Heart FailureKT-KCGNCT03821766
Haemodynamic Abnormalities Recorded With Cardiac Catheterization Along With Body's Surface Micro-accelerometers (KT-KCG)
An observational study of Heart Failure and Pulmonary Hypertension, run by Erasme University Hospital.
Trial summary
The ballistocardiography (BCG) and the seismocardiography (SCG) are old techniques recording the vibrations at the skin level generated by the acceleration and displacement of the blood and cardiac mass at each cardiac contraction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Pulmonary Hypertension
- What is being tested?
- Ballistocardiography and seismocardiography
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 30 Dec 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from heart failure and undergoing a planned cardiac catheterization as required by their medical condition will be asked to participate to the study. The inclusion criteria include heart failure regardless of its etiology. Patients with a left ventricle assistance device will not be enrolled because the high-frequency accelerations generated by the mechanical device and transmitted to the skin level will likely hamper the ballisto- and seismocardiographic signal.
Who may be able to join
- Age 18 y.o. to 80 y.o.
- Heart failure
Who cannot join
- Left ventricle assistance device
- Refused participation
About this study
Official title: Do Abnormal Hemodynamic Features Generate Relevant Reactions and Vibrations at the Skin Level When Recorded by Micro Accelerometers
The ballistocardiography (BCG) and the seismocardiography (SCG) are old techniques recording the vibrations at the skin level generated by the acceleration and displacement of the blood and cardiac mass at each cardiac contraction. The former records the acceleration near the subject's center of mass, the latter at the local chest wall. So far, the unclear physiological origin of those acceleration signals has led to important ambiguities in their scientific and clinical interpretation. Therefore, several ongoing studies would aim to highlight the physiological genesis of those acceleration-induced signals.
Indeed, the main objective of this study is to correlate the BCG and SCG signals recorded at the body surface with several haemodynamic parameters recorded invasively during a cardiac catheterisation, pulmonary pressure, wedge pressure, cardiac output to cite a few.
Read the detailed description
Patients suffering from severe heart failure regardless of the etiology will undergo a cardiac catheterization as required by their medical condition.
The SCG and BCG signals will be recorded simultaneously to the catheterization by the mean of an unintrusive and friendly device consisting of two houses, the first one placed on sternum and the second one in the lumbar column. The device will record a continuous tracing synchronized with the intracavitary pressure profiles recorded during the invasive procedure.
- Conditions
- Heart Failure, Pulmonary Hypertension
- Being tested
- Ballistocardiography and seismocardiography
- Keywords
- Intracavitary pressure, Ballistocardiography, Seismocardiography, Microaccelerations, Kinetic energy
- Medical subject headings
- Heart Failure, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ballistocardiography and seismocardiographyDevice
SCG and BCG signals will be recorded by the mean of an unobtrusive and friendly device consisting of two houses, the first one placed on the sternum and the second one place on the lumbar region near the subject's center of mass. The signal will be transferred to a tablet by Bluetooth and tracings will be analysed automatically with Matlab. The SCG+BCG signals are synchronized to the intracardiac pressure tracings in order to allow a comparative interpretation between the two tracings.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure | Patients suffering from heart failure regardless to the etiology will undergo cardiac catheterization according to their medical condition. the SCG and BCG signals will be recorded along with the intracavitary pressure profiles detected invasively with the cardiac catheterization. Receives: Device: Ballistocardiography and seismocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Micro-accelerations recorded at the body's surface
Analysis of heart-induced velocities (m/s) by the means of micro-accelerometers and secondary computation of the kinetic energy (KE= 1/2 mv²) recorded with the seismocardiography and ballistocardiography at the skin level during cardiac catheterization.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Feb 2020
- Primary completion1 Sep 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Why it stopped: Technical failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821766
- Sponsor's protocol ID
- P2018/479
- Acronym
- KT-KCG
- Status last verified
- Aug 2020
- First submitted
- 11 Jan 2019
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Abnormal Hemodynamic Features Generate Relevant Reactions and Vibrations at the Skin Level When Recorded by Micro Accelerometers
- ClinicalTrials.gov ID
- NCT03821766
- Acronym / sponsor ID
- KT-KCG / P2018/479
- Conditions
- Heart Failure, Pulmonary Hypertension
- Keywords
- Intracavitary pressure, Ballistocardiography, Seismocardiography, Microaccelerations, Kinetic energy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Technical failure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 30 Jan 2019 (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.
The ballistocardiography (BCG) and the seismocardiography (SCG) are old techniques recording the vibrations at the skin level generated by the acceleration and displacement of the blood and cardiac mass at each cardiac contraction. The former records the acceleration near the subject's center of mass, the latter at the local chest wall. So far, the unclear physiological origin of those acceleration signals has led to important ambiguities in their scientific and clinical interpretation. Therefore, several ongoing studies would aim to highlight the physiological genesis of those acceleration-induced signals.
Indeed, the main objective of this study is to correlate the BCG and SCG signals recorded at the body surface with several haemodynamic parameters recorded invasively during a cardiac catheterisation, pulmonary pressure, wedge pressure, cardiac output to cite a few.
Detailed description
Patients suffering from severe heart failure regardless of the etiology will undergo a cardiac catheterization as required by their medical condition.
The SCG and BCG signals will be recorded simultaneously to the catheterization by the mean of an unintrusive and friendly device consisting of two houses, the first one placed on sternum and the second one in the lumbar column. The device will record a continuous tracing synchronized with the intracavitary pressure profiles recorded during the invasive procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure | – | Device: Ballistocardiography and seismocardiographyPatients suffering from heart failure regardless to the etiology will undergo cardiac catheterization according to their medical condition. the SCG and BCG signals will be recorded along with the intracavitary pressure profiles detected invasively with the cardiac catheterization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from heart failure and undergoing a planned cardiac catheterization as required by their medical condition will be asked to participate to the study. The inclusion criteria include heart failure regardless of its etiology. Patients with a left ventricle assistance device will not be enrolled because the high-frequency accelerations generated by the mechanical device and transmitted to the skin level will likely hamper the ballisto- and seismocardiographic signal.
Key inclusion criteria (2 listed)
- Age 18 y.o. to 80 y.o.
- Heart failure
Key exclusion criteria (2 listed)
- Left ventricle assistance device
- Refused participation
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 |
|---|---|---|
| Ballistocardiography and seismocardiographySCG and BCG signals will be recorded by the mean of an unobtrusive and friendly device consisting of two houses, the first one placed on the sternum and the second one place on the lumbar region near the subject's center of mass. The signal will be transferred to a tablet by Bluetooth and tracings will be analysed automatically with Matlab. The SCG+BCG signals are synchronized to the intracardiac pressure tracings in order to allow a comparative interpretation between the two tracings. | Device | Heart failure |
Primary outcome
Micro-accelerations recorded at the body's surface
Time frame: 6 months
Analysis of heart-induced velocities (m/s) by the means of micro-accelerometers and secondary computation of the kinetic energy (KE= 1/2 mv²) recorded with the seismocardiography and ballistocardiography at the skin level during cardiac catheterization.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Pulmonary Hypertension, run by Erasme University Hospital.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Micro-accelerations recorded at the body's surface (time frame: 6 months). 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 25 Aug 2020.