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

NCT06078436 | Recruiting DMC

• 1 other identifier: AMC_2023_0794
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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). 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.

Conditions

Heart Failure With Reduced Ejection Fraction; Cardiogenic Shock

Keywords

Cardiogenic shock; Heart failure with reduced ejection fraction (HFrEF); Hemodynamic monitoring; Pulmonary artery catheter; Carvedilol

Outcome Measures

Primary Outcomes (1)

• 30-day all-cause mortality

  All-cause mortality

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

Secondary Outcomes (9)

• All-cause mortality

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

• Cardiovascular mortality

  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

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

• The rate of Carvedilol intake on the 3 months

  3 months from date of randomization

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

  3 months from date of randomization

Study Arms (2)

Pulmonary artery catheter monitoring group

EXPERIMENTAL

Within 8 hours of random allocation, a pulmonary artery catheter will be inserted to monitor hemodynamic parameters.

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.

Device: Pulmonary artery catheter

Interventions

Pulmonary artery catheter DEVICE

Pulmonary artery catheter monitoring or not

Also known as: Swan-Ganz catheter

No pulmonary artery catheter monitoring group; Pulmonary artery catheter monitoring group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Min-Seok Kim: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Min-Seok Kim

  Asan Medical Center

  STUDY CHAIR

Central Study Contacts

Min-Seok Kim, PhD

CONTACT

82-2-3010-3948; msk@amc.seoul.kr

Ah-Ram Kim, MD

CONTACT

82-2-3010-0111; ahram3256@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 11, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)