RightFit
RecruitingPhase 4

Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Those who test positive will go on to treatment with eplerenone for 6 months, followed by a cardiac PET scan and echocardiogram."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether medicine that blocks the hormone aldosterone can help the heart work better. It is for adults with high blood pressure who have diagnosed primary aldosteronism (too much aldosterone) or may have a mild, undiagnosed form.

This research study aims to learn more about the impact the hormone aldosterone on the heart. Primary aldosteronism is a condition where the body's adrenal glands make too much of the hormone aldosterone, which can cause high blood pressure and increase the risk of heart and kidney disease. Treatment with medications that block aldosterone can reduce that risk. This study is trying to learn whether treatment with a medication that blocks aldosterone can improve heart function in people who make too much aldosterone.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–85 years old.
  • Be able to agree to join after learning about the study and willing to follow study instructions.
  • Fit safely in the PET/CT scanner: weight limit 500 pounds, opening 70 cm across and 220 cm around.
  • Take at least one medicine for high blood pressure.
  • Group A: Have confirmed primary aldosteronism and not yet be treated with medicines that block aldosterone.
  • Group B: Have had a medically needed heart PET blood-flow scan within 3 months and an echocardiogram (heart ultrasound) within 6 months.

Who can't join

  • Past heart attack, heart bypass surgery, or heart transplant.
  • Known heart muscle disease with a pumping strength below 40%, thickened heart muscle, or amyloid protein buildup.
  • An allergy or other medical reason you cannot take eplerenone or spironolactone.
  • Pregnant or breastfeeding.
  • Blood tests within 3 months showing kidney function (eGFR) below 45 or potassium above 5.1.
  • Group A: Plan to have an adrenal gland removed within 6 months.
  • Group B: The qualifying PET scan shows reduced blood flow in 10% or more of the heart.
  • Group B: Plan within 6 months to have a heart artery dye test or a procedure to restore blood flow to the heart.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Cohort A: Overt \& Diagnosed PA Inclusion Criteria: * Adults aged 18-85 * Able to provide informed consent and willing to comply with the study * Able to fit safely in PET/CT scanner (weight limit 500 pounds; diameter and circumference of PET/CT scanner are 70 cm and 220 cm, respectively) * Hypertension treated with at least one antihypertensive drug * Cohort A: Clinically confirmed diagnosis of PA not yet treated with mineralocorticoid receptor antagonists Exclusion Criteria: * History of MI, CABG, known cardiomyopathy (EF \<40%, hypertrophic cardiomyopathy, and/or amyloid), cardiac transplantation * Contraindication or allergy to eplerenone or spironolactone * Current pregnancy or breastfeeding * eGFR \< 45 mL/min/1.73m2 or potassium \> 5.1 on labs within the preceding 3 months * Cohort A: Planned adrenalectomy in the subsequent 6 months Cohort B: Subclinical \& Undiagnosed PA Inclusion Criteria: * Adults aged 18-85 * Able to provide informed consent and willing to comply with the study * Able to fit safely in PET/CT scanner (weight limit 500 pounds; diameter and circumference of PET/CT scanner are 70 cm and 220 cm, respectively) * Hypertension treated with at least one antihypertensive drug * Cohort B: Clinically indicated cardiac PET perfusion scan within the preceding 3 months and echocardiogram within the preceding 6 months Exclusion Criteria: * History of MI, CABG, known cardiomyopathy (EF \<40%, hypertrophic cardiomyopathy, and/or amyloid), cardiac transplantation * Contraindication or allergy to eplerenone or spironolactone * Current pregnancy or breastfeeding * eGFR \< 45 mL/min/1.73m2 or potassium \> 5.1 on labs within the preceding 3 months * Cohort B: 10% or greater burden of ischemia on qualifying PET * Cohort B: Planned coronary angiogram/revascularization in the subsequent 6 months.

Study sites (1)

MA