Recruiting at 1 site Phase 4 Primary Aldosteronism

Primary Aldosteronism study: Eplerenone

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

ClinicalTrials.gov ID: NCT05030545

What this study is testing

What is Eplerenone?

Eplerenone is an investigational medicine, being studied as a potential treatment for primary aldosteronism.

Also referred to as Inspra, Mineralocorticoid Receptor Antagonist.

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 study wants to find out whether blocking aldosterone improves how well the heart works in patients who produce too much of this hormone.
Who it's for
Adults who have primary aldosteronism, a condition that causes high blood pressure.
What's involved
Participants will take an aldosterone‑blocking medication and undergo heart function tests and other routine check‑ups.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 85

You may be able to join if

  • Cohort A: Overt \& Diagnosed PA
  • 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

You likely can't join if

  • 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 \ 5.1 on labs within the preceding 3 months
  • Adults aged 18-85
  • Able to provide informed consent and willing to comply with the study
See the full eligibility criteria
Who can join
  • Cohort A: Overt \& Diagnosed PA
  • 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
What rules you out
  • 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 \ 5.1 on labs within the preceding 3 months
  • 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
  • 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 \ 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.

The study team makes the final eligibility decision.

Where it is enrolling

  • Boston, Massachusetts, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

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, but 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 to 85 years. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.