RecruitingHeart Failure

Unmitigated Aldosterone Signaling During Standard Clinical MRA Dosing

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

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

Sponsor: Yale University

✓ 1. Chronic stable heart failure at optimal volume status. Inclusion will require participants to be NYHA class I or II.
✓ 2. eGFR \> 30 ml/min/1.73m2
✓ 3. Serum potassium ≤5.0 meq/L and ≥3.5 meq/L
✓ 4. Stable heart failure medications without need or expectation for changes during the 8-week study period
✓ 5. Free from heart failure decompensation for the preceding 60 day
✓ 6. Systolic blood pressure \>90 mmHg if not taking an MRA at screening. If patients are already taking an MRA at the time of screening a systolic blood pressure needs to be \>80 mmHg.

✕ 1. Uncontrolled hypertension (SBP \> 160 mmHg)
✕ 2. Severe bladder dysfunction
✕ 3. Current MRA dose \> 50mg spironolactone or equivalent or non MRA potassium sparing diuretic such as amiloride
✕ 4. Contraindication to initiation or withdrawal of spironolactone per study procedures
✕ 5. History of severe hyperkalemia (K\>6.0 meq/l)
✕ 6. Brittle volume sensitive heart failure, recurrent flash pulmonary edema, restrictive cardiomyopathy or other pathology that would make aldosterone infusion high risk
✕ 7. Pregnant or breastfeeding
✕ 8. Women of childbearing potential that are not receiving a highly effective form of contraception. Females of childbearing potential must agree to use a highly effective method of birth control until 14 days after the last dose of study drug. The following are highly effective methods for this study:

New Haven

Source: ClinicalTrials.gov · NCT07281014 · last updated 2026-02-19