NCT07281014 Unmitigated Aldosterone Signaling During Standard Clinical MRA Dosing
| NCT ID | NCT07281014 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Yale University |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-01-27 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2026-01-27 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research study is to understand the biology related to the potential shortcomings of existing anti-aldosterone therapy.
Eligibility Criteria
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
Contact & Investigator
Jeffrey Testani, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT07281014 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07281014 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07281014 currently recruiting?
Yes, NCT07281014 is actively recruiting participants. Contact the research team at veena.s.rao@yale.edu for enrollment information.
Where is the NCT07281014 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT07281014 clinical trial?
NCT07281014 is sponsored by Yale University. The principal investigator is Jeffrey Testani, MD at Yale University. The trial plans to enroll 20 participants.
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