Cardiovascular Manifestations of MR Activation in Primary... | NCT05030545

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

NCT05030545

Sponsor

Brigham and Women's Hospital

Status

Recruiting

Last Update Posted

Feb 7, 2025Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

Primary Aldosteronism
Hypertension

Interventions

Eplerenone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2022Actual

Primary Completion Date

Oct 31, 2026Estimated

Completion Date

Feb 28, 2027Estimated

First Submitted Date

Aug 26, 2021

First Submission Date that Met QC Criteria

Aug 26, 2021

First Posted Date

Sep 1, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2025

Last Update Posted Date

Feb 7, 2025Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eplerenone Treatment	Experimental	Eplerenone (50-100mg daily, as tolerated by blood pressure and potassium) for 6 months	Drug: Eplerenone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Eplerenone	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	6 months

Secondary Outcomes

Measure	Description	Time Frame
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	6 months
Change in Global Longitudinal Strain (%)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006929	Hyperaldosteronism
D006973	Hypertension

ID	Term
D000308	Adrenocortical Hyperfunction
D000307	Adrenal Gland Diseases
D004700	Endocrine System Diseases
D014652	Vascular Diseases

ID	Term
D000077545	Eplerenone
D000451	Mineralocorticoid Receptor Antagonists

ID	Term
D007783	Lactones
D009930	Organic Chemicals
D011283	Pregnenes
D011278	Pregnanes
D013256