Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05030545
Recruitment Status : Not yet recruiting
First Posted : September 1, 2021
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Jenifer M. Brown, M.D., Brigham and Women's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Aldosteronism Hypertension Drug: Eplerenone Phase 4

Detailed Description:

The study evaluates the impact of 6 months of treatment with the mineralocorticoid receptor blocking medication eplerenone on the heart's blood flow, using a cardiac PET stress test, and on the heart's structure and function by echocardiogram.

Participants with a confirmed diagnosis of primary aldosteronism will undergo echocardiogram and cardiac PET stress test before and after 6 months of eplerenone treatment.

Participants without a confirmed diagnosis of primary aldosteronism but with hypertension and a recent clinical PET test and echocardiogram will undergo testing to make the diagnosis of primary aldosteronism. Those who test positive will go on to treatment with eplerenone for 6 months, followed by a cardiac PET scan and echocardiogram.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arm Intervention/treatment
Experimental: Eplerenone Treatment
Eplerenone (50-100mg daily, as tolerated by blood pressure and potassium) for 6 months
Drug: Eplerenone
After baseline cardiac imaging with PET and echocardiogram, participants will be treated with eplerenone for 6 months at a starting dose of 50mg daily and up to a maximally tolerated dose of 100mg daily, followed by repeat imaging with PET and echocardiogram.
Other Names:
  • Inspra
  • Mineralocorticoid Receptor Antagonist




Primary Outcome Measures :
  1. Change in myocardial flow reserve (MFR, unitless ratio) [ Time Frame: 6 months ]
    The primary outcome is to evaluate the change in MFR, as measured by PET, pre- vs post-6 months of eplerenone therapy


Secondary Outcome Measures :
  1. Change in peak-stress myocardial blood flow (ml/min/g) [ Time Frame: 6 months ]
    Peak stress myocardial blood flow is measured by PET after vasodilator-induced maximal hyperemia, before and after 6 months of eplerenone treatment

  2. Change in Global Longitudinal Strain (%) [ Time Frame: 6 months ]
    Global Longitudinal Strain is measured by echocardiography before and after 6 months of eplerenone treatment

  3. Change in LV Mass Index (g/m2 of body surface area) [ Time Frame: 6 months ]
    LV Mass Index is measured by echocardiography before and after 6 months of eplerenone treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05030545


Contacts
Layout table for location contacts
Contact: Jenifer M Brown, MD 6177328052 jbrown35@bwh.harvard.edu

Sponsors and Collaborators
Brigham and Women's Hospital
Layout table for additonal information
Responsible Party: Jenifer M. Brown, M.D., Instructor in Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT05030545    
Other Study ID Numbers: 2021P002400
First Posted: September 1, 2021    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Mineralocorticoids
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents
Hormones