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NCT Number: NCT07402018

Intra-aortic Balloon Counterpulsation (IABC) Compliance

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.

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Heart Diseases IABC Procedure Infarction Intraaortic Balloon Counterpulsation (IABC) Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location status: Recruiting

Location contact

Elizabeth Westburg, MS

CONTACT

[email protected]

267-872-1871

Matthew S Delfiner, DO, MS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cardiac Output (L/min)

    Time frame: 24 hours

Secondary outcomes

  1. Systolic Blood Pressure (mmHg)

    Time frame: 30 minutes

  2. Pulmonary Artery Oxygen Saturation (%)

    Time frame: 24 hours

  3. Ultimate Disposition

    Time frame: Longitudinal Follow-Up (approximately 3 months)

    Hospital death

  4. Total Bilirubin (mg/dL)

    Time frame: 24 hours

    participant laboratory value

  5. ALT (U/L)

    Time frame: 24 hours

    participant laboratory value

  6. AST (U/L)

    Time frame: 24 hours

    participant laboratory value

  7. Creatine Clearance/GFR

    Time frame: 24 hours

  8. Creatine (mg/dL)

    Time frame: 24 hours

    participant laboratory value

  9. Lactate millimoles per liter (mmol/L)

    Time frame: 24 hours

    participant laboratory value

  10. Pulmonary Artery Compliance (mmHg)

    Time frame: 24 hours

  11. Right Ventricular Stroke Work Index (g·m-²·beat-¹)

    Time frame: 24 hours

  12. Pulmonary Artery Pulsatility Index (PAPi)

    Time frame: 24 hours

    calculated measurement

  13. Pulmonary Vascular Resistance (dynes/cm⁵)

    Time frame: 24 hours

  14. Systemic Vascular Resistance (mmHg/L/min)

    Time frame: 24 hours

  15. Pulmonary Capillary Wedge Pressure (mmHg)

    Time frame: 24 hours

  16. Diastolic Pulmonary Arterial Pressure (mmHg)

    Time frame: 24 hours

  17. Systolic Pulmonary Artery Pressure (mmHg)

    Time frame: 24 hours

  18. Right Atrium Pressure (mmHg)

    Time frame: 24 hours

    report measurement

  19. Aortic Pulsatility Index (API)

    Time frame: 24 hours

    calculated measurement

  20. Cardiac Power Input (W/m²)

    Time frame: 24 hours

  21. Cardiac Power Output (Watts)

    Time frame: 24 hours

  22. Stroke Volume (mL)

    Time frame: 24 hours

  23. Cardiac Index (L/min/m²)

    Time frame: 24 hours

  24. Heart Rhythm

    Time frame: 24 hours

    Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other

  25. Heart Rate (beats per minute)

    Time frame: 24 hours

  26. Mean Arterial Pressure (mmHg)

    Time frame: 24 hours

  27. Diastolic Blood Pressure (mmHg)

    Time frame: 24 hours

  28. Systolic Blood Pressure (mmHg)

    Time frame: 24 hours

  29. Pulmonary Artery Compliance (mmHg)

    Time frame: 3-6 hours

  30. Right Ventricular Stroke Work Index (g·m-²·beat-¹)

    Time frame: 3-6 hours

  31. Pulmonary Artery Pulsatility Index (PAPi)

    Time frame: 3-6 hours

    calculated measurement

  32. Pulmonary Vascular Resistance (dynes/cm⁵)

    Time frame: 3-6 hours

  33. Systemic Vascular Resistance (mmHg/L/min)

    Time frame: 3-6 hours

  34. Pulmonary Capillary Wedge Pressure (mmHg)

    Time frame: 3-6 hours

  35. Diastolic Pulmonary Arterial Pressure (mmHg)

    Time frame: 3-6 hours

  36. Systolic Pulmonary Artery Pressure (mmHg)

    Time frame: 3-6 hours

  37. Right Atrium Pressure (mmHg)

    Time frame: 3-6 hours

    report measurement

  38. Aortic Pulsatility Index (API)

    Time frame: 3-6 hours

    calculated measurement

  39. Cardiac Power Input (W/m²)

    Time frame: 3-6 hours

  40. Cardiac Power Output (Watts)

    Time frame: 3-6 hours

  41. Stroke Volume (mL)

    Time frame: 3-6 hours

  42. Cardiac Index (L/min/m²)

    Time frame: 3-6 hours

  43. Cardiac Output (L/min)

    Time frame: 3-6 hours

  44. Pulmonary Artery Oxygen Saturation (%)

    Time frame: 3-6 hours

  45. Heart Rhythm

    Time frame: 3-6 hours

    Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other

  46. Heart Rate (beats per minute)

    Time frame: 3-6 hours

  47. Mean Arterial Pressure (mmHg)

    Time frame: 3-6 hours

  48. Diastolic Blood Pressure (mmHg)

    Time frame: 3-6 hours

  49. Systolic Blood Pressure (mmHg)

    Time frame: 3-6 hours

  50. Pulmonary Artery Compliance (mmHg)

    Time frame: 30 minutes

  51. Right Ventricular Stroke Work Index (g·m-²·beat-¹)

    Time frame: 30 minutes

  52. Pulmonary Artery Pulsatility Index (PAPi)

    Time frame: 30 minutes

    calculated measurement

  53. Pulmonary Vascular Resistance (dynes/cm⁵)

    Time frame: 30 minutes

  54. Systemic Vascular Resistance (mmHg/L/min)

    Time frame: 30 minutes

  55. Pulmonary Capillary Wedge Pressure (mmHg)

    Time frame: 30 minutes

  56. Diastolic Pulmonary Arterial Pressure (mmHg)

    Time frame: 30 minutes

  57. Systolic Pulmonary Artery Pressure (mmHg)

    Time frame: 30 minutes

  58. Right Atrium Pressure (mmHg)

    Time frame: 30 minutes

    report measurement

  59. Aortic Pulsatility Index (API)

    Time frame: 30 minutes

    calculated measurement

  60. Cardiac Power Input (W/m²)

    Time frame: 30 minutes

  61. Stroke Volume (mL)

    Time frame: 30 minutes

  62. Cardiac Power Output (Watts)

    Time frame: 30 minutes

  63. Cardiac Index (L/min/m²)

    Time frame: 30 minutes

  64. Cardiac Output (L/min)

    Time frame: 30 minutes

  65. Pulmonary Artery Oxygen Saturation (%)

    Time frame: 30 minutes

  66. Heart Rhythm

    Time frame: 30 minutes

    Normal Sinus Rhythm, Atrial Fibrillation, Atrial Flutter, Ventricular Fibrillation, Ventricular Tachycardia, Sinus Bradycardia, Sinus Tachycardia, other

  67. Heart Rate (beats per minute)

    Time frame: 30 minutes

  68. Mean Arterial Pressure (mmHg)

    Time frame: 30 minutes

  69. Diastolic Blood Pressure (mmHg)

    Time frame: 30 minutes

  70. Ultimate Disposition

    Time frame: Longitudinal Follow-Up (approximately 3 months)

    Heart recovery with discharge (alive)

  71. Ultimate Disposition

    Time frame: Longitudinal Follow-Up (approximately 3 months)

    Left Ventricular Assist Device (LVAD)

  72. Ultimate Disposition

    Time frame: Longitudinal Follow-Up (approximately 3 months)

    Transplant

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth R Westburg, MS

CONTACT

[email protected]

215-955-2050

Matthew S Delfiner, DO, MS

CONTACT

215-955-2050

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

Arterial Compliance as a Predictor of Clinical Outcomes With Intra-aortic Balloon Counterpulsation: A Prospective Observational Pilot Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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