Unloading in Heart Failure Cardiogenic Shock

Cardiogenic Shock Clinical Trial

— UNLOAD HF-CS  

Official title:

Use of mechaNical Left ventricuLar unlOading in Acute decompensateD Heart Failure Complicated by Cardiogenic Shock - the UNLOAD HF-CS Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05064202
• Other study ID #: NL84199.018.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: July 1, 2028

Study information

• Verified date: July 2023
• Source: Amsterdam UMC, location VUmc
• Contact: Alexander Nap, MD PhD
• Phone: +31(0)614102081
• Email: a.nap[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to evaluate whether timely and aggressive temporary Mechanical Circulatory Support (tMCS) through the Impella 5.5® in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) has the potential to reduce the HF-CS related clinical events compared to the current standard of care.

Description:

To demonstrate the efficacy of timely temporary mechanical left ventricular unloading with the Impella 5.5® assist device in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) vs. current standard of (pharmacological) care

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 456
• Est. completion date: July 1, 2028
• Est. primary completion date: October 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Evidence of HFrEF according to ESC HF guidelines (LVEF = 35%) 2. Signs of (persistent) congestion (elevated CVP, edema, rales, ascites, pleural effusion) 3. Evidence of CS with presence of at least 2 of the 3 following:

1. Hypotension

1. systolic blood pressure <90 mmHg for at least 30 min OR

2. mean arterial pressure <60 mmHg for at least 30 min

2. Hypoperfusion

1. lactate > 2.0 mmol/L (two consecutive values > 2 mmol/L with at least 30 min between samples, with non-decreasing trend on if on (steady doses of) inotropes and/or vasopressors)

2. amino-L-transferase >200 U/L (two consecutive values > 200 Ul/L with at least 30 min between samples, with non-decreasing trend if on (steady doses of) inotropes and/or vasopressors)

3. creatinine rise = 0.3 mg/dl/24h ( 26,53 µmol/L)

4. oliguria (= 0,5 ml/kg/h, = 720 ml/24 h)

3. Inotropes/vasoactives (use of)

Exclusion Criteria:

1. Contraindications for Impella 5.5

2. Severe concomitant RV failure

3. Grade IV mitral regurgitation eligible for surgical treatment

4. Dialysis for end-stage renal failure

5. Acute coronary syndrome (type 1, AMI)

6. Bradycardia and AV blocks necessitating pacemaker implantation

7. HD parameters and biochemistry alterations as specifically defined for SCAI CS E

8. Combined cardiorespiratory failure

9. Resuscitated (OHCA/PEA)

10. History of CVA or TIA within previous 90 days

11. History of acute myocardial infarction within previous 30 days

12. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions

13. Inflammatory

14. Active systemic infections

15. Acute myocarditis

Related Conditions & MeSH terms

• Cardiogenic Shock
• Heart Failure
• Shock
• Shock, Cardiogenic

Intervention

Device:
• Impella 5.5
temporary Mechanical Circulatory Support (tMCS)

Drug:
• Inotropes
Enoximone, Dobutamine, Dopamine, Milrinone

Locations

Country	Name	City	State
Netherlands	Academical Medical Center (AMC)	Amsterdam
Netherlands	VU University Medical Center (VUMC)	Amsterdam
Netherlands	Univerity Medical Center Groningen (UMCG)	Groningen
Netherlands	Leids Universitair Medisch Centrum (LUMC)	Leiden
Netherlands	University Medical Center Utrecht (UMCU)	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc	Abiomed Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause mortality, renal replacement therapy and rehospitalization or urgent visit for heart failure (Efficacy - Primary Combined Clinical Endpoint)	Number of patients suffering from any of: all-cause death, renal replacement therapy and rehospitalization or urgent hospital visit for heart failure up to 90 days	baseline to 90 days
Secondary	In-hospital mortality (Efficacy - Secondary Endpoint)	Number of patients suffering from cardiac death and non-cardiac death and undetermined death during hospitalisation	baseline to 28 days
Secondary	In-hospital Worsening Heart Failure (Efficacy - Secondary Endpoint)	Number of patients with progression to SCAI CS stage D OR E (depending on stage directly after randomization)	baseline to 28 days
Secondary	Cardiac mortality (Efficacy - Secondary Endpoint)	Number of patients that died of any cause at 90 days and 1 year	baseline to 1 year
Secondary	All-cause mortality (Efficacy - Secondary Endpoint)	Number of patients that died of any cause at 90 days and 1 year	baseline to 1 year
Secondary	Mechanical ventillation (Efficacy - Secondary Endpoint)	Number of patients that were mechanically ventilated during hospitalization, up to day 90 and 1 year	baseline to 1 year
Secondary	Renal replacement therapy (Efficacy - Secondary Endpoint)	Number of patients that received renal replacement therapy during hospitalization, up to day 90 and 1 year	baseline to 1 year
Secondary	Hospitalization or urgent hospital visit for heart failure (Efficacy - Secondary Endpoint)	Number of patients that were hospitalized or had an urgent hospital visit for heart failure up to day 30, 60 and 1 year	baseline to 1 year
Secondary	Urgent / rescue MCS implantation (permanent) (Efficacy - Secondary Endpoint)	Number of patients that received a permanent MCS device implantation up to day 90 and 1 year	baseline to 1 year
Secondary	Hospitalization time (Efficacy - Secondary Endpoint)	Lenght of index hospitalization for HF-CS in days	baseline to 28 days
Secondary	Vasoactive Inotropic Score (maximal) (Efficacy - Secondary Endpoint)	Maximal VIS during hospitalization	baseline to 28 days
Secondary	LVAD / Heart transplantation (Efficacy - Secondary Endpoint)	Number of patients that received heart treplacement therapy up to discharge, 90 days and 1 year	baseline to 1 year
Secondary	KCCQ-12 (Efficacy - Secondary Endpoint)	Average KCCQ-12 at 90 days and 1 year	90 days, 1 year
Secondary	Stroke or TIA (Safety - Secondary Endpoint)	Number of patients that developed a stroke or TIA up to discharge	baseline to 28 days
Secondary	Major Bleeding (Safety - Secondary Endpoint)	Number of patients that developed a major bleed up to discharge	baseline to 28 days
Secondary	Major vascular events (Safety - Secondary Endpoint)	Number of patients that developed a major vascular event up to discharge	baseline to 28 days
Secondary	Extremity ischemia (Safety - Secondary Endpoint)	Number of patients that developed limb ischemia up to discharge	baseline to 28 days
Secondary	Hemolysis (Safety - Secondary Endpoint)	Number of patients diagnosed with hemolysis up to discharge	baseline to 28 days
Secondary	Insertion site infection (Safety - Secondary Endpoint)	Number of patients that developed an infection at the insertion site up to discharge	baseline to 28 days
Secondary	Aortic valve injury (Safety - Secondary Endpoint)	Number of patients that developed aortic valve insufficiency (by echo) up to day 90	baseline to 90 days