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

Study Overview
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Brief Summary
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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). Also, the investigators intend to investigate the difference in long-term survival rates in patients who have recovered from cardiogenic shock due to HFrEF and received early beta-blocker treatment based on PAC monitoring.

Detailed Description
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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. 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. Therefore, 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. Additionally, the investigators intend to investigate the difference in long-term survival rates in patients who have recovered from cardiogenic shock due to heart failure with reduced ejection fraction and received early beta-blocker treatment based on pulmonary artery catheter monitoring. 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.

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

Conditions
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Heart Failure With Reduced Ejection Fraction, Cardiogenic Shock

Intervention / Treatment
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* Device: Pulmonary artery catheter
* Drug: Carvedilol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Unwilling or unable to obtain informed consent by the participant or substitute decision maker 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 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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. Additionally, within each group, subgroups will be randomly assigned to either early Carvedilol administration or conservative administration. The early administration subgroup will start Carvedilol within 24 to 48 hours after discontinuing vasopressors/inotropic agents or mechanical circulatory support in stable condition following CS. The conservative administration subgroup will begin Carvedilol administration at least 48 hours after discontinuing vasopressors/inotropic agents or mechanical circulatory support in stable condition following CS.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary artery catheter monitoring group with early Carvedilol administration<br>Within 8 hours of random allocation, a pulmonary artery catheter will be inserted to monitor hemodynamic parameters. Additionally, starting from 24 to 48 hours after discontinuing vasopressors/inotropic agents or mechanical circulatory support (MCS) in stable condition following cardiogenic shock, Carvedilol administration will begin. | Device: Pulmonary artery catheter<br>* Pulmonary artery catheter monitoring or not<br>* Other names: Swan-Ganz catheter;Drug: Carvedilol<br>* Early Carvedilol initiation: administer Carvedilol from 24 to 48 hours after discontinuing vasopressors/inotropes or MCS Conservative Carvedilol initiation: administer Carvedilol 48 hours after discontinuing vasopressor/inotropes or MCS<br>* Other names: Dilatrend;|
| Experimental: Pulmonary artery catheter monitoring group with conservative Carvedilol administration<br>Within 8 hours of random allocation, a pulmonary artery catheter will be inserted to monitor hemodynamic parameters. Additionally, starting from 48 hours after discontinuing vasopressors/inotropic agents or MCS in stable condition following cardiogenic shock, the administration of Carvedilol will be initiated based on the clinical judgment of the physician. | Device: Pulmonary artery catheter<br>* Pulmonary artery catheter monitoring or not<br>* Other names: Swan-Ganz catheter;Drug: Carvedilol<br>* Early Carvedilol initiation: administer Carvedilol from 24 to 48 hours after discontinuing vasopressors/inotropes or MCS Conservative Carvedilol initiation: administer Carvedilol 48 hours after discontinuing vasopressor/inotropes or MCS<br>* Other names: Dilatrend;|
| Active Comparator: No pulmonary artery catheter monitoring group with early Carvedilol administration<br>After random allocation, a pulmonary artery catheter will not be inserted during cardiogenic shock management. Additionally, starting from 24 to 48 hours after discontinuing vasopressors/inotropic agents or MCS in stable condition following cardiogenic shock, Carvedilol administration will begin. | Drug: Carvedilol<br>* Early Carvedilol initiation: administer Carvedilol from 24 to 48 hours after discontinuing vasopressors/inotropes or MCS Conservative Carvedilol initiation: administer Carvedilol 48 hours after discontinuing vasopressor/inotropes or MCS<br>* Other names: Dilatrend;|
| Active Comparator: No pulmonary artery catheter monitoring group with conservative Carvedilol administration<br>After random allocation, a pulmonary artery catheter will not be inserted during cardiogenic shock management. Additionally, starting from 48 hours after discontinuing vasopressors/inotropic agents or MCS in stable condition following cardiogenic shock, the administration of Carvedilol will be initiated based on the clinical judgment of the physician. | Drug: Carvedilol<br>* Early Carvedilol initiation: administer Carvedilol from 24 to 48 hours after discontinuing vasopressors/inotropes or MCS Conservative Carvedilol initiation: administer Carvedilol 48 hours after discontinuing vasopressor/inotropes or MCS<br>* Other names: Dilatrend;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-day all-cause mortality | All-cause mortality | From date of randomization until the date of death from any cause, assessed up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | All-cause of death | From date of randomization until the date of death from any cause, assessed up to 6 months | 
| Cardiovascular mortality | Cardiovascular death | From date of randomization until the date of death from any cause, assessed up to 6 months | 
| Timing of discontinuation of inotropic or vasopressor agents | Days from randomization to discontinuation of inotropes/vasopressor | 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 | 3 months from date of randomization | 
| The target-dose achievement rate of Carvedilol on the 3 months | Target dose : 50mg/day | 3 months from date of randomization | 
| 6-month follow-up echocardiography parameters | LVEF(left ventricular ejection fraction) | 6 months from date of randomization | 
| Complications related with pulmonary artery catheter | Any complications related with pulmonary artery catheter | During hospitalization period, up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiogenic shock, Heart failure with reduced ejection fraction (HFrEF), Hemodynamic monitoring, Pulmonary artery catheter, Carvedilol