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.
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
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Cardiogenic Shock
- 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.
South Korea1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Pulmonary artery catheter monitoring group | Experimental | Within 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 group | Active comparator | After 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.
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)
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
Cardiovascular mortality
Cardiovascular death
Measured: From date of randomization until the date of death from any cause, assessed up to 3 months
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
The rate of Carvedilol intake on the 3 months
The rate of Carvedilol intake
Measured: 3 months from date of randomization
The target-dose achievement rate of Carvedilol on the 3 months
Target dose : 50mg/day
Measured: 3 months from date of randomization
3-month follow-up echocardiography parameters
LVEF(left ventricular ejection fraction)
Measured: 3 months from date of randomization
Complications related with pulmonary artery catheter
Any complications related with pulmonary artery catheter
Measured: During hospitalization period, up to 30 days
Hospitalization due to heart failure
Unplanned hospitalization due to heart failure
Measured: 3 months from date of randomization
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.
- First posted11 Oct 2023
- Study startJan 2024 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Min-Seok Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Min-Seok Kim, Asan Medical Center
- Investigators
- Min-Seok Kim, Study chair, Asan Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Artery Catheterization and Carvedilol Early Initiation in Cardiogenic SHOCK Caused by Heart Failure With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT06078436
- Acronym / sponsor ID
- PACE-SHOCK / AMC_2023_0794
- Keywords
- Cardiogenic shock, Heart failure with reduced ejection fraction (HFrEF), Hemodynamic monitoring, Pulmonary artery catheter, Carvedilol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Min-Seok KimUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 11 Oct 2023 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pulmonary artery catheter monitoring group | Experimental | Device: Pulmonary artery catheterWithin 8 hours of random allocation, a pulmonary artery catheter will be inserted to monitor hemodynamic parameters. |
| No pulmonary artery catheter monitoring group | Active comparator | Device: Pulmonary artery catheterAfter random allocation, a pulmonary artery catheter will not be inserted during cardiogenic shock management. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 catheterAlso: Swan-Ganz catheterPulmonary artery catheter monitoring or not | Device | No pulmonary artery catheter monitoring group, Pulmonary artery catheter monitoring group |
Primary outcome
30-day all-cause mortality
Time frame: From date of randomization until the date of death from any cause, assessed up to 30 days
All-cause mortality
9 secondary outcomes
All-cause mortality
Time frame: From date of randomization until the date of death from any cause, assessed up to 3 months
Cardiovascular mortality
Time frame: From date of randomization until the date of death from any cause, assessed up to 3 months
Timing of discontinuation of inotropic or vasopressor agents
Time frame: From date of randomization until the date of discharge or assessed up to 90 days
The rate of Carvedilol intake on the 3 months
Time frame: 3 months from date of randomization
The target-dose achievement rate of Carvedilol on the 3 months
Time frame: 3 months from date of randomization
3-month follow-up echocardiography parameters
Time frame: 3 months from date of randomization
Complications related with pulmonary artery catheter
Time frame: During hospitalization period, up to 30 days
Hospitalization due to heart failure
Time frame: 3 months from date of randomization
The composite outcome of cardoivascular death and heart failure hospitalization
Time frame: 3 months from date of randomization
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 5 Jan 2024.
- 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.
Min-Seok Kim study chair
Asan Medical Center
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 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; AzTrials last refreshed its copy on 8 Nov 2026.