AzTrials
AzTrials

Heart Failure With Reduced Ejection FractionPACE-SHOCKNCT06078436

Pulmonary Artery Catheterization and Carvedilol Early Initiation in Cardiogenic SHOCK Due to HFrEF

A study testing Pulmonary artery catheter in people with Heart Failure With Reduced Ejection Fraction and Cardiogenic Shock, run by Min-Seok Kim at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to compare the impact of hemodynamic monitoring using pulmonary artery catheter (PAC) on survival and inotropic agent reduction in patients with cardiogenic shock caused by heart failure with reduced ejection fraction (HFrEF). Read more about this study

Who is it for?
Ages 19 years and older
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
160 participants
Where
1 siteSouth Korea
Study dates
Jan 2024to Mar 2028
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults age 19 and above ( no age limit for elderly )
  • Patients with cardiogenic shock requiring intensive care monitoring in ICU
  • Patients eligible for oral medication administration
  • Patients who have provided research participation consent through a written informed consent form

Who cannot join

  • Unwilling or unable to obtain informed consent by the participant or substitute decision maker
  • Patients with mechanical circulatory support at the time of screening
  • Patients with acute coronary syndrome
  • Patients with severe valvular heart disease requiring emergent percutaneous procedures or surgery
  • Known hypersensitivity to beta-blockers
  • Patients with a history of bronchospasm or asthma
Show all 11Show fewer
  • Patients with bradycardia or second or third-degree atrioventricular block
  • Patients with sick sinus syndrome, including sinoatrial block
  • Patients with untreated pheochromocytoma
  • Patients currently undergoing de-sensitization therapy
  • Patients who are currently pregnant, postpartum period within 30 days or breast-feeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Min-Seok Kim, PhD contact

82-2-3010-3948

msk@amc.seoul.kr

South Korea1 site, 1 recruiting
  • Asan Medical Center

    Seoul, 05505

    Min Seok Kim, PhD, 02-3010-3948, msk@amc.seoul.kr

    Ah-Ram Kim, MD, 02-3010-0111, ahram3256@amc.seoul.kr

    Recruiting

Other trials in South Korea

About this study

Official title: Pulmonary Artery Catheterization and Carvedilol Early Initiation in Cardiogenic SHOCK Caused by Heart Failure With Reduced Ejection Fraction

This study aims to compare the impact of hemodynamic monitoring using pulmonary artery catheter (PAC) on survival and inotropic agent reduction in patients with cardiogenic shock caused by heart failure with reduced ejection fraction (HFrEF). The investigators also intend to compare the difference in long-term survival rates among patients who have recovered from cardiogenic shock due to HFrEF, based on the timing of initiation of beta-blocker treatment.

Read the detailed description

Cardiogenic shock is one of the most common causes of shock patients admitted to the Cardiac Intensive Care Unit (CICU). Despite advances in treatment, the mortality rate of cardiogenic shock remains high, up to 50%, and improving survival is crucial through the use of inotropic agents, vasopressors, or mechanical circulatory support devices to improve hemodynamic parameters. Previous meta-analyses of retrospective studies have shown the usefulness of pulmonary artery catheter monitoring, especially in patients with cardiogenic shock due to heart failure. However, there is a lack of prospective studies regarding specific monitoring indicators and treatment goals. This study aims to compare the impact of hemodynamic monitoring through pulmonary artery catheter on survival and inotropic agent reduction in patients with cardiogenic shock caused by heart failure with reduced ejection fraction.

In the PAC non-monitoring group, various assessments such as physical examination, echocardiographic findings, serum lactate levels, chest x-ray, and laboratory test results are utilized. If there are signs of volume overload, diuretics or hemodialysis may be applied to achieve for volume reduction. The dosage of diuretics and the timing of hemodialysis are at the discretion of the attending physician. The target of a mean arterial pressure (MAP) is 65mmHg or higher. If the MAP falls below 65mmHg, increasing vasopressor or inotropes should be considered. If the MAP target is not achieved with medical therapy or if serum lactate levels increase by 3 mmol/L or more compared to the lowest value within 24 hours, mechanical circulatory support (MCS) is considered. The specific dosage of vasopressors/inotropes and the timing of MCS application are at the dscretion of the attending physician.

The PAC monitoring group, in addition to those used in the PAC non-monitoring group, treats patients using indicators measured by PAC. The targets include a right atrial pressure (RAP) or central venous pressure (CVP) of 8mmHg or lower and pulmonary capillary wedge pressure (PCWP) of 15mmHg or lower. Whan RAP or CVP exceeds 8mmHg, or PCWP exceeds 15mmHg, employing diuretics or hemodialysis should be considered for volume reduction. The dosage of diuretics and the timing of hemodialysis are at the discretion of the attending physician. The target of a mean arterial pressure (MAP) is 65mmHg or higher. If the MAP falls below 65mmHg, increasing vasopressor or inotropes should be considered. If the MAP target is not achieved with medical therapy or if serum lactate levels increase by 3 mmol/L or more compared to the lowest value within 24 hours, mechanical circulatory support (MCS) is considered. The specific dosage of vasopressors/inotropes and the timing of MCS application are at the dscretion of the attending physician.

Additionally, the beta-blocker Carvedilol is known to reduce mortality and readmission rates in heart failure patients based on large-scale clinical trials and is widely prescribed as a standard treatment. However, the evidence for the appropriate timing of Carvedilol initiation and objective indicators of hemodynamic stability beyond the point of discharge is currently insufficient, relying solely on the clinical judgment and experience of the treating physician. Through subgroup analysis, the investigators intend to compare the difference in long-term survival rates among patients who have recovered from cardiogenic shock due to heart failure with reduced ejection fraction, based on the timing of iniation of beta-blocker treatment. The early administration of Carvedilol is defined as initiating treatment within 24 to 48 hours after discontinuing vasopressor/inotropic agents or mechanical circulatory support in stable condition following cardiogenic shock. The conservative administration of Carvedilol is defined as initiating treatment at least 48 hours after discontinuing vasopressors/inotropic agents or mechanical circulatory support in stable condition following cardiogenic shock.

Also, lung B-line will be measure along with PAC measured hemodynamic parameters using lung ultrasound at eight regions of the thorax in patients with PAC monitoring. Number of B-line in a total and each region, positive region which is defined as having three or more number of B-line will be recorded. Acquired images will be adjudicated by two investigators who are blinded to the clinical information of the subject.

Being tested
Pulmonary artery catheter
Keywords
Cardiogenic shock, Heart failure with reduced ejection fraction (HFrEF), Hemodynamic monitoring, Pulmonary artery catheter, Carvedilol
Medical subject headings
Shock, Cardiogenic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary artery catheterDevice

    Also called Swan-Ganz catheter

    Pulmonary artery catheter monitoring or not

Study groups in NCT06078436
Study groupRoleWhat they receive
Pulmonary artery catheter monitoring groupExperimentalWithin 8 hours of random allocation, a pulmonary artery catheter will be inserted to monitor hemodynamic parameters.
Receives: Device: Pulmonary artery catheter
No pulmonary artery catheter monitoring groupActive comparatorAfter random allocation, a pulmonary artery catheter will not be inserted during cardiogenic shock management.
Receives: Device: Pulmonary artery catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day all-cause mortality

    All-cause mortality

    Measured: From date of randomization until the date of death from any cause, assessed up to 30 days

Secondary outcomes (9)
  1. All-cause mortality

    All-cause of death

    Measured: From date of randomization until the date of death from any cause, assessed up to 3 months

  2. Cardiovascular mortality

    Cardiovascular death

    Measured: From date of randomization until the date of death from any cause, assessed up to 3 months

  3. Timing of discontinuation of inotropic or vasopressor agents

    Days from randomization to discontinuation of inotropes/vasopressor

    Measured: From date of randomization until the date of discharge or assessed up to 90 days

  4. The rate of Carvedilol intake on the 3 months

    The rate of Carvedilol intake

    Measured: 3 months from date of randomization

  5. The target-dose achievement rate of Carvedilol on the 3 months

    Target dose : 50mg/day

    Measured: 3 months from date of randomization

  6. 3-month follow-up echocardiography parameters

    LVEF(left ventricular ejection fraction)

    Measured: 3 months from date of randomization

  7. Complications related with pulmonary artery catheter

    Any complications related with pulmonary artery catheter

    Measured: During hospitalization period, up to 30 days

  8. Hospitalization due to heart failure

    Unplanned hospitalization due to heart failure

    Measured: 3 months from date of randomization

  9. The composite outcome of cardoivascular death and heart failure hospitalization

    The composite outcome of cardiovascular death and hospitalization due to heart failure

    Measured: 3 months from date of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2023
  2. Study startJan 2024 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

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
Model description
From the time of diagnosing cardiogenic shock (CS) caused by HFrEF within 12 hours, random allocation will be conducted. If assigned to the hemodynamic monitoring group with pulmonary artery catheter (PAC), the catheter will be inserted and hemodynamic parameters will be monitored until recovery from CS. The non-monitoring group will receive CS treatment without inserting a PAC.
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06078436
Sponsor's protocol ID
AMC_2023_0794
Acronym
PACE-SHOCK
Status last verified
Jan 2024
First submitted
20 Sep 2023
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pulmonary artery catheter in people with Heart Failure With Reduced Ejection Fraction and Cardiogenic Shock, run by Min-Seok Kim at 1 site in South Korea.

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 11 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 5 Jan 2024. 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 South Korea. 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 Min-Seok Kim, PhD (82-2-3010-3948, msk@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day all-cause mortality (time frame: From date of randomization until the date of death from any cause, assessed up to 30 days). 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 5 Jan 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in