Cardiogenic ShockNCT07402018
Intra-aortic Balloon Counterpulsation (IABC) Compliance
An observational study of Cardiogenic Shock and IABC Procedure, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The investigators intend to study how baseline arterial compliance (as defined by stroke volume/pulse pressure) influences the clinical success of intraaortic balloon counterpulsation (IABC) in patients with cardiogenic shock (CS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, IABC Procedure, Intraaortic Balloon Counterpulsation (IABC)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2026to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiogenic shock patients undergoing Intra-aortic Balloon Counterpulsation
Who may be able to join
- Age ≥18 years old
- Cardiogenic shock
- Undergoing Intra-aortic Balloon Counterpulsation (IABC) as part of clinical care
- Able to provide consent or have power of attorney or next of kin provide consent
Who cannot join
- Age <18 years old
- Unable to consent or does not have power of attorney or next of kin to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Matthew S Delfiner, DO, MS contact
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Elizabeth Westburg, MS, 267-872-1871, elizabeth.westburg@jefferson.edu
Matthew S Delfiner, DO, MS
About this study
Official title: Arterial Compliance as a Predictor of Clinical Outcomes With Intra-aortic Balloon Counterpulsation: A Prospective Observational Pilot Study
The investigators intend to study how baseline arterial compliance (as defined by stroke volume/pulse pressure) influences the clinical success of intraaortic balloon counterpulsation (IABC) in patients with cardiogenic shock (CS). The investigators aim to compare clinical outcomes in CS patients requiring IABC with normal compliance versus low compliance. The study will enroll patients undergoing IABC that are clinically indicated. Baseline hemodynamic measurements will be obtained and then patients would be stratified based on their compliance. Post IABC, serial hemodynamic measurements will be obtained and compared between groups. Patients will continue to be followed longitudinally until the IABC has been discontinued for any reason. The proposed study will yield results that will aid in developing a larger clinical trial and ultimately assist clinicians in determining if IABC is appropriate therapy for patients in cardiogenic shock.
Read the detailed description
This study will focus on patients in cardiogenic shock (CS) that will be undergoing clinically indicated intraaortic balloon counterpulsation (IABC) insertion and right heart catheterization. Prior to IABC insertion a patient will have their clinically indicated right heart catheterization. The investigators will record these baseline hemodynamic parameters, including (but not limited to) stroke volume and arterial pulse pressure.
After IABC insertion is completed, repeat hemodynamic measurements will be obtained approximately 30 minutes later. Repeat hemodynamic measurements will be recorded at approximately 3-6 hours following the procedure, and 24 hours following the procedure. The act of recording hemodynamic measurements is part of the usual clinical management of patients with IABC.
The patients will continue be followed longitudinally until their IABC course has completed, either due to resolution of CS, exchange for a separate device, heart transplantation, durable Left Ventricular Assist Device (LVAD) implant, or patient death.
The investigators hypothesize that patients with low arterial compliance will have greater improvements in cardiac output and cardiac filling pressures compared to patients with normal compliance. The specific aims are to (1) compare hemodynamic changes with IABC in cardiogenic shock patients with low compliance vs those with normal compliance and (2) to determine a cutoff value of compliance that can be used for future larger clinical trials.
The proposed study will yield results that will aid in developing a larger clinical trial and ultimately assist clinicians in determining if IABC is appropriate therapy for patients in cardiogenic shock.
- Keywords
- Cardiogenic shock
- Medical subject headings
- Shock, Cardiogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output (L/min)
Measured: 24 hours
Secondary outcomes (72)
Systolic Blood Pressure (mmHg)
Measured: 30 minutes
Pulmonary Artery Oxygen Saturation (%)
Measured: 24 hours
Ultimate Disposition
Hospital death
Measured: Longitudinal Follow-Up (approximately 3 months)
Total Bilirubin (mg/dL)
participant laboratory value
Measured: 24 hours
ALT (U/L)
participant laboratory value
Measured: 24 hours
AST (U/L)
participant laboratory value
Measured: 24 hours
Creatine Clearance/GFR
Measured: 24 hours
Creatine (mg/dL)
participant laboratory value
Measured: 24 hours
Lactate millimoles per liter (mmol/L)
participant laboratory value
Measured: 24 hours
Pulmonary Artery Compliance (mmHg)
Measured: 24 hours
Right Ventricular Stroke Work Index (g·m-²·beat-¹)
Measured: 24 hours
Pulmonary Artery Pulsatility Index (PAPi)
calculated measurement
Measured: 24 hours
Pulmonary Vascular Resistance (dynes/cm⁵)
Measured: 24 hours
Systemic Vascular Resistance (mmHg/L/min)
Measured: 24 hours
Pulmonary Capillary Wedge Pressure (mmHg)
Measured: 24 hours
Diastolic Pulmonary Arterial Pressure (mmHg)
Measured: 24 hours
Systolic Pulmonary Artery Pressure (mmHg)
Measured: 24 hours
Right Atrium Pressure (mmHg)
report measurement
Measured: 24 hours
Aortic Pulsatility Index (API)
calculated measurement
Measured: 24 hours
Cardiac Power Input (W/m²)
Measured: 24 hours
Cardiac Power Output (Watts)
Measured: 24 hours
Stroke Volume (mL)
Measured: 24 hours
Cardiac Index (L/min/m²)
Measured: 24 hours
Heart Rhythm
Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other
Measured: 24 hours
Heart Rate (beats per minute)
Measured: 24 hours
Mean Arterial Pressure (mmHg)
Measured: 24 hours
Diastolic Blood Pressure (mmHg)
Measured: 24 hours
Systolic Blood Pressure (mmHg)
Measured: 24 hours
Pulmonary Artery Compliance (mmHg)
Measured: 3-6 hours
Right Ventricular Stroke Work Index (g·m-²·beat-¹)
Measured: 3-6 hours
Pulmonary Artery Pulsatility Index (PAPi)
calculated measurement
Measured: 3-6 hours
Pulmonary Vascular Resistance (dynes/cm⁵)
Measured: 3-6 hours
Systemic Vascular Resistance (mmHg/L/min)
Measured: 3-6 hours
Pulmonary Capillary Wedge Pressure (mmHg)
Measured: 3-6 hours
Diastolic Pulmonary Arterial Pressure (mmHg)
Measured: 3-6 hours
Systolic Pulmonary Artery Pressure (mmHg)
Measured: 3-6 hours
Right Atrium Pressure (mmHg)
report measurement
Measured: 3-6 hours
Aortic Pulsatility Index (API)
calculated measurement
Measured: 3-6 hours
Cardiac Power Input (W/m²)
Measured: 3-6 hours
Cardiac Power Output (Watts)
Measured: 3-6 hours
Stroke Volume (mL)
Measured: 3-6 hours
Cardiac Index (L/min/m²)
Measured: 3-6 hours
Cardiac Output (L/min)
Measured: 3-6 hours
Pulmonary Artery Oxygen Saturation (%)
Measured: 3-6 hours
Heart Rhythm
Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other
Measured: 3-6 hours
Heart Rate (beats per minute)
Measured: 3-6 hours
Mean Arterial Pressure (mmHg)
Measured: 3-6 hours
Diastolic Blood Pressure (mmHg)
Measured: 3-6 hours
Systolic Blood Pressure (mmHg)
Measured: 3-6 hours
Pulmonary Artery Compliance (mmHg)
Measured: 30 minutes
Right Ventricular Stroke Work Index (g·m-²·beat-¹)
Measured: 30 minutes
Pulmonary Artery Pulsatility Index (PAPi)
calculated measurement
Measured: 30 minutes
Pulmonary Vascular Resistance (dynes/cm⁵)
Measured: 30 minutes
Systemic Vascular Resistance (mmHg/L/min)
Measured: 30 minutes
Pulmonary Capillary Wedge Pressure (mmHg)
Measured: 30 minutes
Diastolic Pulmonary Arterial Pressure (mmHg)
Measured: 30 minutes
Systolic Pulmonary Artery Pressure (mmHg)
Measured: 30 minutes
Right Atrium Pressure (mmHg)
report measurement
Measured: 30 minutes
Aortic Pulsatility Index (API)
calculated measurement
Measured: 30 minutes
Cardiac Power Input (W/m²)
Measured: 30 minutes
Stroke Volume (mL)
Measured: 30 minutes
Cardiac Power Output (Watts)
Measured: 30 minutes
Cardiac Index (L/min/m²)
Measured: 30 minutes
Cardiac Output (L/min)
Measured: 30 minutes
Pulmonary Artery Oxygen Saturation (%)
Measured: 30 minutes
Heart Rhythm
Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other
Measured: 30 minutes
Heart Rate (beats per minute)
Measured: 30 minutes
Mean Arterial Pressure (mmHg)
Measured: 30 minutes
Diastolic Blood Pressure (mmHg)
Measured: 30 minutes
Ultimate Disposition
Heart recovery with discharge (alive)
Measured: Longitudinal Follow-Up (approximately 3 months)
Ultimate Disposition
Left Ventricular Assist Device (LVAD)
Measured: Longitudinal Follow-Up (approximately 3 months)
Ultimate Disposition
Transplant
Measured: Longitudinal Follow-Up (approximately 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start27 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Delfiner, Thomas Jefferson University
- Investigators
- Matthew S Delfiner, DO, MS, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402018
- Sponsor's protocol ID
- 2025-0678
- Status last verified
- Nov 2025
- First submitted
- 9 Jan 2026
- Last updated
- 11 Feb 2026
- 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Compliance as a Predictor of Clinical Outcomes With Intra-aortic Balloon Counterpulsation: A Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT07402018
- Acronym / sponsor ID
- 2025-0678
- Keywords
- Cardiogenic shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Feb 2026 (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 investigators intend to study how baseline arterial compliance (as defined by stroke volume/pulse pressure) influences the clinical success of intraaortic balloon counterpulsation (IABC) in patients with cardiogenic shock (CS). The investigators aim to compare clinical outcomes in CS patients requiring IABC with normal compliance versus low compliance. The study will enroll patients undergoing IABC that are clinically indicated. Baseline hemodynamic measurements will be obtained and then patients would be stratified based on their compliance. Post IABC, serial hemodynamic measurements will be obtained and compared between groups. Patients will continue to be followed longitudinally until the IABC has been discontinued for any reason. The proposed study will yield results that will aid in developing a larger clinical trial and ultimately assist clinicians in determining if IABC is appropriate therapy for patients in cardiogenic shock.
Detailed description
This study will focus on patients in cardiogenic shock (CS) that will be undergoing clinically indicated intraaortic balloon counterpulsation (IABC) insertion and right heart catheterization. Prior to IABC insertion a patient will have their clinically indicated right heart catheterization. The investigators will record these baseline hemodynamic parameters, including (but not limited to) stroke volume and arterial pulse pressure.
After IABC insertion is completed, repeat hemodynamic measurements will be obtained approximately 30 minutes later. Repeat hemodynamic measurements will be recorded at approximately 3-6 hours following the procedure, and 24 hours following the procedure. The act of recording hemodynamic measurements is part of the usual clinical management of patients with IABC.
The patients will continue be followed longitudinally until their IABC course has completed, either due to resolution of CS, exchange for a separate device, heart transplantation, durable Left Ventricular Assist Device (LVAD) implant, or patient death.
The investigators hypothesize that patients with low arterial compliance will have greater improvements in cardiac output and cardiac filling pressures compared to patients with normal compliance. The specific aims are to (1) compare hemodynamic changes with IABC in cardiogenic shock patients with low compliance vs those with normal compliance and (2) to determine a cutoff value of compliance that can be used for future larger clinical trials.
The proposed study will yield results that will aid in developing a larger clinical trial and ultimately assist clinicians in determining if IABC is appropriate therapy for patients in cardiogenic shock.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiogenic shock patients undergoing Intra-aortic Balloon Counterpulsation
Key inclusion criteria (4 listed)
- Age ≥18 years old
- Cardiogenic shock
- Undergoing Intra-aortic Balloon Counterpulsation (IABC) as part of clinical care
- Able to provide consent or have power of attorney or next of kin provide consent
Key exclusion criteria (2 listed)
- Age <18 years old
- Unable to consent or does not have power of attorney or next of kin to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac Output (L/min)
Time frame: 24 hours
72 secondary outcomes
Systolic Blood Pressure (mmHg)
Time frame: 30 minutes
Pulmonary Artery Oxygen Saturation (%)
Time frame: 24 hours
Ultimate Disposition
Time frame: Longitudinal Follow-Up (approximately 3 months)
Total Bilirubin (mg/dL)
Time frame: 24 hours
ALT (U/L)
Time frame: 24 hours
AST (U/L)
Time frame: 24 hours
Creatine Clearance/GFR
Time frame: 24 hours
Creatine (mg/dL)
Time frame: 24 hours
Lactate millimoles per liter (mmol/L)
Time frame: 24 hours
Pulmonary Artery Compliance (mmHg)
Time frame: 24 hours
Right Ventricular Stroke Work Index (g·m-²·beat-¹)
Time frame: 24 hours
Pulmonary Artery Pulsatility Index (PAPi)
Time frame: 24 hours
Pulmonary Vascular Resistance (dynes/cm⁵)
Time frame: 24 hours
Systemic Vascular Resistance (mmHg/L/min)
Time frame: 24 hours
Pulmonary Capillary Wedge Pressure (mmHg)
Time frame: 24 hours
Diastolic Pulmonary Arterial Pressure (mmHg)
Time frame: 24 hours
Systolic Pulmonary Artery Pressure (mmHg)
Time frame: 24 hours
Right Atrium Pressure (mmHg)
Time frame: 24 hours
Aortic Pulsatility Index (API)
Time frame: 24 hours
Cardiac Power Input (W/m²)
Time frame: 24 hours
Cardiac Power Output (Watts)
Time frame: 24 hours
Stroke Volume (mL)
Time frame: 24 hours
Cardiac Index (L/min/m²)
Time frame: 24 hours
Heart Rhythm
Time frame: 24 hours
Heart Rate (beats per minute)
Time frame: 24 hours
Mean Arterial Pressure (mmHg)
Time frame: 24 hours
Diastolic Blood Pressure (mmHg)
Time frame: 24 hours
Systolic Blood Pressure (mmHg)
Time frame: 24 hours
Pulmonary Artery Compliance (mmHg)
Time frame: 3-6 hours
Right Ventricular Stroke Work Index (g·m-²·beat-¹)
Time frame: 3-6 hours
Pulmonary Artery Pulsatility Index (PAPi)
Time frame: 3-6 hours
Pulmonary Vascular Resistance (dynes/cm⁵)
Time frame: 3-6 hours
Systemic Vascular Resistance (mmHg/L/min)
Time frame: 3-6 hours
Pulmonary Capillary Wedge Pressure (mmHg)
Time frame: 3-6 hours
Diastolic Pulmonary Arterial Pressure (mmHg)
Time frame: 3-6 hours
Systolic Pulmonary Artery Pressure (mmHg)
Time frame: 3-6 hours
Right Atrium Pressure (mmHg)
Time frame: 3-6 hours
Aortic Pulsatility Index (API)
Time frame: 3-6 hours
Cardiac Power Input (W/m²)
Time frame: 3-6 hours
Cardiac Power Output (Watts)
Time frame: 3-6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- 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.
Matthew S Delfiner, DO, MS contact
Matthew S Delfiner, DO, MS principal investigator
Thomas Jefferson University
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 Cardiogenic Shock and IABC Procedure, run by Thomas Jefferson University 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 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth R Westburg, MS (215-955-2050, elizabeth.westburg@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (L/min) (time frame: 24 hours). 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 11 Feb 2026.