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INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery

ConditionsHeart FailureCardiogenic ShockReduced Ejection Fraction Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAbiomed Inc.

About this trial

The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 and < 80 years

Subject or subject's legally authorized representative (LAR) has signed the Informed Consent Form

LVEF ≤ 40%

Hypotension (sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for inotropic/vasoactive agents to maintain such blood pressure)

Disqualifiers

Drug allergies or hypersensitivities* to HF GDMT medications, unless alternative can be identified

Known bilateral renal artery stenosis

Type 1 diabetes

2o or 3o AV block, unless pacemaker is in place

Trial design

Design model

Single group

Treatments tested in this trial

  • Impella 5.5 SmartAssist

    Device

    The intervention is Impella 5.5 with SmartAssist® support combined with protocolized guideline directed medical therapy (GDMT) and HF-CS best practices.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Single arm studyOther 1 intervention

Trial outcomes

Primary outcomes

1

Composite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation)

Time frame
Timeframe: 180-days post-enrollment

Secondary outcomes

1

Composite of all-cause death and heart replacement

Time frame
90-days, 180-days, 1-year post-enrollment
2

Composite of all-cause death, HF hospitalization, and heart replacement

Time frame
90-days, 1-year post-enrollment
3

All-cause mortality

Time frame
Hospital Discharge (within 24 hours) , 90-days, 180-days, 1-year post-enrollment
4

Cardiovascular mortality

Time frame
Hospital Discharge (within 24 hours), 90-days, 180-days, 1-year post-enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abiomed Inc.

Lead sponsor

Johnson & Johnson

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: