Vasopressors, Inotropes, and Support Devices for Cardiogenic Shock
(CSWG Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how different treatments work for individuals with cardiogenic shock, a serious heart condition where the heart suddenly fails to pump enough blood to meet the body's needs. Researchers collect information on treatments such as acute mechanical circulatory support devices, inotropes (medications that strengthen heart contractions), and vasopressors (medications that constrict blood vessels to raise blood pressure) to assess their impact on recovery. The trial suits those who have experienced cardiogenic shock, particularly if they required special heart support devices or medications during a hospital stay. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown mixed safety results for treatments in cardiogenic shock. Let's simplify it:
1. **Acute Mechanical Circulatory Support Devices**: These devices assist the heart but may cause complications. Limited safety information exists, yet their common use suggests some utility. Discuss potential risks with your doctor.
2. **Inotropes**: These drugs enhance heart pumping. However, some studies suggest they might increase death risk for certain patients. Their varied use across hospitals indicates safety uncertainty, necessitating careful application.
3. **Vasopressors**: These drugs raise blood pressure and are frequently used, though little is known about their effects in cardiogenic shock. Some research suggests they might be safer when combined with other treatments, but their safety remains uncertain.
In summary, each treatment carries specific risks and benefits. Consider these carefully and discuss them with your healthcare provider.12345Why are researchers excited about this trial?
Researchers are excited about the use of acute mechanical circulatory support devices, inotropes, and vasopressors for cardiogenic shock because these treatments offer innovative ways to stabilize patients quickly. Unlike traditional treatments that might rely solely on medications like beta-blockers or ACE inhibitors, these options provide direct mechanical and pharmacological support to the heart. Mechanical circulatory support devices can take over the work of the heart, giving it a chance to recover, while inotropes and vasopressors are designed to improve heart muscle contraction and blood pressure. This multifaceted approach aims to provide rapid stabilization, which is crucial for improving outcomes in cardiogenic shock patients.
What evidence suggests that this trial's treatments could be effective for cardiogenic shock?
This trial will evaluate different treatments for patients with cardiogenic shock. Research has shown that Acute Mechanical Circulatory Support Devices can help some patients with heart failure, but results vary. For instance, one study found these devices did not improve survival rates after 30 days for patients in shock. However, another study suggested that using certain devices like Impella might lead to better outcomes compared to ECMO (a type of life support) when no other treatments are used.
Medications called inotropes, which help the heart pump better, have shown mixed results. Some studies suggest they can improve survival in intensive care, while others indicate a higher risk of death within 30 days for patients taking these drugs.
For vasopressors, which tighten blood vessels and increase blood pressure, more research is needed to understand their role in treating heart failure. Overall, treatment effectiveness can vary based on each patient's condition and the specific treatments used. Participants in this trial may receive one or more of these treatments as part of their care.36789Who Is on the Research Team?
Claudius Mahr, DO
Principal Investigator
University of Washington
Jaime Hernandez-Montfort, MD
Principal Investigator
Cleveland Clinic Foundation-Florida
Daniel Burkhoff, MD PhD
Principal Investigator
CardioVascular Research Foundation
Reshad Garan, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Retrospective Data Collection
Data is collected during the course of the hospital stay from medical records
Prospective Follow-up
Long-term outcomes are assessed through follow-up phone calls
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Acute Mechanical Circulatory Support Devices
- Inotrope
- Vasopressor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tufts Medical Center
Lead Sponsor
Getinge Inc.
Collaborator
Boston Scientific Corporation
Industry Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology
Abiomed Inc.
Industry Sponsor
Getinge Group
Collaborator
Abbott
Industry Sponsor
Dr. Etahn Korngold
Abbott
Chief Medical Officer
MD, Harvard Medical School
Robert B. Ford
Abbott
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business