Heart FailureADOPTSNCT05641675
Non-invasive Pulmonary Artery Prediction (ADOPTS)
An observational study of Heart Failure and Pulmonary Arterial Hypertension, run by Silverleaf Medical Sciences INC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Failure, Pulmonary Arterial Hypertension
- What is being tested?
- right heart catheterization
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Loma Linda Veterans Administration Healthcare System
Loma Linda, California, 92357
Jay Patel
About this study
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
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.
Read the detailed 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.
- Conditions
- Heart Failure, Pulmonary Arterial Hypertension
- Being tested
- right heart catheterization
- Keywords
- Pulmonary artery pressure, Electrocardiogram, Heart failure, Machine Learning
- Medical subject headings
- Heart Failure, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
right heart catheterizationDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: right heart catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the Swan-Ganz catheter obtains the pulmonary artery pressures for a minimum of 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Feb 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Silverleaf Medical Sciences INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VA Loma Linda Health Care System
- Responsible party
- Sponsor
- Investigators
- Jay Patel, Principal investigator, Loma Linda Veterans Administration Healthcare SystemIslam Abudayyeh, Study director, Silverleaf Medical Sciences INCJianwei Zheng, Ph.D., Study chair, Silverleaf Medical Sciences INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641675
- Sponsor's protocol ID
- ADOPTS_VALL
- Acronym
- ADOPTS
- Status last verified
- Nov 2022
- First submitted
- 29 Nov 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36093166
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05641675
- Acronym / sponsor ID
- ADOPTS / ADOPTS_VALL
- Conditions
- Heart Failure, Pulmonary Arterial Hypertension
- Keywords
- Pulmonary artery pressure, Electrocardiogram, Heart failure, Machine Learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Silverleaf Medical Sciences INCIndustry (pharma, biotech, devices)
- Collaborators
- VA Loma Linda Health Care System
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| right heart catheterization cohort | – | Diagnostic Test: right heart catheterizationThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| right heart catheterizationConnect 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 | Diagnostic test | right heart catheterization cohort |
Primary outcome
Major Outcome
Time frame: the Swan-Ganz catheter obtains the pulmonary artery pressures for a minimum of 5 minutes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Results publication: PubMed 36093166Zheng 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Patel principal investigator
Loma Linda Veterans Administration Healthcare System
Islam Abudayyeh study director
Silverleaf Medical Sciences INC
Jianwei Zheng, Ph.D. study chair
Silverleaf Medical Sciences INC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Pulmonary Arterial Hypertension, run by Silverleaf Medical Sciences INC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianwei Zheng, Ph.D. (9492398388, info@slmedsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Outcome (time frame: the Swan-Ganz catheter obtains the pulmonary artery pressures for a minimum of 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05641675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.