Monitoring heart function to prevent complications after cardiogenic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial investigates the use of pulmonary artery hemodynamic monitoring in patients who have experienced cardiogenic shock. Participants will receive CardioMEMS implantation for continuous monitoring of pulmonary artery pressure, alongside medication optimization. The study aims to assess whether this approach can improve patient outcomes following hospitalization for cardiogenic shock. It is a randomized, unblinded trial designed to gather preliminary data on the effectiveness of this monitoring strategy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject or legal representative has signed Informed Consent Form (ICF) and the patient has the capacity to participate in the study and complete the study questionnaires, in the estimation of the study investigator.
2. Age ≥ 18 years
3. NYHA Class III with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (LVEF).
4. Survive to discharge during a current hospital admission with cardiogenic shock (CS) as defined by clinical criteria previously used in cardiogenic shock trials: systolic blood pressure \< 90 mmHg for \> 30 minutes or requiring infusion of catecholamines to maintain the systolic blood pressure above 90 mmHg, with evidence of end-organ dysfunction such as pulmonary edema or impaired end-organ perfusion including altered mentation, oliguria with urine output \< 30 mL/h, or serum lactate \> 2 mmol/L (5). Hemodynamic criteria include cardiac index ≤ 1.8 L/min/m2 without vasoactive pharmacologic agents, or cardiac index ≤ 2.2 L/min/m2 and pulmonary artery occlusion pressure ≥ 15 mmHg with vasoactive agents.
5. Patients must have internet and phone access (to allow communication of the implanted device with the researchers).

Exclusion Criteria:

1. Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator.
2. Treatment with ongoing mechanical circulatory support (MCS) such as a durable left ventricular assist device (LVAD) or recipient of a heart transplantation for the treatment of cardiogenic shock during the index hospitalization for CS.
3. If of childbearing potential with a positive pregnancy test.
4. Transition to hospice care.
5. Intolerance to or inability to adhere to antiplatelet therapy for 1 year after device implantation.
6. Presence of an active, uncontrolled infection.
7. Any condition other than heart failure that could limit survival to less than 6 months
8. Discharge to facility other than acute rehabilitation or to the ambulatory setting.
9. No access to internet or phone.

Where it's running

• Inova Fairfax Medical Campus
  Falls Church, Virginia, United States Recruiting

Study contacts

• Principal investigator: Shashank Sinha, MD MSc — Inova Fairfax Medical Campus
• Study coordinator: Shashank Sinha, MD MSc
• Email: shashank.sinha@inova.org
• Phone: 7037764001

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Prolonged nasogastric ketone infusion for decompensated heart failure

  This will test whether a continuous nasogastric infusion of a ketone (D‑beta‑hydroxybutyrate) can safely reach target blood levels in adults with severely reduced ejection fraction admitted for acute decompensated heart failure or cardiogenic shock.

  Recruiting Phase 4 Institute for Clinical and Experimental Medicine · Prague, Prague · NCT07527156

• Magenta Elevate™ device for cardiogenic shock

  This trial tries the Magenta Elevate™ device to see if it can safely support people with cardiogenic shock caused by left ventricular failure.

  Recruiting at 8 sites Magenta Medical Ltd. · Tbilisi and 7 other locations · NCT07293923

• Initiation and Titration of GDMT with Impella 5.5 in Heart Failure with Cardiogenic Shock

  This study tests a device-plus-drug strategy using the Impella 5.5 alongside optimized guideline-directed medical therapy to see if heart recovery improves in adults with decompensated heart failure and cardiogenic shock.

  Recruiting at 2 sites Abiomed Inc. · Tampa, Florida and 16 other locations · NCT06965504

• Impact of lower vasopressor use on survival in patients with heart failure on ECMO

  This study is testing if using less vasopressor medication can help adults with heart failure on ECMO survive better over 30 days.

  Recruiting Beijing Anzhen Hospital · Beijing, Beijing Municipality · NCT06862700

• Using Apple Watch data to predict heart failure outcomes

  This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

  Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

• Assessing muscle thickness changes in heart failure patients

  This study is testing how muscle thickness changes in heart failure patients receiving advanced treatments like heart transplants or assist devices to see how it affects their recovery.

  Recruiting Tufts Medical Center · Boston, Massachusetts · NCT06253104

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.