Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05757076 |
| Other study ID # |
23-132 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2, 2023 |
| Est. completion date |
August 29, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
The Cleveland Clinic |
| Contact |
Kimberly Jenkins, MSNM |
| Phone |
216-445-4791 |
| Email |
jenkink[@]ccf.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The mission of this project is to increase the detection of Primary Aldosteronism (PA), the
most common cause of secondary hypertension, which can either be cured surgically or treated
with targeted medications.
Description:
The mission of this project is to increase the detection of Primary Aldosteronism (PA), the
most common cause of secondary hypertension, which can either be cured surgically or treated
with targeted medications. It is caused by the autonomous secretion of aldosterone by the
adrenal glands.
Hypertension, elevated adrenal aldosterone secretion, and suppressed renin are the hallmarks
of PA. The prevalence of PA varies approximately from 5% up to 20%.
Clinicians continue to erroneously learn that PA is a very rare disorder, thus PA continues
to be under-recognized and undertreated. PA is a major public health issue, and the current
case-detection rate is much below the prevalence rates reported in studies. Correctly
identifying PA in patients will enable effective treatment and potential cure for this
disease Hypertension by itself is a major driver of cardiovascular morbidity and mortality.
There are ~ 1 billion people diagnosed with hypertension in the world, and even if we take a
conservative prevalence of PA of 5% amongst this population, it would yield a staggering
number of 50 million.
Cardiovascular and cerebrovascular morbidity and mortality rates are higher in those with PA
compared to patients with blood pressure-matched essential hypertension.
As per the current Endocrine Society Guidelines, only patients who meet specific clinical
profiles are considered to be candidates for screening for PA. Typically screening involves a
blood test for calculating aldosterone and renin ratio (ARR). An abnormal test indicates the
possibility of PA. It is estimated that only 1% of patients are detected by these screening
guidelines.
Given the underdiagnosed state of this condition, and the high cardiovascular,
cerebrovascular, and renal risks it entails, we should broaden the population to be screened
for PA. All patients with hypertension who are on at least one anti-hypertensive medication
should be screened for PA, especially given the benefits from specific surgical or medical
treatment.
This would help reduce disease burden in a cost-effective manner and will impact the Care of
Patients
