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Aldosterone, the Mineralocorticoid Receptor, and Cardiovascular Disease in Obesity

Award Number: R01HL153004
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Aldosterone, the Mineralocorticoid Receptor, and Cardiovascular Disease in Obesity - PROJECT ABSTRACT Obesity is a rapidly expanding epidemic that is arguably the leading cause of cardiovascular disease. Obese individuals have increased autonomous aldosterone production resulting in excessive activation of the mineralocorticoid receptor that increases the risk for myocardial fibrosis and ischemia, hypertension, and stroke. Since mineralocorticoid receptor antagonists are widely available and safe medications, autonomous aldosterone production represents a modifiable mechanism to prevent cardiovascular disease in obesity. We hypothesize that mineralocorticoid receptor antagonists can improve myocardial perfusion and fibrosis in obese individuals. We propose a mechanistic clinical trial that involves deep phenotyping of aldosterone physiology and cardiac MRI imaging to evaluate this hypothesis. Participants with high-risk obesity, defined as obesity with untreated hypertension and/or one or more features of the metabolic syndrome, will be enrolled. Participants will undergo a deep-phenotyping protocol to characterize aldosterone physiology, and cardiac MRI to measure myocardial perfusion reserve (to assess coronary microvascular function) and extracellular volume fraction (to assess myocardial fibrosis), before double-blinded randomization to eplerenone (a mineralocorticoid receptor antagonist and potassium-sparing diuretic) or chlorthalidone (a conventional blood pressure medication and potassium-wasting diuretic) along with potassium chloride for one year. During this year, blood pressure and potassium will be maintained in a target range to ensure outcomes are independent of these variables. Cardiac MRI-derived outcomes will be measured again after one year of the randomized intervention. It is anticipated that eplerenone therapy will improve measures of coronary microvascular function and fibrosis, independent of blood pressure, when compared to chlorthalidone with potassium. This mechanistic study is designed to investigate a targeted treatment for the prevention of cardiovascular disease in high-risk obesity using innovative hormonal phenotyping and sophisticated imaging outcomes. If our hypothesis is correct, this study may justify the early use of mineralocorticoid receptor antagonists in patients with obesity to prevent or delay the onset of cardiovascular disease, and establish a foundation for future trials to evaluate incident clinical cardiovascular outcomes.


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	2024	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	5	12/1/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	5	7/28/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $854,614 )
2024	2024	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	001	5	8/6/2024	NON-COMPETING CONTINUATION	$854,614
2024	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	4	3/5/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $854,614

Issue Date FY: 2023 ( Subtotal = $872,054 )
2023	2023	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	001	4	8/11/2023	NON-COMPETING CONTINUATION	$872,054
2023	2022	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	3	6/9/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $872,054

Issue Date FY: 2022 ( Subtotal = $872,054 )
2022	2022	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	001	3	8/18/2022	NON-COMPETING CONTINUATION	$872,054
2022	2021	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	2	8/5/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $872,054

Issue Date FY: 2021 ( Subtotal = $877,015 )
2021	2021	BRIGHAM AND WOMEN'S HOSPITAL, INC., THE	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	001	2	8/13/2021	NON-COMPETING CONTINUATION	$877,015
2021	2020	BRIGHAM AND WOMEN'S HOSPITAL, INC., THE	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	1	8/12/2021	NEW	$0
														Subtotal = $877,015

Issue Date FY: 2020 ( Subtotal = $886,843 )
2020	2020	BRIGHAM AND WOMEN'S HOSPITAL, INC., THE	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Cardiovascular Diseases Research	000	1	9/4/2020	NEW	$886,843
														Subtotal = $886,843

Grand Total All Awards = $4,362,580

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Aldosterone, the Mineralocorticoid Receptor, and Cardiovascular Disease in Obesity

Award Number: R01HL153004

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/15/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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