Intra-aortic Balloon Counterpulsation (IABC) Compliance

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiogenic Shock; IABC Procedure; Intraaortic Balloon Counterpulsation (IABC)

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Elizabeth R Westburg, MS; Phone Number: 215-955-2050; Email: elizabeth.westburg@jefferson.edu
• Study Contact Backup: Name: Matthew S Delfiner, DO, MS; Phone Number: 215-955-2050

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Elizabeth Westburg, MS; Phone Number: 267-872-1871; Email: elizabeth.westburg@jefferson.edu
      • Principal Investigator: Matthew S Delfiner, DO, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cardiogenic shock patients undergoing Intra-aortic Balloon Counterpulsation

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Age <18 years old
• Unable to consent or does not have power of attorney or next of kin to consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiac Output (L/min)	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure (mmHg)		30 minutes
Pulmonary Artery Oxygen Saturation (%)		24 hours
Ultimate Disposition	Hospital death	Longitudinal Follow-Up (approximately 3 months)
Total Bilirubin (mg/dL)	participant laboratory value	24 hours
ALT (U/L)	participant laboratory value	24 hours
AST (U/L)	participant laboratory value	24 hours
Creatine Clearance/GFR		24 hours
Creatine (mg/dL)	participant laboratory value	24 hours
Lactate millimoles per liter (mmol/L)	participant laboratory value	24 hours
Pulmonary Artery Compliance (mmHg)		24 hours
Right Ventricular Stroke Work Index (g·m-²·beat-¹)		24 hours
Pulmonary Artery Pulsatility Index (PAPi)	calculated measurement	24 hours
Pulmonary Vascular Resistance (dynes/cm⁵)		24 hours
Systemic Vascular Resistance (mmHg/L/min)		24 hours
Pulmonary Capillary Wedge Pressure (mmHg)		24 hours
Diastolic Pulmonary Arterial Pressure (mmHg)		24 hours
Systolic Pulmonary Artery Pressure (mmHg)		24 hours
Right Atrium Pressure (mmHg)	report measurement	24 hours
Aortic Pulsatility Index (API)	calculated measurement	24 hours
Cardiac Power Input (W/m²)		24 hours
Cardiac Power Output (Watts)		24 hours
Stroke Volume (mL)		24 hours
Cardiac Index (L/min/m²)		24 hours
Heart Rhythm	Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other	24 hours
Heart Rate (beats per minute)		24 hours
Mean Arterial Pressure (mmHg)		24 hours
Diastolic Blood Pressure (mmHg)		24 hours
Systolic Blood Pressure (mmHg)		24 hours
Pulmonary Artery Compliance (mmHg)		3-6 hours
Right Ventricular Stroke Work Index (g·m-²·beat-¹)		3-6 hours
Pulmonary Artery Pulsatility Index (PAPi)	calculated measurement	3-6 hours
Pulmonary Vascular Resistance (dynes/cm⁵)		3-6 hours
Systemic Vascular Resistance (mmHg/L/min)		3-6 hours
Pulmonary Capillary Wedge Pressure (mmHg)		3-6 hours
Diastolic Pulmonary Arterial Pressure (mmHg)		3-6 hours
Systolic Pulmonary Artery Pressure (mmHg)		3-6 hours
Right Atrium Pressure (mmHg)	report measurement	3-6 hours
Aortic Pulsatility Index (API)	calculated measurement	3-6 hours
Cardiac Power Input (W/m²)		3-6 hours
Cardiac Power Output (Watts)		3-6 hours
Stroke Volume (mL)		3-6 hours
Cardiac Index (L/min/m²)		3-6 hours
Cardiac Output (L/min)		3-6 hours
Pulmonary Artery Oxygen Saturation (%)		3-6 hours
Heart Rhythm	Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other	3-6 hours
Heart Rate (beats per minute)		3-6 hours
Mean Arterial Pressure (mmHg)		3-6 hours
Diastolic Blood Pressure (mmHg)		3-6 hours
Systolic Blood Pressure (mmHg)		3-6 hours
Pulmonary Artery Compliance (mmHg)		30 minutes
Right Ventricular Stroke Work Index (g·m-²·beat-¹)		30 minutes
Pulmonary Artery Pulsatility Index (PAPi)	calculated measurement	30 minutes
Pulmonary Vascular Resistance (dynes/cm⁵)		30 minutes
Systemic Vascular Resistance (mmHg/L/min)		30 minutes
Pulmonary Capillary Wedge Pressure (mmHg)		30 minutes
Diastolic Pulmonary Arterial Pressure (mmHg)		30 minutes
Systolic Pulmonary Artery Pressure (mmHg)		30 minutes
Right Atrium Pressure (mmHg)	report measurement	30 minutes
Aortic Pulsatility Index (API)	calculated measurement	30 minutes
Cardiac Power Input (W/m²)		30 minutes
Stroke Volume (mL)		30 minutes
Cardiac Power Output (Watts)		30 minutes
Cardiac Index (L/min/m²)		30 minutes
Cardiac Output (L/min)		30 minutes
Pulmonary Artery Oxygen Saturation (%)		30 minutes
Heart Rhythm	Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other	30 minutes
Heart Rate (beats per minute)		30 minutes
Mean Arterial Pressure (mmHg)		30 minutes
Diastolic Blood Pressure (mmHg)		30 minutes
Ultimate Disposition	Heart recovery with discharge (alive)	Longitudinal Follow-Up (approximately 3 months)
Ultimate Disposition	Left Ventricular Assist Device (LVAD)	Longitudinal Follow-Up (approximately 3 months)
Ultimate Disposition	Transplant	Longitudinal Follow-Up (approximately 3 months)

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Matthew S Delfiner, DO, MS, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Cardiogenic shock
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Shock; Pathological Conditions, Signs and Symptoms; Shock, Cardiogenic
• Other Study ID Numbers: 2025-0678

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No