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Prospective Phenotyping of Autonomous Aldosterone Secretion

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ClinicalTrials.gov Identifier: NCT03484130
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : September 9, 2020
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Anand Vaidya, Brigham and Women's Hospital

Tracking Information
First Submitted Date March 23, 2018
First Posted Date March 30, 2018
Last Update Posted Date September 9, 2020
Actual Study Start Date June 15, 2018
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2018)
Change in renin [ Time Frame: 5 years ]
The primary outcome is to evaluate the longitudinal change in plasma renin activity
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 6, 2020)
  • SASSI [ Time Frame: 5 years ]
    The longitudinal change in the sodium modulated suppression-to-stimulation index
  • Blood pressure [ Time Frame: 5 years ]
    Longitudinal changes in blood pressure
Original Secondary Outcome Measures
 (submitted: March 29, 2018)
  • SASSI [ Time Frame: 5 years ]
    The longitudinal change in the sodium modulated suppression-to-stimulation index
  • Blood pressure [ Time Frame: 5 years ]
    Longitudinal changes in blood pressure
  • Renal Plasma Flow [ Time Frame: 5 years ]
    Longitudinal changes in renal plasma flow
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Phenotyping of Autonomous Aldosterone Secretion
Official Title Prospective Phenotyping of Autonomous Aldosterone Secretion: A Cohort Study
Brief Summary This prospective cohort study will investigate the physiology and progression of autonomous aldosterone secretion.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Normotensive individuals who have a reasonably high risk of developing hypertension in the next few years
Condition
  • Aldosterone Disorder
  • Adrenal Gland Disease
  • Blood Pressure
Intervention
  • Dietary Supplement: Sodium loaded diet
    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.
  • Dietary Supplement: Restricted sodium diet
    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.
Study Groups/Cohorts 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
Interventions:
  • Dietary Supplement: Sodium loaded diet
  • Dietary Supplement: Restricted sodium diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 29, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2023
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age 35-70 years
  2. Systolic blood pressure of 120-135 mmHg and/or diastolic blood pressure of 75-85 mmHg
  3. 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%
  4. 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
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Anand Vaidya, MD, MMSc 6175258285 anandvaidya@bwh.harvard.edu
Contact: Kathleen Marion, NP 6177325186 kmarion@partners.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03484130
Other Study ID Numbers 2018P000257
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Anand Vaidya, Brigham and Women's Hospital
Study Sponsor Brigham and Women's Hospital
Collaborators National Institutes of Health (NIH)
Investigators
Principal Investigator: Anand Vaidya, MD, MMSc Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date September 2020