Wednesday, July 16, 2025 7/16/2025

Biomarkers of Kidney Secretory Function for Discriminating Risk of Hyperkalemia

Award Number: R21HL169633
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2023
PERIOD OF PERFORMANCE END DATE: 06/30/2026

Group Awards By:

View Award Description

Biomarkers of Kidney Secretory Function for Discriminating Risk of Hyperkalemia - PROJECT SUMMARY Hyperkalemia is a common and potentially life-threatening electrolyte disturbance. The risk of hyperkalemia is higher in individuals with heart failure (HF) and chronic kidney disease and with the use of certain medications, such as spironolactone. Current methods to identify individuals at increased risk of hyperkalemia are rudimentary. Potassium is primarily eliminated by the kidneys through glomerular filtration and tubular secretion, but currently only glomerular filtration is considered when evaluating risk for hyperkalemia. Novel biomarkers of kidney tubular secretion have been strongly linked with tubule fibrosis and we have recently demonstrated that a lower secretion score, a composite score from secretion biomarkers, is associated with a higher risk of incident hyperkalemia. Many medications, such as spironolactone, are eliminated through secretion. Kidney tubule secretion biomarkers have been associated with the clearance of medications dependent on kidney secretion for elimination. The Spironolactone for Heart Failure with Preserved Ejection Fraction (TOPCAT) trial is a multicenter international clinical trial that enrolled 3445 patients with HFpEF and randomized participants to spironolactone versus placebo. In TOPCAT, rates of hyperkalemia were 18.7% in spironolactone arm and 9.1% in the placebo arm. In this TOPCAT ancillary study, we will measure kidney tubule secretion biomarkers with the specific aims to: 1) determine if a novel panel of tubular secretion biomarkers identifies HF patients at higher risk for hyperkalemia in TOPCAT, and 2) determine if tubule secretion biomarkers are associated with improvements in heart failure symptoms and natriuretic peptide levels from spironolactone therapy among HF patients in TOPCAT. The results of this study will provide evidence for an innovative method to risk stratify individuals for risk of hyperkalemia prior to starting hyperkalemia provoking medications, and lead to a new line of investigation wherein we move secretion biomarkers from research towards clinical practice with the ultimate goal of maximizing benefits while minimizing risks of drug dosing and drug-drug interactions for secreted drugs.


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: 2025 ( Subtotal = $0 )
2025	2024	VETERANS MEDICAL RESEARCH FOUNDATION OF SAN DIEGO	3350 LA JOLLA VILLAGE DR	SAN DIEGO	CA	92161	SAN DIEGO	USA	Cardiovascular Diseases Research	000	2	6/20/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $109,613 )
2024	2024	VETERANS MEDICAL RESEARCH FOUNDATION OF SAN DIEGO	3350 LA JOLLA VILLAGE DR	SAN DIEGO	CA	92161	SAN DIEGO	USA	Cardiovascular Diseases Research	000	2	7/2/2024	NON-COMPETING CONTINUATION	$109,613
														Subtotal = $109,613

Issue Date FY: 2023 ( Subtotal = $123,088 )
2023	2023	VETERANS MEDICAL RESEARCH FOUNDATION OF SAN DIEGO	3350 LA JOLLA VILLAGE DR	SAN DIEGO	CA	92161	SAN DIEGO	USA	Cardiovascular Diseases Research	000	1	8/15/2023	NEW	$123,088
														Subtotal = $123,088

Grand Total All Awards = $232,701

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Biomarkers of Kidney Secretory Function for Discriminating Risk of Hyperkalemia

Award Number: R21HL169633

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/15/2023

PERIOD OF PERFORMANCE END DATE: 06/30/2026

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer