Unloading in Heart Failure Cardiogenic Shock

NCT05064202 | Not Yet Recruiting

• 1 other identifier: NL84199.018.23
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 5

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.

Conditions

Cardiogenic Shock

Keywords

Unloading; Acute Decompensated Heart Failure; Cardiogenic Shock; temporary Mechanical Circulatory Support (tMCS); Inotropes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• In-hospital mortality (Efficacy - Secondary Endpoint)

  baseline to 28 days

• In-hospital Worsening Heart Failure (Efficacy - Secondary Endpoint)

  baseline to 28 days

• Cardiac mortality (Efficacy - Secondary Endpoint)

  baseline to 1 year

• All-cause mortality (Efficacy - Secondary Endpoint)

  baseline to 1 year

• Mechanical ventillation (Efficacy - Secondary Endpoint)

  baseline to 1 year

Study Arms (2)

Impella 5.5

EXPERIMENTAL

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

Device: Impella 5.5

Standard of care

OTHER

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

Drug: Inotropes

Interventions

Impella 5.5 DEVICE

temporary Mechanical Circulatory Support (tMCS)

Impella 5.5

Inotropes DRUG

Enoximone, Dobutamine, Dopamine, Milrinone

Standard of care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• Hypotension
• systolic blood pressure \<90 mmHg for at least 30 min OR
• mean arterial pressure \<60 mmHg for at least 30 min
• Hypoperfusion
• 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)
• 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)
• creatinine rise ≥ 0.3 mg/dl/24h ( 26,53 μmol/L)
• oliguria (≤ 0,5 ml/kg/h, ≤ 720 ml/24 h)
• Inotropes/vasoactives (use of)

You may not qualify if:

• Contraindications for Impella 5.5
• Severe concomitant RV failure
• Grade IV mitral regurgitation eligible for surgical treatment
• Dialysis for end-stage renal failure
• Acute coronary syndrome (type 1, AMI)
• Bradycardia and AV blocks necessitating pacemaker implantation
• HD parameters and biochemistry alterations as specifically defined for SCAI CS E
• Combined cardiorespiratory failure
• Resuscitated (OHCA/PEA)
• History of CVA or TIA within previous 90 days
• History of acute myocardial infarction within previous 30 days
• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions
• Inflammatory
• Active systemic infections
• Acute myocarditis

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Abiomed Inc.: collaborator

Study Sites (5)

Academical Medical Center (AMC)

Amsterdam, Netherlands

Location

VU University Medical Center (VUMC)

Amsterdam, Netherlands

Location

Univerity Medical Center Groningen (UMCG)

Groningen, Netherlands

Location

Leids Universitair Medisch Centrum (LUMC)

Leiden, Netherlands

Location

University Medical Center Utrecht (UMCU)

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Alexander Nap, MD PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Nap, MD PhD

CONTACT

+31(0)614102081; a.nap@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: October 1, 2021
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (5)