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Trial record 97 of 112 for:    EPLERENONE

Prospective Study Assessing Blood Pressure and Other Outcomes Post-treatment in Patients With Primary Aldosteronism (PA_PACES)

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ClinicalTrials.gov Identifier: NCT03174847
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Puar Hai Kiat Troy, Changi General Hospital

Tracking Information
First Submitted Date May 26, 2017
First Posted Date June 5, 2017
Last Update Posted Date August 2, 2019
Actual Study Start Date February 20, 2017
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 31, 2017)
Blood Pressure [ Time Frame: Change from Baseline Blood Pressure at 12 months ]
Blood pressure assessed by 24hr ambulatory BP
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03174847 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 31, 2017)
  • Use of antihypertension medications [ Time Frame: Change from Baseline Antihypertension medications at 12 months ]
    Use of antihypertension medications as expressed in daily defined dosages and total number of medications
  • Blood Pressure [ Time Frame: Change from Baseline Clinic Blood Pressure at 12 months ]
    Clinic blood pressure
  • Cardiac function [ Time Frame: Change from Baseline Cardiac function at 12 months. ]
    Cardiac function using 2DE
  • Left ventricular hypertrophy [ Time Frame: Change from Baseline Left ventricular hypertrophy at 12 months ]
    as assessed by 2DE and ECG
  • Renal Function [ Time Frame: Change from Baseline Renal Function at 12 months ]
    change in serum creatinine, calculated GFR, albuminuria (prevalence and severity)
  • Quality of Life (RAND-36) [ Time Frame: Change from Baseline Quality of Life RAND-36 at 12 months ]
    RAND-36
  • Quality of Life ( Beck's depression inventory II) [ Time Frame: Change from Baseline Quality of Life (BDI-II) at 12 months ]
    Beck's depression inventory II
  • Quality of Life (EQ5D) [ Time Frame: Change from Baseline EQ5D at 12 months ]
    EQ5D
  • Lipids [ Time Frame: Change from Baseline Lipids at 12 months ]
    Lipids
  • Transaminitis [ Time Frame: Change from Baseline transaminitis at 12 months ]
    ALT, AST,
  • Insulin Resistance [ Time Frame: Change from Baseline Insulin resistance at 12 months ]
    Measured with HOMA
  • Fasting glucose [ Time Frame: Change from Baseline Fasting glucose at 12 months ]
    Fasting glucose
  • weight [ Time Frame: Change from Baseline weight at 12 months ]
    change in weight
  • Control of hypertension [ Time Frame: Change from Baseline Status of hypertension control at 12 months ]
    Proportion of patients reaching normal BP (ambulatory /home BP <135/85 or clinic BP <140/90)
  • Cure of Primary aldosteronism [ Time Frame: Change from Baseline Status of primary aldosteronism at 12 months ]
    Proportion of patients with cure of PA after adrenalectomy
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Study Assessing Blood Pressure and Other Outcomes Post-treatment in Patients With Primary Aldosteronism
Official Title Prospective Study Assessing Blood Pressure, Cardiovascular, Endothelial and Other Outcomes poSt-surgical and Medical Treatment in Patients With Primary Aldosteronism
Brief Summary

Majority of patients with hypertension have primary hypertension (without an underlying cause). Secondary hypertension (due to an underlying disease) is important to recognize, as treatment can lead to cure of hypertension. Primary aldosteronism (PA) is the most common cause of secondary hypertension, and can be found in 5-10% of patients locally.

PA is caused by excessive release of a hormone (aldosterone) from the adrenal glands, which can be unilateral (one gland) or bilateral (both glands). Distinction between two is crucial as unilateral disease is treated with the aim of cure by surgery, and bilateral disease is treated by medication.

It has been shown that excess aldosterone has other harmful effects in addition to hypertension, such as directly affecting the heart, blood vessels, kidneys, diabetes and quality of life. This is supported by studies showing reversal of these effects after treatment for PA. In addition, improvements after surgery appears to be superior to medical treatment, although studies have found variable results.

Hence, the investigators aim to accurately subtype patients with PA into unilateral or bilateral disease and study the post-treatment response after both surgery and medicine with regards to the effects on blood pressure, cardiovascular, renal, metabolic and quality of life.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Peripheral blood samples Adrenal vein blood samples (during adrenal vein sampling) Adrenal tissue (post-adrenalectomy)
Sampling Method Probability Sample
Study Population Patients with confirmed primary aldosteronism
Condition
  • Primary Aldosteronism
  • Primary Aldosteronism Due to Aldosterone Producing Adenoma
  • Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Intervention
  • Procedure: Adrenalectomy
    Adrenalectomy for unilateral adrenal hyperplasia / adenoma
  • Drug: Mineralocorticoid Receptor Antagonists
    Medical treatment with MRA / amiloride
    Other Names:
    • Spironolactone
    • Eplerenone
    • Amiloride
Study Groups/Cohorts
  • Medical Treatment
    Patients who undergo medical treatment, in view of bilateral PA, or unilateral PA not keen for surgery, or indeterminate (lack of localisation on tests)
    Intervention: Drug: Mineralocorticoid Receptor Antagonists
  • Surgical Treatment
    Patients with unilateral PA who underwent adrenalectomy
    Intervention: Procedure: Adrenalectomy
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: May 31, 2017)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2020
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

i. Legally capacitated ii. 21-80 years iii. Diagnosed with primary aldosteronism iv. Patient is willing, or has undergone, adrenal surgery (in case of unilateral disease), or medical treatment (if not keen for surgery, medically unfit, or has bilateral disease)

Exclusion Criteria:

i. Unable to give consent ii. < 21 years or > 80 years iii. Glucocorticoid remediable aldosteronism iv. Adrenal Carcinoma v. Severe or terminal medical condition(s) that in the view of the investigator prohibits participation in the study or interferes with possible treatment or health-related quality of life, e.g. cancer, end-stage liver disease, end stage renal failure vi. Female patients who are pregnant, intending to become pregnant or breastfeeding

Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Troy Puar, MRCP(UK) 67888833 troy_puar@cgh.com.sg
Listed Location Countries Singapore
Removed Location Countries  
 
Administrative Information
NCT Number NCT03174847
Other Study ID Numbers PA_PACES
CHF2016.02-P ( Other Grant/Funding Number: Changi Health Fund (Ltd) )
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: No
Responsible Party Puar Hai Kiat Troy, Changi General Hospital
Study Sponsor Changi General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Troy Puar, MRCP (UK) Changi General Hospital
PRS Account Changi General Hospital
Verification Date August 2019