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Evaluation of the Impact of eGFR Decline on Clinical Practice Patterns of Medication Withdrawal in Heart Failure

Award Number: R03DK145928
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2028

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Evaluation of the Impact of eGFR Decline on Clinical Practice Patterns of Medication Withdrawal in Heart Failure - PROJECT SUMMARY/ABSTRACT Heart failure (HF) is a condition that carries very high rates of mortality and morbidity. Guideline-directed medical therapy (GDMT) including renin-angiotensin-aldosterone system inhibitors (RAASi), mineralocorticoid receptor antagonists (MRA), and sodium-glucose co-transporter 2 inhibitors (SGLT2i) have each been shown to reduce mortality and risk of adverse cardiovascular events, particularly for patients with heart failure with reduced ejection fraction (HFrEF). However, each of these GDMT medication classes is also associated with an acute decline in estimated glomerular filtration rate (eGFR) which is considered hemodynamic and benign in nature. For clinicians, however, the eGFR decline following initiation of GDMT appears no different from eGFR decline due to true kidney injury, creating a significant degree of clinical angst over whether to discontinue or reduce the dose of the GDMT, which would potentially place the patient at higher risk of worsening cardiovascular function. Despite several large clinical trials showing the significant mortality and cardiovascular benefits of GDMT, rates of GDMT prescribing remain low, and rates of early GDMT discontinuation are high, with many clinicians citing concerns for eGFR decline as a large obstacle to initiation and continuation of GDMT. Designing a study to determine whether discontinuation of GDMT following eGFR decline is harmful for patients is very challenging for several reasons. First, the eGFR fluctuates frequently in HFrEF both due to GDMT medications but also due to other causes. Second, with three separate classes of GDMT agents to be used in combination, there quickly become many iterations of different combinations of continuation, discontinuation, or dose change of both newly introduced (new use) GDMT as well as of previously prescribed (prevalent use) GDMT agents. The overall goal of this proposal is to use the Stockholm CREATinine Measurement (SCREAM) cohort, a regional health utilization cohort with complete pharmacy dispensation records, to describe prescribing patterns of RAASi, MRA, and SGLT2i among patients with HF. We plan to examine eGFR changes after GDMT initiation, their association with risk of cardiovascular death and hospitalizations for HF within the context of which agent and how many combined GDMT class agents are initiated. Based on incidence of eGFR decline or not, we will then assess all the combinations of GDMT continuation, discontinuation, dose reduction or dose increase. These results will serve as preliminary data to inform design of appropriate future larger trials, including a target trial designed to emulate randomization of patients to GDMT continuation vs discontinuation following eGFR decline with the ultimate goal of increasing rates of GDMT prescribing in order to improve mortality and cardiovascular outcomes among patients with HF.


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 = $133,875 )
2026	2026	TUFTS MEDICAL CENTER PARENT, INC.	800 WASHINGTON ST	BOSTON	MA	02111	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	8/26/2026	NEW	$133,875
														Subtotal = $133,875

Grand Total All Awards = $133,875

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Evaluation of the Impact of eGFR Decline on Clinical Practice Patterns of Medication Withdrawal in Heart Failure

Award Number: R03DK145928

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2028

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