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

Primary Purpose

Primary Aldosteronism, Hypertension

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Eplerenone
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Aldosteronism

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Eplerenone Treatment

Arm Description

Eplerenone (50-100mg daily, as tolerated by blood pressure and potassium) for 6 months

Outcomes

Primary Outcome Measures

Change in myocardial flow reserve (MFR, unitless ratio)
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

Change in peak-stress myocardial blood flow (ml/min/g)
Peak stress myocardial blood flow is measured by PET after vasodilator-induced maximal hyperemia, before and after 6 months of eplerenone treatment
Change in Global Longitudinal Strain (%)
Global Longitudinal Strain is measured by echocardiography before and after 6 months of eplerenone treatment
Change in LV Mass Index (g/m2 of body surface area)
LV Mass Index is measured by echocardiography before and after 6 months of eplerenone treatment

Full Information

First Posted
August 26, 2021
Last Updated
February 24, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05030545
Brief Title
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Official Title
Cardiovascular Manifestations of MR Activation in Primary Aldosteronism: Pilot Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
October 31, 2026 (Anticipated)
Study Completion Date
February 28, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Aldosteronism, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eplerenone Treatment
Arm Type
Experimental
Arm Description
Eplerenone (50-100mg daily, as tolerated by blood pressure and potassium) for 6 months
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Other Intervention Name(s)
Inspra, Mineralocorticoid Receptor Antagonist
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in myocardial flow reserve (MFR, unitless ratio)
Description
The primary outcome is to evaluate the change in MFR, as measured by PET, pre- vs post-6 months of eplerenone therapy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in peak-stress myocardial blood flow (ml/min/g)
Description
Peak stress myocardial blood flow is measured by PET after vasodilator-induced maximal hyperemia, before and after 6 months of eplerenone treatment
Time Frame
6 months
Title
Change in Global Longitudinal Strain (%)
Description
Global Longitudinal Strain is measured by echocardiography before and after 6 months of eplerenone treatment
Time Frame
6 months
Title
Change in LV Mass Index (g/m2 of body surface area)
Description
LV Mass Index is measured by echocardiography before and after 6 months of eplerenone treatment
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenifer M Brown, MD
Phone
8573071990
Email
jbrown35@bwh.harvard.edu
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Abel
Phone
617-525-3803

12. IPD Sharing Statement

Plan to Share IPD
No

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

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