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

Sponsor

Min-Seok Kim (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06078436

Collaborator

(none)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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). 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Reduced Ejection Fraction Cardiogenic Shock	Device: Pulmonary artery catheter Drug: Carvedilol	N/A

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.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2027

Anticipated Study Completion Date :

Mar 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pulmonary artery catheter monitoring group with early Carvedilol administration 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 Pulmonary artery catheter monitoring or not Other Names: Swan-Ganz catheter Drug: Carvedilol 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 Other Names: Dilatrend
Experimental: Pulmonary artery catheter monitoring group with conservative Carvedilol administration 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 Pulmonary artery catheter monitoring or not Other Names: Swan-Ganz catheter Drug: Carvedilol 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 Other Names: Dilatrend
Active Comparator: No pulmonary artery catheter monitoring group with early Carvedilol administration 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 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 Other Names: Dilatrend
Active Comparator: No pulmonary artery catheter monitoring group with conservative Carvedilol administration 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 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 Other Names: Dilatrend

Outcome Measures

Primary Outcome Measures

90-day all-cause mortality [From date of randomization until the date of death from any cause, assessed up to 90 days]
All-cause mortality

Secondary Outcome Measures

All-cause mortality [From date of randomization until the date of death from any cause, assessed up to 6 months]
All-cause of death
Cardiovascular mortality [From date of randomization until the date of death from any cause, assessed up to 6 months]
Cardiovascular death
Timing of discontinuation of inotropic or vasopressor agents [From date of randomization until the date of discharge or assessed up to 90 days]
Days from randomization to discontinuation of inotropes/vasopressor
The rate of Carvedilol intake on the 3 months [3 months from date of randomization]
The rate of Carvedilol intake
The target-dose achievement rate of Carvedilol on the 3 months [3 months from date of randomization]
Target dose : 50mg/day
6-month follow-up echocardiography parameters [6 months from date of randomization]
LVEF(left ventricular ejection fraction)
Complications related with pulmonary artery catheter [During hospitalization period, up to 30 days]
Any complications related with pulmonary artery catheter

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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