Heart failure drug flaw revealed in new study
NCT ID NCT07281014
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times
Summary
This study looks at why standard heart failure medications may not fully block a hormone called aldosterone. Researchers will give 20 adults with stable heart failure either a placebo or the drug spironolactone, then measure how the body handles salt and water. The goal is to understand the biology behind treatment gaps, not to test a new therapy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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21 people
The number who actually took part.
- Started
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Jan 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. Exclusion Criteria: 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: * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal * Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable * Intrauterine device (IUD) * Intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomized partner * Sexual abstinence
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Yale University
New Haven, Connecticut, 06510, United States
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Other studies related to the condition(s) this trial covers.
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