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New treatment option for Heart Failure
Official title Unmitigated Aldosterone Signaling During Standard Clinical MRA Dosing
ClinicalTrials.gov ID: NCT07281014
What this study is testing
What is Spironolactone 25mg?
Spironolactone 25mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research study is to understand the biology related to the potential shortcomings of existing anti-aldosterone therapy.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Chronic stable heart failure at optimal volume status. Inclusion will require participants to be NYHA class I or II.
- eGFR \> 30 ml/min/1.73m2
- Serum potassium ≤5.0 meq/L and ≥3.5 meq/L
- Stable heart failure medications without need or expectation for changes during the 8-week study period
- Free from heart failure decompensation for the preceding 60 day
You likely can't join if
- Uncontrolled hypertension (SBP \> 160 mmHg)
- Severe bladder dysfunction
- Current MRA dose \> 50mg spironolactone or equivalent or non MRA potassium sparing diuretic such as amiloride
- Contraindication to initiation or withdrawal of spironolactone per study procedures
- History of severe hyperkalemia (K\>6.0 meq/l)
- Brittle volume sensitive heart failure, recurrent flash pulmonary edema, restrictive cardiomyopathy or other pathology that would make aldosterone...
See the full eligibility criteria
- Chronic stable heart failure at optimal volume status. Inclusion will require participants to be NYHA class I or II.
- eGFR \> 30 ml/min/1.73m2
- Serum potassium ≤5.0 meq/L and ≥3.5 meq/L
- Stable heart failure medications without need or expectation for changes during the 8-week study period
- Free from heart failure decompensation for the preceding 60 day
- 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.
- Uncontrolled hypertension (SBP \> 160 mmHg)
- Severe bladder dysfunction
- Current MRA dose \> 50mg spironolactone or equivalent or non MRA potassium sparing diuretic such as amiloride
- Contraindication to initiation or withdrawal of spironolactone per study procedures
- History of severe hyperkalemia (K\>6.0 meq/l)
- Brittle volume sensitive heart failure, recurrent flash pulmonary edema, restrictive cardiomyopathy or other pathology that would make aldosterone infusion high risk
- Pregnant or breastfeeding
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.