Heart Disease Trial, Recruiting NCT03836482 Sponsor: SeaStar Medical Condition: Heart Disease
Back to Heart Disease

Heart Disease Trial, Recruiting

NCT03836482
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 years or older
  • People who have blood test results showing signs of inflammation in the body (specific markers include CRP, IL-6, or a white blood cell ratio — the trial site can confirm what these mean for a specific case)
  • People who are currently hospitalised mainly because their chronic heart failure has suddenly gotten worse (known as acute decompensated chronic systolic heart failure)
  • People who are being considered as a possible candidate for a heart pump device called an LVAD, with a weakened heart pumping function confirmed by imaging, severe heart failure symptoms that have not improved with the best available medicines over at least 45 of the last 60 days, and a very limited ability to exercise or a need for a temporary heart support device or medicines given through a drip to keep the heart working
  • People whose kidneys are functioning at a sufficient level, with a kidney function score (eGFR) of at least 40 within the past 90 days
  • People who have either severe right-sided heart failure or worsening kidney function linked to their heart condition, with specific measurements taken through a heart catheter confirming this (the trial site can clarify the exact thresholds)
  • People who already have a special heart monitoring catheter (called a PA catheter) in place at the time of joining the trial
  • People with a specific heart pressure reading (pulmonary capillary wedge pressure) of at least 20 mmHg

Who may not be able to join:

  • People who have a clear medical reason why an LVAD heart pump would not be suitable for them, and where that reason is unlikely to improve
  • People who have had a previous allergic or sensitivity reaction to components used in dialysis equipment
  • People who have an active bacterial infection in the bloodstream
  • People with a high fever (38.6°C / 101.5°F or above), a high white blood cell count, or any suspected active infection throughout the body
  • People with a cancer that has spread to other parts of the body and requires chemotherapy, biological therapy, or radiation treatment
  • People who need certain strong blood pressure-raising medications given through a drip, or a particular heart stimulating medication above a specific dose (confirm exact medications and doses with the trial site)
  • People who need a machine to help them breathe
  • People who need nutrition delivered entirely through a drip into a vein during the treatment period
  • People with persistently very low blood pressure (systolic blood pressure below 80 mmHg)
  • People with a low white blood cell count below a certain threshold
  • People with a low platelet count below a certain threshold
  • People with very poor kidney function (creatinine above 4 mg/dL) or who are already receiving dialysis or continuous kidney replacement therapy
  • People who have had a heart attack or acute coronary event within the past month
  • People who are pregnant, breastfeeding, or actively trying to become pregnant
  • People who are already participating in another clinical trial that involves a test drug or device
  • People who have used any other experimental drug or device within the past 30 days (participation in studies involving only measurements or sample collection is generally permitted — confirm with the trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
SeaStar Medical
Registry
ClinicalTrials.gov
Start date
2 October 2025
Est. completion
1 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Need for continuous IV vasopressor support; Acute myocardial infarction; Mortality; Percentage of subjects with reversal of WRF and increase eGFR and PCW; Percentage of subjects who no longer have severe right ventricular failure; Adverse Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov