Back to resultsHemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial (HALO-Shock)
Primary Purpose
Cardiogenic Shock, Heart Failure, Ambulatory Hemodynamic Monitoring
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization
Sponsored by
About this trial
This is an interventional treatment trial for Cardiogenic Shock
Eligibility Criteria
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.
Sites / Locations
- Inova Fairfax Medical Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CardioMEMS Implant Group
Non-CardioMEMS Implant Group
Arm Description
Following enrollment, patients randomized 1:1 to post-discharge implantation of the CardioMEMS device will receive that device ≤14 days following discharge from the index hospitalization for Cardiogenic Shock, in addition to local standard of care medical therapy.
Following enrollment, patients randomized 1:1 to post-discharge standard of care will be treated according to local standard of care medical therapy following their index hospitalization for Cardiogenic Shock.
Outcomes
Primary Outcome Measures
Hierarchical primary endpoint
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 Outcome Measures
Health related quality of life change from baseline
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.
All-cause mortality
All-cause mortality from enrollment.
All-cause mortality or cardiovascular hospitalization
Time to first all-cause mortality or cardiovascular hospitalization.
All-Cause Hospitalization
Time to all-cause hospitalization.
Unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)
Time to all unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)
Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP)
Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP) from enrollment to 6 months follow up.
Achieved guideline directed medical therapy for heart failure
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.
Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitoring.
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.
Full Information
NCT ID
NCT04419480
First Posted
June 3, 2020
Last Updated
January 27, 2023
Sponsor
Inova Health Care Services
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT04419480
Brief Title
Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
Acronym
HALO-Shock
Official Title
Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 31, 2020 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services
Collaborators
Abbott
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock, Heart Failure, Ambulatory Hemodynamic Monitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CardioMEMS Implant Group
Arm Type
Experimental
Arm Description
Following enrollment, patients randomized 1:1 to post-discharge implantation of the CardioMEMS device will receive that device ≤14 days following discharge from the index hospitalization for Cardiogenic Shock, in addition to local standard of care medical therapy.
Arm Title
Non-CardioMEMS Implant Group
Arm Type
No Intervention
Arm Description
Following enrollment, patients randomized 1:1 to post-discharge standard of care will be treated according to local standard of care medical therapy following their index hospitalization for Cardiogenic Shock.
Intervention Type
Device
Intervention Name(s)
CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization
Intervention Description
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 Outcome Measure Information:
Title
Hierarchical primary endpoint
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Health related quality of life change from baseline
Description
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.
Time Frame
2 months and 6 months
Title
All-cause mortality
Description
All-cause mortality from enrollment.
Time Frame
6 months
Title
All-cause mortality or cardiovascular hospitalization
Description
Time to first all-cause mortality or cardiovascular hospitalization.
Time Frame
6 months
Title
All-Cause Hospitalization
Description
Time to all-cause hospitalization.
Time Frame
6 months
Title
Unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)
Description
Time to all unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)
Time Frame
6 months
Title
Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP)
Description
Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP) from enrollment to 6 months follow up.
Time Frame
6 months
Title
Achieved guideline directed medical therapy for heart failure
Description
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.
Time Frame
6 months
Title
Safety of early post-discharge implantation of a pulmonary artery hemodynamic monitoring.
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shashank Sinha, MD MSc
Organizational Affiliation
Inova Fairfax Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Fairfax Medical Campus
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial
We'll reach out to this number within 24 hrs