Impact of Aldosterone Blockade on Heart Function in Primary Aldosteronism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot clinical study investigates how the hormone aldosterone affects heart function in patients with primary aldosteronism, a condition characterized by excessive aldosterone production leading to hypertension. Participants will receive treatment with eplerenone, a medication that blocks aldosterone, for six months. The study will assess changes in heart blood flow and structure using cardiac PET stress tests and echocardiograms before and after treatment. Both diagnosed and undiagnosed patients with primary aldosteronism will be included in the evaluation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Jenifer M Brown, MD
• Email: jbrown35@bwh.harvard.edu
• Phone: 8573071990

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Spironolactone with antihypertensives for unilateral primary aldosteronism

  This project will try different doses of spironolactone together with usual blood-pressure medicines in adults with lateralized primary aldosteronism who decline surgery to see if it relieves renin suppression and lowers long-term cardiovascular risks.

  Recruiting Third Military Medical University · Chongqing, Chongqing Municipality · NCT07137364

• Screening for Primary Aldosteronism using Steroids

  This study is testing a new steroid-based method to see if it can better identify Primary Aldosteronism in people with high blood pressure who are taking their usual medications.

  Recruiting Chongqing Medical University · Chongqing, Chongqing Municipality · NCT06941116

• Improving screening for primary aldosteronism in patients with hypertension

  This study is testing if giving a small dose of dexamethasone can help doctors better identify primary aldosteronism in patients with high blood pressure who are already on medication.

  Recruiting Medical University of Gdansk · Gdansk, Pomeranian Voivodeship · NCT06740838

• Quantifying sodium levels in muscles of patients with primary aldosteronism

  This study is testing a new way to measure sodium levels in the muscles of people with primary aldosteronism to see if it helps improve understanding and treatment of the condition.

  Recruiting at 2 sites Duke-NUS Graduate Medical School · Singapore and 3 other locations · NCT06569589

• Combining statins with amlodipine to treat primary aldosteronism

  This study is testing if combining statins with amlodipine can help people with primary aldosteronism manage their condition better.

  Recruiting Phase 4 Third Military Medical University · Chongqing, Chongqing Municipality · NCT06523465

• Using low-dose aspirin after preeclampsia to improve recovery

  This study is testing if taking low-dose aspirin for six months after having preeclampsia can help new moms recover better by improving their blood pressure and blood vessel function.

  Recruiting Phase 4 University of Pittsburgh · Pittsburgh, Pennsylvania · NCT06281665

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.