- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03484130
Prospective Phenotyping of Autonomous Aldosterone Secretion
Prospective Phenotyping of Autonomous Aldosterone Secretion: A Cohort Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Primary aldosteronism is a disorder wherein aldosterone is secreted by the adrenal gland(s) independent of its physiologic regulators and cannot be appropriately suppressed with sodium/volume loading. Primary aldosteronism is a common cause of hypertension and has a relatively high prevalence. This is important since the excessive mineralocorticoid receptor activation in primary aldosteronism contributes to adverse cardiovascular and renal outcomes and death. For these reasons, it is critical that autonomous aldosteronism be detected early in its course since appropriate treatment interventions may prevent cardiovascular disease.
In addition to severe and overt primary aldosteronism in hypertension, human studies have shown that milder forms of primary aldosteronism can exist even among normotensive individuals. Detailed physiologic studies have shown that normotensive individuals with a phenotype of autonomous aldosterone secretion have greater cardiometabolic risk factors, impaired renal-vascular function, and a higher risk for developing incident hypertension. Further, older age is associated with greater autonomous aldosterone secretion, suggesting that autonomous aldosterone secretion may progress over time. A better understanding of the prevalence and progression of this type of "subclinical" autonomous aldosterone secretion may inform our understanding of the pathogenesis of hypertension and cardiometabolic diseases.
This protocol is designed to be a prospective longitudinal study that will carefully characterize the degree of autonomous aldosterone secretion among high-risk normotensive individuals and follow them longitudinally with repeated phenotyping study visits to assess the progression and severity of autonomous aldosterone secretion over time and its relevance to cardiovascular health. Phenotyping visits will include measurements of the renin-angiotensin-aldosterone system under controlled posture and variable sodium intakes and repeated assessments of blood pressure.
This prospective cohort study will provide insights into normal and abnormal aldosterone physiology over time and how it may contribute to time- or age-dependent hypertension and cardiometabolic risk.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anand Vaidya, MD, MMSc
- Phone Number: 6175258285
- Email: anandvaidya@bwh.harvard.edu
Study Contact Backup
- Name: Kathleen Marion, NP
- Phone Number: 6177325186
- Email: kmarion@partners.org
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 35-70 years
- Systolic blood pressure of 120-135 mmHg and/or diastolic blood pressure of 75-85 mmHg
At least one, or more, of the following:
- BMI ≥ 25 kg/m2
- Family history of hypertension prior to the age of 60 years in a parent or sibling
- Diabetes with a hemoglobin A1c < 9%
If systolic blood pressure 115-135 mmHg and/or diastolic blood pressure 70-85 mmHg, must have two or more of the following:
- BMI ≥ 25 kg/m2
- Family history of hypertension prior to the age of 60 years in a parent or sibling
- Diabetes with a hemoglobin A1c < 9%
Exclusion Criteria:
- Known history of hypertension or use of antihypertensive medications
- Known history of stroke, coronary artery disease, myocardial infarction, heart failure, cerebral or aortic aneurysm, or preeclampsia.
- Active cancer that is being treated with chemotherapeutic agents
- Pregnancy
- Breast feeding
- Daily use of prescribed opioid medications
- Illicit drug use (cocaine, heroin, methamphetamine)
- Daily non-steroidal anti-inflammatory medication use
- Daily use of glucocorticoids
- Electrocardiogram that shows evidence of prior myocardial infarction, atrial arrhythmia, left or right bundle branch blocks.
- Estimated glomerular filtration rate < 60 mL/min/1.73m2
- Active and untreated hyper- or hypo-thyroidism
- Abnormal screening laboratories (comprehensive metabolic panel, complete blood count, thyrotropin)
- BMI ≥ 45 kg/m2
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
High-Risk Normotensives
These high-risk normotensives are considered to be enriched for subclinical autonomous aldosterone secretion and have a high risk for developing incident hypertension
|
At baseline, and annually, participants will undergo aldosterone dynamic testing after ~5 days of a sodium loaded diet.
The diet will consist of >180 mmol/day of sodium, ~50 mmol/day of potassium, and 600mg/d of calcium.
At baseline, and annually, participants will undergo aldosterone dynamic testing after ~5 days of a sodium restricted diet.
The diet will consist of <40 mmol/day of sodium, ~50 mmol/day of potassium, and 600mg/d of calcium.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in renin
Time Frame: 5 years
|
The primary outcome is to evaluate the longitudinal change in plasma renin activity
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SASSI
Time Frame: 5 years
|
The longitudinal change in the sodium modulated suppression-to-stimulation index
|
5 years
|
Blood pressure
Time Frame: 5 years
|
Longitudinal changes in blood pressure
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anand Vaidya, MD, MMSc, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P000257
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Blood Pressure
-
SE HealthCentre for Aging and Brain Health InnovationCompletedHypertension | Blood Pressure | Hypotension | High Blood Pressure | Low Blood PressureCanada
-
DongGuk UniversityActive, not recruitingHypertension | Blood Pressure | Ambulatory Blood Pressure | Home Blood Pressure MeasurementKorea, Republic of
-
University of JordanCompletedBlood Pressure | Heart Rate | Airway PressureJordan
-
ROX Medical, Inc.CompletedHypertension | Blood Pressure, High | Blood Pressure, Resistant | Blood Pressure, UncontrolledUnited Kingdom, Netherlands, Belgium
-
Istituto Auxologico ItalianoRecruitingArterial Hypertension | Ambulatory Blood Pressure Monitoring | Blood Pressure Determination | Home Blood Pressure MonitoringItaly
-
RadiRad Co., Ltd.Hualien Tzu Chi General HospitalNot yet recruitingBlood Pressure
-
Riphah International UniversityRecruiting
-
GE HealthcareNot yet recruiting
-
Guangdong Provincial People's HospitalRecruiting
-
Guangdong Provincial People's HospitalRecruiting
Clinical Trials on Sodium loaded diet
-
University of DelawareCompleted
-
University of California, Los AngelesThe California Table grape CommissionCompletedHealthyUnited States
-
Regional Hospital HolstebroCompletedHealthy HumansDenmark
-
Medical College of WisconsinRecruiting
-
University of Sao PauloCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Fundação de Apoio...CompletedHeart Failure; With Decompensation | Heart Failure,CongestiveBrazil
-
Maastricht University Medical CenterCompletedHypertension | Metabolic Syndrome | Insulin Resistance | Abdominal Obesity | Sodium-sensitivityNetherlands
-
DongGuk UniversityBoryung Pharmaceutical Co., LtdCompletedHypertensionKorea, Republic of
-
University of MichiganTerminatedDiastolic Heart Failure | Hypertensive Heart DiseaseUnited States
-
University of VirginiaNational Heart, Lung, and Blood Institute (NHLBI)Unknown
-
University of DelawareCompleted