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Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM)

Award Number: R01HL144624
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/10/2019
PERIOD OF PERFORMANCE END DATE: 05/31/2025

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Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM) - Project Summary/Abstract Sepsis results when the host response to infection—comprising both immune and stress responses—leads to organ dysfunction, centrally cardiovascular dysfunction. The resulting sepsis-associated hypotension is lethal; how best to treat it is currently unknown. The two main treatments—intravenous fluid and catecholamine vasopressor infusions—both have toxicities, including direct effects on the heart, thus contributing to what is often termed septic cardiomyopathy. A large NIH/NHLBI-funded clinical trial, Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis (CLOVERS), randomizes patients to competing strategies for treating sepsis-associated hypotension: liberal fluids (≥5L fluids before vasopressors) or early vasopressors (immediate vasopressors without additional fluids). CLOVERS represents an ideal laboratory for understanding the effects of management strategies on the evolution of septic cardiomyopathy, the relative contributions of right ventricular (RV) and left ventricular (LV) impairment to outcomes from septic cardiomyopathy, and the implications of baseline echocardiographic findings for the effect of treatments in certain groups of people. The Study of Treatment’s Echocardiographic Mechanisms (CLOVERS-STEM) is a prospective observational ancillary study within CLOVERS. Study subjects (N=210) will undergo speckle-tracked echocardiograms at enrollment and 24 hours later. Three integrated aims employ robust echocardiographic measures to assess the evolution of septic cardiomyopathy and differential susceptibility to treatment. Aim 1 assesses whether the early vasopressor treatment leads to LV impairment at 24 hours, as measured by global longitudinal strain. Aim 2 assesses whether the early vasopressor treatment leads to RV impairment, as measured by the ratio of RV to LV end-diastolic areas and RV free wall longitudinal strain. These two aims will also explore the contributions of LV and RV impairment to clinical endpoints. Aim 3 uses a validated continuous surrogate outcome—the change in multiple organ dysfunction on day 3—to explore possible heterogeneity of treatment effect based on the baseline echocardiographic results. This project innovates in multiple respects to dramatically advance our understanding of a major cause of global morbidity and mortality.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2022	IHC HEALTH SERVICES INC	36 S STATE ST	SALT LAKE CITY	UT	84111	SALT LAKE	USA	Lung Diseases Research	000	4	12/4/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	INTERMOUNTAIN HEALTH CARE, INC.	36 S STATE ST STE 2200	SALT LAKE CITY	UT	84111	SALT LAKE	USA	Lung Diseases Research	000	4	6/15/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $163,054 )
2022	2022	INTERMOUNTAIN HEALTH CARE, INC.	36 S STATE ST STE 1600	SALT LAKE CITY	UT	84111	SALT LAKE	USA	Lung Diseases Research	000	4	6/24/2022	NON-COMPETING CONTINUATION	$163,054
														Subtotal = $163,054

Issue Date FY: 2021 ( Subtotal = $498,997 )
2021	2021	INTERMOUNTAIN HEALTH CARE, INC.	36 S STATE ST STE 1600	SALT LAKE CITY	UT	84111	SALT LAKE	USA	Lung Diseases Research	000	3	6/18/2021	NON-COMPETING CONTINUATION	$498,997
														Subtotal = $498,997

Issue Date FY: 2020 ( Subtotal = $520,854 )
2020	2020	INTERMOUNTAIN HEALTH CARE, INC.	36 S STATE ST STE 1600	SALT LAKE CITY	UT	84111	SALT LAKE	USA	Lung Diseases Research	000	2	6/3/2020	NON-COMPETING CONTINUATION	$520,854
														Subtotal = $520,854

Issue Date FY: 2019 ( Subtotal = $604,274 )
2019	2019	INTERMOUNTAIN HEALTH CARE, INC.	36 S STATE ST STE 1600	SALT LAKE CITY	UT	84111	SALT LAKE	USA	Lung Diseases Research	000	1	6/7/2019	NEW	$604,274
														Subtotal = $604,274

Grand Total All Awards = $1,787,179

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Study of Treatment's Echocardiographic Mechanisms (CLOVERS-STEM)

Award Number: R01HL144624

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/10/2019

PERIOD OF PERFORMANCE END DATE: 05/31/2025

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