Unloading in Heart Failure Cardiogenic Shock

NCT ID: NCT05064202

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 456 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2028-07-01

Brief 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.

Detailed 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

Conditions

Cardiogenic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Impella 5.5

ADHF-CS patients who are in the experimental arm will be treated with an Impella 5.5 (+/- standard of care)

Group Type: EXPERIMENTAL

Impella 5.5

Intervention Type: DEVICE

temporary Mechanical Circulatory Support (tMCS)

Standard of care

ADHF-CS patients who are in the control arm will be treated with escalating doses of inotropes (standard of care)

Group Type: OTHER

Inotropes

Intervention Type: DRUG

Enoximone, Dobutamine, Dopamine, Milrinone

Interventions

Impella 5.5

temporary Mechanical Circulatory Support (tMCS)

Intervention Type: DEVICE

Inotropes

Enoximone, Dobutamine, Dopamine, Milrinone

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abiomed Inc.

INDUSTRY

Sponsor Role: collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role: lead

Responsible Party

Alexander Nap

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Nap, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

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, , Netherlands

Countries

Netherlands

Central Contacts

Alexander Nap, MD PhD

Role: CONTACT

a.nap@amsterdamumc.nl

+31(0)614102081

Facility Contacts

Jose PS Henriques, MD PhD

Role: primary

Alexander Nap, MD PhD

Role: primary

Kevin Damman, MD PhD

Role: primary

Jose Montero-Cabezas, MD PhD

Role: primary

Other Identifiers

NL84199.018.23

Identifier Type: -

Identifier Source: org_study_id