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NCT Number: NCT04419480

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Age ≥ 18 years
  • NYHA Class III with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (LVEF).
  • 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.
  • Patients must have internet and phone access (to allow communication of the implanted device with the researchers).

Exclusion criteria

  • Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator.
  • 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.
  • If of childbearing potential with a positive pregnancy test.
  • Transition to hospice care.
  • Intolerance to or inability to adhere to antiplatelet therapy for 1 year after device implantation.
  • Presence of an active, uncontrolled infection.
  • Any condition other than heart failure that could limit survival to less than 6 months
  • Discharge to facility other than acute rehabilitation or to the ambulatory setting.
  • No access to internet or phone.

Treatment and study plan

CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization

Device

Implantation of CardioMEMS Device in patients following admission for Cardiogenic shock, with regular ambulatory pulmonary artery pressure monitoring and medication optimization for the treatment of heart failure.

Primary outcomes

  1. Hierarchical primary endpoint

    Time frame: 6 months

    Hierarchical endpoint at 6-months, including death (or mortality-equivalent including left ventricular assist device implantation or heart transplantation), recurrent cardiovascular hospitalization, health related quality of life change from baseline, measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) as a continuous score, and change in log-transformed NT-proBNP level from enrollment to 6 months, evaluated by the win ratio according to the Finkelstein-Schoenfeld method

Secondary outcomes

  1. Health related quality of life change from baseline

    Time frame: 2 months and 6 months

    Health related quality of life change from baseline, measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) as a continuous score at 2 months and 6 months following admission for CS.hemodynamic monitor is safe in the high-risk CS population.

  2. All-cause mortality

    Time frame: 6 months

    All-cause mortality from enrollment.

  3. All-cause mortality or cardiovascular hospitalization

    Time frame: 6 months

    Time to first all-cause mortality or cardiovascular hospitalization.

  4. All-Cause Hospitalization

    Time frame: 6 months

    Time to all-cause hospitalization.

  5. Unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)

    Time frame: 6 months

    Time to all unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)

  6. Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP)

    Time frame: 6 months

    Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP) from enrollment to 6 months follow up.

  7. Achieved guideline directed medical therapy for heart failure

    Time frame: 6 months

    Achieved guideline directed medical therapy for heart failure with reduced ejection fraction at 6 months, measured by achievement of >50% of the guideline targeted optimal dosing of angiotensin receptor blocker or angiotensin converting enzyme inhibitor or angiotensin receptor neprilysin inhibitor, beta-blocker, and mineralocorticoid receptor antagonist.

  8. Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitoring.

    Time frame: 6 months

    Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitor in the high-risk CS population, including device-related or system-related complications or pressure-sensor failures.

Study contacts

Contact information is provided by the study sponsor or research team.

Bhruga Shah, MPH

CONTACT

[email protected]

17037762828

Shashank Sinha, MD MSc

CONTACT

[email protected]

7037764001

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Collaborators

  • Abbott

Registry information

Acronym: HALO-Shock

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jun 5, 2020
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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