RecruitingPhase 4NCT07281014

Unmitigated Aldosterone Signaling During Standard Clinical MRA Dosing


Sponsor

Yale University

Enrollment

20 participants

Start Date

Jan 27, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to understand the biology related to the potential shortcomings of existing anti-aldosterone therapy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how well the standard dose of a drug called a mineralocorticoid receptor antagonist (MRA, such as spironolactone) actually blocks a hormone called aldosterone in people with stable chronic heart failure — because there's some evidence the standard dose may not be enough. **You may be eligible if...** - You have stable, chronic heart failure that is well-controlled (NYHA Class I or II) - Your kidney function is above a minimum threshold (eGFR over 30) - Your blood potassium is within the normal range (3.5–5.0 meq/L) - Your heart failure medications have been stable for several months - You have been free from a heart failure flare-up for at least 60 days **You may NOT be eligible if...** - You have uncontrolled high blood pressure (over 160 mmHg) - You have severe bladder problems - You are already on a high dose of spironolactone (over 50 mg) - You have a history of dangerously high potassium levels (over 6.0 meq/L) - You have a particularly unstable or complex form of heart failure - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPlacebo

This study will employ a randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations 1\) IV Vehicle infusion plus oral placebo pill 2) IV Vehicle infusion plus oral 25mg spironolactone 3) IV Aldosterone infusion plus oral placebo pill 4) IV Aldosterone infusion plus oral 25 mg spironolactone on Day 14, 29, 44, 59.

DRUGSpironolactone 25mg

This study will employ a randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations 1\) IV Vehicle infusion plus oral placebo pill 2) IV Vehicle infusion plus oral 25mg spironolactone 3) IV Aldosterone infusion plus oral placebo pill 4) IV Aldosterone infusion plus oral 25 mg spironolactone on Day 14, 29, 44, 59.

DRUGAldosterone

This study will employ a randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations 1\) IV Vehicle infusion plus oral placebo pill 2) IV Vehicle infusion plus oral 25mg spironolactone 3) IV Aldosterone infusion plus oral placebo pill 4) IV Aldosterone infusion plus oral 25 mg spironolactone on Day 14, 29, 44, 59.


Locations(1)

Yale University

New Haven, Connecticut, United States

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NCT07281014


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