Using a pulmonary artery catheter and early carvedilol treatment for cardiogenic shock in heart failure patients
Pulmonary Artery Catheterization and Carvedilol Early Initiation in Cardiogenic SHOCK Caused by Heart Failure With Reduced Ejection Fraction
NA · Asan Medical Center · NCT06078436
This study is testing if using a special heart monitor along with early treatment with carvedilol can help heart failure patients in cardiogenic shock live longer and need less medication.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Asan Medical Center (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06078436 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of hemodynamic monitoring using a pulmonary artery catheter on survival rates and the reduction of inotropic agents in patients experiencing cardiogenic shock due to heart failure with reduced ejection fraction (HFrEF). It will compare outcomes between patients receiving this monitoring and those who do not, focusing on long-term survival based on the timing of beta-blocker initiation. The study addresses a critical gap in prospective research regarding monitoring indicators and treatment goals in this high-mortality condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older who are experiencing cardiogenic shock and require intensive care monitoring.
Not a fit: Patients with mechanical circulatory support, acute coronary syndrome, or severe valvular heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates and reduce the need for inotropic agents in patients with cardiogenic shock.
How similar studies have performed: Previous meta-analyses have shown the usefulness of pulmonary artery catheter monitoring in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Min-Seok Kim, PhD
- Email: msk@amc.seoul.kr
- Phone: 82-2-3010-3948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure With Reduced Ejection Fraction, Cardiogenic Shock, Cardiogenic shock, Heart failure with reduced ejection fraction, Hemodynamic monitoring, Pulmonary artery catheter, Carvedilol