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Shock, Cardiogenic clinical trials

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NCT ID: NCT06127927 Recruiting - Cardiogenic Shock Clinical Trials

Evaluation the Efficacy and Safety of an Interventional Left Ventricular Assist System for Hemodynamic Support in Patients With Cardiogenic Shock

Start date: November 8, 2023
Phase: N/A
Study type: Interventional

Imported Impella The price is relatively expensive and difficult for ordinary patients to afford. In order to better meet the growing clinical needs in China, Anhui Tongling Bionic Technology Co., Ltd. has developed an interventional left ventricular assist system. The test device was tested in preclinical animals It has shown good effectiveness and safety. Through the implementation of this clinical trial, the interventional left ventricular assist system The safety and effectiveness of the system for hemodynamic support in patients with cardiogenic shock have led to further development of this product in the country.

NCT ID: NCT06081205 Recruiting - Clinical trials for Acute Myocardial Infarction

Study of Patients Admitted to a Cardiac Intensive Care Unit With Acute CardioVascular Disease

Start date: April 27, 2023
Phase:
Study type: Observational

This is a registry of the patients that are admitted to CICU and treated by the Scientific Staff of the 2nd Department of Cardiology, due to an acute cardiovascular disease (acute coronary syndrome, acute heart failure, arrhythmia, pulmonary embolism, cardiac tamponade etc) in order to investigate the clinical characteristics of the patients, their outcome, identify the factors that could predict the in-hospital mortality and compare the results with the predicted by established risk scores. Furthermore, the study will investigate the one-year mortality and also the major adverse cardiac events (MACE - acute myocardial infarction, stroke, or cardiovascular death) will be measured.

NCT ID: NCT06080074 Not yet recruiting - Heart Failure Clinical Trials

Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The goal of this multicenter observational clinical trial is to evaluate the safety and effectiveness of the Cardiohelp System for VA-ECMO in children with cardiac failure. The main question[s] it aims to answer are: - What is the safety and effectiveness of the Cardiohelp device for pediatric ECMO? - What are the optimal performance specifications of the Cardiohelp device in children? Should the Cardiohelp device be FDA-cleared for children? Children who are receiving the Cardiohelp device will be approached and consented to participate if interested. Participants will undergo a standardized data collection to estimate survival to 30 days and the prevalence of serious adverse events like stroke, bleeding, and hemolysis. Outcomes will be compared to performance goals (PG) derived from the ECMO literature. Funding Source -- FDA OOPD (Office of Orphan Product Development)

NCT ID: NCT06078436 Recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

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

PACE-SHOCK
Start date: January 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06007963 Recruiting - Shock, Cardiogenic Clinical Trials

Impella in Cardiogenic Shock Registry

Impella
Start date: January 29, 2021
Phase:
Study type: Observational

The purpose of the study is to evaluate the safety, efficacy and clinical usefulness of a mechanical support strategy with the impella device.

NCT ID: NCT06006754 Recruiting - Clinical trials for Acute Myocardial Infarction

Influence of Enteral Microbiome on Mortality of Patients With Cardiogenic Shock

Start date: August 30, 2023
Phase:
Study type: Observational

Cardiogenic shock is associated with a high mortality. The microbiome is a double-edged sword which can convey protective and detrimental cardiovascular effects. The significance of the enteral micobiome on cardiovascular mortality of patients with cardiogenic shock is still not known. This study aims to provide a deeper understanding of the role of the enteral microbiome and microbiome dependent metabolites in mortality and disease progression of patients with cardiogenic shock.

NCT ID: NCT05975021 Not yet recruiting - Cardiogenic Shock Clinical Trials

A Safety and Efficacy Trial of Istaroxime for Cardiogenic Shock Stage C

SEISMiC-C
Start date: December 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The current trial aims to assess the effect of istaroxime in patients with SCAI Stage C Cardiogenic Shock (CS). These patients look unwell, frequently with a sudden change in mental status, mottled and cool extremities, and delayed capillary refill, as well as signs of congestion and relative low blood pressure and signs of hypoperfusion (reduced oxygen to organs) which frequently require support with rescue therapies including inotropes, vasopressors, or mechanical devices. Windtree Therapeutics, Inc. has been studying istaroxime, which has the potential to treat patients in this condition without some of the disadvantages of existing therapies being used to treat patients with acute heart failure and CS. Participants enrolled in this trial will receive standard of care (SoC) therapy for heart failure and CS. Additionally, half of the participants will be randomly chosen to receive istaroxime. Istaroxime has the potential to increase blood pressure and improve cardiac function.

NCT ID: NCT05930418 Recruiting - Sepsis Clinical Trials

Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis

Start date: May 20, 2023
Phase: N/A
Study type: Interventional

The overall purpose of this protocol is to identify subacute sepsis-associated cardiac disease in pediatric patients with cancer by CMR and evaluate the CMR findings during their follow-up. This will help inform heart failure management decision making. Evidence of dysfunction or elevated T2 values may inform adjustment of afterload reduction and beta blocker administration, and elevated ECV findings will suggest the need for increased surveillance for diastolic dysfunction. Primary Objectives: (Feasibility Phase) To determine the feasibility of cardiac MRI without anesthesia in the immediate post-sepsis period in children with cancer. CMR scanning will be completed within 10 days of presentation - this will allow us to ensure that possible hemodynamic or respiratory instability and renal dysfunction has resolved prior to transport to the MRI scanner during the most acute phase of illness. (Completion Phase) To estimate the frequency of subacute sepsis-associated cardiac disease, including myocardial inflammation and dysfunction, in the post-acute phase (within 10 days of presentation) of severe sepsis in children with cancer

NCT ID: NCT05913622 Recruiting - Cardiogenic Shock Clinical Trials

A Study on the Effects of Left Ventricular Unloading in the Setting of VA ECMO Support

REMAP ECMO
Start date: June 8, 2023
Phase: N/A
Study type: Interventional

REMAP ECMO is a registry based platform in which multiple response adaptive randomized clinical trials (trial domains) will be embedded. These trial domains will, in a perpetual way, study the effects of a range of patient management strategies which aim to improve VA ECMO weaning success. A first trial domain will address the effects of left ventricular (LV) unloading through intra-aortic balloon pumping on weaning succes in VA ECMO supported patients.

NCT ID: NCT05879276 Not yet recruiting - Cardiogenic Shock Clinical Trials

Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function.

EMPASHOCK
Start date: October 2023
Phase: Phase 3
Study type: Interventional

Long term prognosis of cardiogenic shock is related to the resolution of haemodynamic failure, associated visceral failure and the recovery of an adequate myocardial function. In the immediate aftermath of cardiogenic shock, after catecholamines weaning, there are no recommendations on cardiovascular treatments that would improve this long term prognosis. Indeed, the standard cardiovascular treatments such as inhibitors of the renin-angiotensin and aldosterone system and beta-blockers have hypotensive and negative inotropic effects and may worsen the renal function. In practice, given their side effects, they are not prescribed in the immediate aftermath of cardiogenic shock. Sodium-glucose co-transporter 2 (iSGLT2) inhibitors are now an integral part of the drug management of chronic heart failure and the EMPULSE-HF trial has just demonstrated a benefit in acute heart failure (PMID: 35228754). Several pivotal clinical trials have demonstrated a significant effect of iSGLT2 on the survival and the risk of re hospitalisation for heart failure (PMID: 32865377, 31535829, 33200892). Our hypothesis is that, in patients in cardiogenic shock, early treatment with Empaglifozin in addition to the standard management could reduce mortality and morbidity (death, transplantation/LVAD and rehospitalisation for heart failure) and improve myocardial function at 12 weeks, compared with standard management alone.