative urine or serum pregnancy test at the time of the right heart cauterization procedure and trial.

Exclusion Criteria:

  • - Active infection.
  • - Unable to tolerate a right heart catheterization (RHC), in the investigator's opinion.
  • - Implantation of cardiac resynchronization therapy (CRT)<3 months before enrollment.
  • - Enrolled in concurrent studies that may confound the results of this study.
  • - Clinical condition that would not allow them to complete the study, in the investigator's opinion.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05641675
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Silverleaf Medical Sciences INC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jay PatelIslam AbudayyehJianwei Zheng, Ph.D.
Principal Investigator Affiliation Loma Linda Veterans Administration Healthcare SystemSilverleaf Medical Sciences INCSilverleaf Medical Sciences INC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry, U.S. Fed
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Heart Failure, Pulmonary Arterial Hypertension
Additional Details

A prototype device will be supplied by Silverleaf Medical Science (Redlands, CA) to record these signals. This study will take place at Loma Linda VA, in the cardiac catheterization lab as an add-on to clinically-indicated right heart catheterizations, and under the supervision of heart failure and interventional cardiologists. The investigators will screen and enroll 20 Veterans who consent to participate in the study. Veterans who decline to consent and vulnerable populations will be excluded from the study. The investigators will obtain simultaneous recordings from the prototype device (EKG, heart sounds, and thoracic impedance) and from the PAP catheter , both at rest (5 minutes), and in response to physiological maneuvers: hand grip, passive leg raise, and Valsalva (1 minute recordings with 1-minute breaks). De-identified recordings from the prototype device will be shared with the team at Silverleaf Medical Science to derive a computed PAP. The investigators will test the hypothesis that computed PAP is no different than measured PAP. If the algorithm can produce a computed PAP with high accuracy,'[it would be the first wearable system to non-invasively report PAP.

Arms & Interventions

Arms

: right heart catheterization cohort

The study investigators will screen up to 50 Veterans undergoing right heart catheterization for clinical indications with the intention to consent up to 20 Veterans. Veterans will be screened by study investigators. Veterans who decline to consent and vulnerable populations (pregnant, incapacitated, incarcerated) will be excluded from the study.

Interventions

Diagnostic Test: - right heart catheterization

Connect to a heart monitor to record heart rate, blood pressure and blood oxygen levels Place sterile sheets on chest and neck (or groin area) Clean the skin over the neck or groin Give local anaesthetic to numb the area (this may sting a little when it is given) Gently pass a catheter into a vein to the heart Record pressure readings from the heart chambers and lungs Give medication, depending on heart's pressure readings Remove the catheter and apply pressure where it was inserted

Contact a Trial Team

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Loma Linda, California

Status

Address

Loma Linda Veterans Administration Healthcare System

Loma Linda, California, 92357

Site Contact

Jay Patel

info@slmedsci.com

9492398388

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