Congestive Heart FailureNCT04509089
Establishing Correlation Between Non-invasive Pulmonary Blood Pressure Readings and Swan-Ganz Results
A study testing Suremedix Device in people with Congestive Heart Failure, run by Suremedix Ltd at 1 site in Israel.
Trial summary
Pulmonary hypertension (PH) is prognostic indicator in heart failure patients for poor outcome, however, it is challenging for monitoring. The current study is designed to explore whether data generated using Suremedix Device including a pump and non-invasive sensors including, chest motion sensor… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Suremedix Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2020to 1 Mar 2021
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart Failure patient scheduled for right heart catheterization (Swan-Ganz)
- Age range: 18 - 80 years
- Pulmonary artery systolic pressure values ≤50 mmHg according to Swan - Ganz measurement
- Able and willing to sign informed consent
Who cannot join
- History or current diagnosis of asthma or any other significant pulmonary disease
- Jugular access site
- Atrial fibrillation
- Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation
- Requirement for any ventilator support (including CPAP or BPAP)
- Use of long-term oxygen therapy
Show all 19Show fewer
- Known upper airway obstruction
- Known susceptibility to pneumothorax or pneumothorax in the medical history
- Chest surgery or pacemaker implantation in the prior 6 months
- Significant primary valvular disease
- Major cardiovascular event within the prior 3 months
- Current heavy smoker (more than one pack per day)
- Any diagnosed respiratory tract infection (including upper respiratory tract), airway or lung disease or COPD exacerbation in the prior 3 months
- Female patient pregnant or breast-feeding or planning to be pregnant in the next year
- Diagnosis of Obstructive Sleep Apnea
- Unexplained muscle weakness. Unable to comfortably lie down for 30 minutes
- Current hospitalization due to CHF deterioration
- Patients with a Body Mass Index (BMI) ≥ 40kg/m2
- Any condition that the PI believes could interfere with the intent of the study or would make participation not in the best interest of the patient
Trial locations and contacts
1 site in 1 country.
About this study
Pulmonary hypertension (PH) is prognostic indicator in heart failure patients for poor outcome, however, it is challenging for monitoring. The current study is designed to explore whether data generated using Suremedix Device including a pump and non-invasive sensors including, chest motion sensor, photoplethysmography (PPG), and Electrocardiography (ECG), can be used to identify detectable oscillations that are correlated with the mean, the diastolic and the systolic pressure values of the pulmonary artery, as measured using the gold-standard Swan-Ganz method.
- Conditions
- Congestive Heart Failure
- Being tested
- Suremedix Device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suremedix DeviceDevice
Performing measurements using the Suremedix Device by applying gradually ascending air pressure to the subject lungs through a mouse piece while measuring respiratory chest motion, PPG and ECG.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Congestive heart failure patients scheduled for pulmonary artery catheterization (Swan-Ganz) Receives: Device: Suremedix Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure waveform
Correlation between specific changes observed in the pressure waveform recorded by the SureMedix Device and the mean, diastolic and systolic pressure values of the pulmonary artery as measured using the gold-standard Swan-Ganz method.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Dec 2020
- Primary completion29 Jan 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suremedix Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben Ben Avraham, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509089
- Sponsor's protocol ID
- CIP-001
- Status last verified
- Jul 2021
- First submitted
- 8 Aug 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Correlation Between Non-invasive Pulmonary Blood Pressure Readings and Swan-Ganz Results
- ClinicalTrials.gov ID
- NCT04509089
- Acronym / sponsor ID
- CIP-001
- Conditions
- Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Suremedix LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 11 Aug 2020 (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.
Pulmonary hypertension (PH) is prognostic indicator in heart failure patients for poor outcome, however, it is challenging for monitoring. The current study is designed to explore whether data generated using Suremedix Device including a pump and non-invasive sensors including, chest motion sensor, photoplethysmography (PPG), and Electrocardiography (ECG), can be used to identify detectable oscillations that are correlated with the mean, the diastolic and the systolic pressure values of the pulmonary artery, as measured using the gold-standard Swan-Ganz method.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Suremedix DeviceCongestive heart failure patients scheduled for pulmonary artery catheterization (Swan-Ganz) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Heart Failure patient scheduled for right heart catheterization (Swan-Ganz)
- Age range: 18 - 80 years
- Pulmonary artery systolic pressure values ≤50 mmHg according to Swan - Ganz measurement
- Able and willing to sign informed consent
Key exclusion criteria (19 listed)
- History or current diagnosis of asthma or any other significant pulmonary disease
- Jugular access site
- Atrial fibrillation
- Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation
- Requirement for any ventilator support (including CPAP or BPAP)
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 |
|---|---|---|
| Suremedix DevicePerforming measurements using the Suremedix Device by applying gradually ascending air pressure to the subject lungs through a mouse piece while measuring respiratory chest motion, PPG and ECG. | Device | Experimental |
Primary outcome
Pressure waveform
Time frame: 15 minutes
Correlation between specific changes observed in the pressure waveform recorded by the SureMedix Device and the mean, diastolic and systolic pressure values of the pulmonary artery as measured using the gold-standard Swan-Ganz method.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Ben Ben Avraham, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suremedix Device in people with Congestive Heart Failure, run by Suremedix Ltd at 1 site in Israel.
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 19 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: finished, as of the sponsor's last update on 4 Aug 2021. 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 Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure waveform (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2021.