Cardiogenic ShockPACCSNCT05485376
Pulmonary Artery Catheter in Cardiogenic Shock Trial
A study testing Pulmonary Artery Catheter in people with Cardiogenic Shock and Heart Failure, run by Tufts Medical Center at 1 site in United States.
Trial summary
The primary objective of the PACCS trial is to assess if early invasive hemodynamic assessment and ongoing management with a PAC in patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS) is associated with lower in-hospital mortality risk compared to the current standard of care with no… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiogenic Shock, Heart Failure
- What is being tested?
- Pulmonary Artery Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2022to 1 Sep 2026
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤90 years
- Clinical heart failure presentation and left ventricular function as follows: Either 2A or 2B must be present A. Subject has de novo acute decompensated heart failure and shock with an LVEF ≤40% OR B. Subject has acute on chronic heart failure with a documented history of a LVEF ≤40% within 6 months of admission and a current LVEF ≤40% within 24 hours of screening during the current hospitalization.
- NOTE: The LVEF must be quantitatively measured as ≤ 40% by an echocardiogram within 24 hours of screening. If multiple echocardiograms have been performed within 24 hours, the most recent test must be used to qualify the patient.
- Cardiogenic Shock (CS) defined by a lactate level ≥ 2.1 mmol/L and any 2 of the following parameters within 24 hours of screening:
- SBP <90 mmHg for more than 30 minutes from baseline SBP
- Requires the use of at least 1 vasopressor or inotrope
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- Requires intra-aortic balloon pump (IABP) support
- Presence of congestion on exam: JVP elevated, pulmonary edema on CXR or exam, dyspnea at rest, orthopnea, bendopnea, or worsening peripheral or abdominal swelling
- Initial diagnosis of CS within 24 hours of screening at the enrolling site
- Patient or legally authorized representative provides informed consent
- A HIPAA waiver for screening is requested to identify potential subjects. No recruitment materials will be given to potential subjects. No identifiable data will be retained for subjects that are determined to be ineligible
Who cannot join
- Primary etiology of shock other than systolic left heart failure including but not limited to: acute myocardial infarction, sepsis, hypovolemia, hemorrhage, severe anemia, primary RV failure, pulmonary embolism, or tamponade.
- Patient has a durable ventricular assist device or temporary mechanical circulatory support (other than IABP) or PAC prior to enrollment
- Actively listed for cardiac transplantation (Status 7 patients are eligible for the trial)
- Patient transferred from another facility with a diagnosis of cardiogenic shock
- Any known co-morbidity other than heart failure with anticipated survival < 6 months
- Pre-enrollment labs (any of the following): International Normalized Ratio (INR) > 3, Platelet count < 50k, Hemoglobin < 7
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- Refractory or recurrent cardiac arrest (>1 episode requiring defibrillation or cardiopulmonary resuscitation) within 24 hours prior to screening
- DNR/ DNI status
- Pregnancy, child-birth within 6 months, or lactation
- Active infection documented by persistent fever (Temp > 38.4oC within 24 hours of screening) or confirmed bacteremia
- Implantation of PPM or ICD within past 3 months
- Mechanical complication of AMI (ie VSD, papillary muscle rupture, flail mitral regurgitation, free wall rupture)
- Anoxic brain injury
- On renal replacement therapy prior to enrollment
- Cardiac surgery within 3 months of current admission
- Severe aortic, pulmonic, tricuspid stenosis or acute structural mitral regurgitation or infective endocarditis
- History of cardiac amyloid
- Congenital heart disease excluding the presence of a bicuspid aortic valve
- Planned cardiac surgery during admission
- World Health Organization (WHO) Group I, III, IV, or V pulmonary hypertension
- Any known contraindication to PAC placement
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint
- Any medical or psychiatric condition such as dementia, alcoholism, or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up
- Prior stroke with any permanent neurologic deficit or any prior intracranial hemorrhage or any prior subdural hematoma or known intracranial pathology pre-disposing to intracranial bleeding, such as an arteriovenous malformation or mass
- Subject has previously hospitalized for COVID-19 unless he/she has been discharged and asymptomatic for ≥4 weeks
- Subject is COVID-19 PCR/antigen positive within the prior 4 weeks
- Subject belongs to a vulnerable population [defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, members of the armed forces and persons kept in detention]
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vanessa Palomo contact
United States1 site, 1 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Karol Walec, 6176364907, kwalec@tuftsmedicalcenter.org
Vanessa Palomo, vpalomo@tuftsmedicalcenter.org
About this study
Official title: The Pulmonary Artery Catheter in Cardiogenic Shock Trial
The primary objective of the PACCS trial is to assess if early invasive hemodynamic assessment and ongoing management with a PAC in patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS) is associated with lower in-hospital mortality risk compared to the current standard of care with no or delayed PAC assessment.
Read the detailed description
The PACCS trial is a multicenter, randomized, parallel group, adaptive trial that will test the hypothesis that early invasive hemodynamic assessment (within 6 hours of randomization) and ongoing management with a PAC decreases in-hospital mortality compared to clinical management with delayed (beyond 48 hours after randomization) or no PAC-guided assessment among patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS). The trial uses an adaptive sample size re-estimation design. An interim analysis will be performed when the primary endpoint is available for 200 participants and may lead to an increase in the target sample size (minimum sample size 400, maximum sample size 800).
- Conditions
- Cardiogenic Shock, Heart Failure
- Being tested
- Pulmonary Artery Catheter
- Keywords
- Pulmonary Artery Catheter
- Medical subject headings
- Shock, Cardiogenic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Artery CatheterDevice
The pulmonary artery catheter (PAC) is a diagnostic instrument that enables continuous hemodynamic monitoring of cardiac filling pressures, cardiac output, and pulmonary pressures.
| Study group | Role | What they receive |
|---|---|---|
| Early Pulmonary Artery Catheter | Experimental | If you are in the experimental group a PAC will be placed within 6 hours of randomization and within 24 hours of presentation with ADHF-CS. Receives: Device: Pulmonary Artery Catheter |
| No or delayed Pulmonary Artery Catheter | No intervention | If you are in the control group, a PAC will not be placed during hospitalization or may be placed 48 hours after randomization into the study. Placement of a PAC within 48 hours is only permitted for emergencies. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who die in the hospital
Measured: Length of stay in hospital, an average of 30 days
Secondary outcomes (8)
Number of Participants with in-hospital Cardiac Arrest
Measured: Length of stay in hospital, an average of 30 days
Number of Participants that require Mechanical Ventilation
Measured: Length of stay in hospital, an average of 30 days
Number of Participants that require Renal Replacement Therapy
Measured: Within 96 hours of randomization
Length of stay in CCU or ICU
Measured: Length of stay in hospital, an average of 30 days
Occurrence of heart transplantation and durable LVAD implantation
Measured: Length of stay in hospital, an average of 30 days
Death
Measured: 30 days and 6 months after discharge
Heart failure hospitalizations/emergency room visits
Measured: 30 days and 6 months after discharge
Admission to an outpatient IV diuretic center
Measured: 30 days and 6 months after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start23 Aug 2022
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Navin K Kapur, MD, Principal investigator, nkapur@tuftsmedicalcenter.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485376
- Sponsor's protocol ID
- 00002564
- Acronym
- PACCS
- Status last verified
- Oct 2025
- First submitted
- 17 Jun 2022
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Filipescu R, Collins SP, Radu RI, Ben Gal T, Antohi L, Abdelhamid M, Geavlete O, Pana M, Farmakis D, Matei DC, Savarese G, Margineanu C, Polovina M, Miro O, Guz D, Palazzuoli A, Masip J, Adamo M, Ambrosy AP, Chioncel O. Therapeutic Advances in the Management of Cardiogenic Shock. Am J Ther. 2026 Mar-Apr 01;33(2):e132-e145. doi: 10.1097/MJT.0000000000002025. Epub 2026 Jan 15.
PubMed 41543923
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pulmonary Artery Catheter in Cardiogenic Shock Trial
- ClinicalTrials.gov ID
- NCT05485376
- Acronym / sponsor ID
- PACCS / 00002564
- Conditions
- Cardiogenic Shock, Heart Failure
- Keywords
- Pulmonary Artery Catheter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 3 Aug 2022 (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 primary objective of the PACCS trial is to assess if early invasive hemodynamic assessment and ongoing management with a PAC in patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS) is associated with lower in-hospital mortality risk compared to the current standard of care with no or delayed PAC assessment.
Detailed description
The PACCS trial is a multicenter, randomized, parallel group, adaptive trial that will test the hypothesis that early invasive hemodynamic assessment (within 6 hours of randomization) and ongoing management with a PAC decreases in-hospital mortality compared to clinical management with delayed (beyond 48 hours after randomization) or no PAC-guided assessment among patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS). The trial uses an adaptive sample size re-estimation design. An interim analysis will be performed when the primary endpoint is available for 200 participants and may lead to an increase in the target sample size (minimum sample size 400, maximum sample size 800).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Pulmonary Artery Catheter | Experimental | Device: Pulmonary Artery CatheterIf you are in the experimental group a PAC will be placed within 6 hours of randomization and within 24 hours of presentation with ADHF-CS. |
| No or delayed Pulmonary Artery Catheter | No intervention | –If you are in the control group, a PAC will not be placed during hospitalization or may be placed 48 hours after randomization into the study. Placement of a PAC within 48 hours is only permitted for emergencies. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years and ≤90 years
- Clinical heart failure presentation and left ventricular function as follows: Either 2A or 2B must be present A. Subject has de novo acute decompensated heart failure and shock with an LVEF ≤40% OR B. Subject has acute on chronic heart failure with a documented history of a LVEF ≤40% within 6 months of admission and a current LVEF ≤40% within 24 hours of screening during the current hospitalization.
- NOTE: The LVEF must be quantitatively measured as ≤ 40% by an echocardiogram within 24 hours of screening. If multiple echocardiograms have been performed within 24 hours, the most recent test must be used to qualify the patient.
- Cardiogenic Shock (CS) defined by a lactate level ≥ 2.1 mmol/L and any 2 of the following parameters within 24 hours of screening:
- Initial diagnosis of CS within 24 hours of screening at the enrolling site
Key exclusion criteria (27 listed)
- Primary etiology of shock other than systolic left heart failure including but not limited to: acute myocardial infarction, sepsis, hypovolemia, hemorrhage, severe anemia, primary RV failure, pulmonary embolism, or tamponade.
- Patient has a durable ventricular assist device or temporary mechanical circulatory support (other than IABP) or PAC prior to enrollment
- Actively listed for cardiac transplantation (Status 7 patients are eligible for the trial)
- Patient transferred from another facility with a diagnosis of cardiogenic shock
- Any known co-morbidity other than heart failure with anticipated survival < 6 months
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 |
|---|---|---|
| Pulmonary Artery CatheterThe pulmonary artery catheter (PAC) is a diagnostic instrument that enables continuous hemodynamic monitoring of cardiac filling pressures, cardiac output, and pulmonary pressures. | Device | Early Pulmonary Artery Catheter |
Primary outcome
Number of participants who die in the hospital
Time frame: Length of stay in hospital, an average of 30 days
8 secondary outcomes
Number of Participants with in-hospital Cardiac Arrest
Time frame: Length of stay in hospital, an average of 30 days
Number of Participants that require Mechanical Ventilation
Time frame: Length of stay in hospital, an average of 30 days
Number of Participants that require Renal Replacement Therapy
Time frame: Within 96 hours of randomization
Length of stay in CCU or ICU
Time frame: Length of stay in hospital, an average of 30 days
Occurrence of heart transplantation and durable LVAD implantation
Time frame: Length of stay in hospital, an average of 30 days
Death
Time frame: 30 days and 6 months after discharge
Heart failure hospitalizations/emergency room visits
Time frame: 30 days and 6 months after discharge
Admission to an outpatient IV diuretic center
Time frame: 30 days and 6 months after discharge.
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 29 Oct 2025.
- Derived from this study: PubMed 41543923Filipescu R, Collins SP, Radu RI, Ben Gal T, Antohi L, Abdelhamid M, Geavlete O, Pana M, Farmakis D, Matei DC, Savarese G, Margineanu C, Polovina M, Miro O, Guz D, Palazzuoli A, Masip J, Adamo M, Ambrosy AP, Chioncel O. Therapeutic Advances in the Management of Cardiogenic Shock. Am J Ther. 2026 Mar-Apr 01;33(2):e132-e145. doi: 10.1097/MJT.0000000000002025. Epub 2026 Jan 15.
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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.
Vanessa Palomo contact
Navin K Kapur, MD principal investigator
nkapur@tuftsmedicalcenter.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Artery Catheter in people with Cardiogenic Shock and Heart Failure, run by Tufts Medical Center 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 11 inclusion and 27 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 29 Oct 2025. 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 Karol Walec (617-636-4907, kwalec@tuftsmedicalcenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who die in the hospital (time frame: Length of stay in hospital, an average of 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05485376, which also lists 1 linked publication.
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 29 Oct 2025.