Non-invasive Pulmonary Artery Prediction (ADOPTS)

Heart Failure Clinical Trial

— ADOPTS  

Official title:

Feasibility Study to Determine if Novel Wearable Monitoring System and Machine-Learning Algorithm Can Model Continuous Pulmonary Artery Pressure Recordings in Human Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05641675
• Other study ID #: ADOPTS_VALL
• Status: Not yet recruiting
• Start date: February 1, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2022
• Source: Silverleaf Medical Sciences INC
• Contact: Jianwei Zheng, Ph.D.
• Phone: 9492398388
• Email: info[@]slmedsci.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: October 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Loma Linda Veterans Administration Healthcare System	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Silverleaf Medical Sciences INC	VA Loma Linda Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zheng J, Abudayyeh I, Mladenov G, Struppa D, Fu G, Chu H, Rakovski C. An artificial intelligence-based noninvasive solution to estimate pulmonary artery pressure. Front Cardiovasc Med. 2022 Aug 24;9:855356. doi: 10.3389/fcvm.2022.855356. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Outcome	The primary outcome of this study is to determine if a machine-learning algorithm with data from a wearable device can reproduce simultaneous PAP measurement obtained during right heart catheterization.	the Swan-Ganz catheter obtains the pulmonary artery pressures for a minimum of 5 minutes