Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
Location status: Recruiting
Location contact
Bhruga Shah, MS, BSN
CONTACT
Kedir Seid
CONTACT
Shashank Sinha, MD MSc
PRINCIPAL_INVESTIGATOR
NCT Number: NCT04419480
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Falls Church, Virginia, 22042, United States
Location status: Recruiting
Bhruga Shah, MS, BSN
CONTACT
Kedir Seid
CONTACT
Shashank Sinha, MD MSc
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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.
Time frame: 6 months
All-cause mortality from enrollment.
Time frame: 6 months
Time to first all-cause mortality or cardiovascular hospitalization.
Time frame: 6 months
Time to all-cause hospitalization.
Time frame: 6 months
Time to all unscheduled hospital visits (including Emergency Department and Outpatient Diuretic Infusion Clinic)
Time frame: 6 months
Change in NT-pro-B-type natriuretic peptide (NT-pro-BNP) from enrollment to 6 months follow up.
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.
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.
Contact information is provided by the study sponsor or research team.
Bhruga Shah, MPH
CONTACT
Shashank Sinha, MD MSc
CONTACT
Inova Health Care Services
Other
Acronym: HALO-Shock
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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