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Prospective Study on Primary Aldosteronism in Resistant Hypertension (PrePARe)

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ClinicalTrials.gov Identifier: NCT04213963
Recruitment Status : Recruiting
First Posted : December 30, 2019
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Mauro Maccario, University of Turin, Italy

Brief Summary:
Prevalence of primary aldosteronism (PA) in resistant hypertension is not clear. In addition, emerging evidence supports the role of elevated serum aldosterone in promoting cardiovascular disease, independently from high blood pressure (BP) levels, but current data on this issue are heterogeneous.

Condition or disease
Resistant Hypertension Primary Aldosteronism Refractory Hypertension Hypertensive End-Organ Damage Atrial Fibrillation Aortic Ectasia

Detailed Description:

PA is the most frequent form of secondary hypertension, with a prevalence that increases with the severity of hypertension. The wide variation of the reported PA prevalence is due to different study design and population. Very few data derive from well designed prospective study. Additional problems in the interpretation of study results are the different diagnostic cut-off used in various centers and the low diffusion of the adrenal vein sampling, that has a central role in the PA diagnosis.

Resistant hypertension (RH) is a condition of insufficient BP control, despite appropriate lifestyle measures and treatment with at least 3 drugs at full dose, including a diuretic, in patients whose adherence to therapy has been confirmed. The primary aim of our study is define prospectively the prevalence of PA in RH.

Moreover, emerging evidence supports the crucial role of elevated serum aldosterone in promoting cardiovascular disease, independently from high BP levels. Aldosterone improves oxidative stress, inflammation, impairs insulin metabolic signaling, reduced endothelial-mediated vasorelaxation and is associated to cardiovascular and renal abnormalities. However, current data on the contribution of PA on cardiometabolic complications have heterogeneous results.

The secondary outcome of our study is to investigate prospectively the association of PA with cardiometabolic complications in a cohort of patients with RH.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cross-sectional Study on Prevalence of Primary Aldosteronism in Resistant Hypertension and Association With Cardiometabolic Complications
Actual Study Start Date : September 1, 2011
Actual Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 31, 2025





Primary Outcome Measures :
  1. Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension. [ Time Frame: Baseline. ]
    Basal Aldosterone (pg/mL) at baseline.

  2. Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension. [ Time Frame: Baseline. ]
    Basal Plasma Renin Activity (PRA, ng/mL/h) at baseline.

  3. Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension. [ Time Frame: Baseline. ]
    Aldosterone (pg/mL) post saline infusion test, performed at baseline.


Secondary Outcome Measures :
  1. Left ventricular hypertrophy in primary aldosteronism and essential resistant hypertension [ Time Frame: Baseline. ]
    Left ventricular mass evaluation with Echocardiogram at baseline.

  2. Microalbuminuria in primary aldosteronism and essential resistant hypertension. [ Time Frame: Baseline. ]
    Albuminuria/Creatininuria ratio (mg/mmoL) at baseline.

  3. Intima media thickness > 0.9 mm rate in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline ]
    Intima media thickness values (mm) evaluation with carotid Doppler ultrasound at baseline.

  4. Chronic kidney disease in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    Serum creatinine (mg/dL) at baseline.

  5. Aortic ectasia in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    Aortic size (mm) determined with echocardiogram at baseline.

  6. Atrial fibrillation in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    Electrocardiogram (ECG) at baseline.

  7. Insulin resistance in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline ]
    Oral glucose tolerance test (OGTT) for determination of glucose (mg/dL) at time 0', 30', 60', 90' and 120' at baseline.

  8. Insulin resistance in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    Oral glucose tolerance test (OGTT) for determination of insulin (mg/dL) at time 0', 30', 60', 90' and 120' at baseline.

  9. Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    Oral glucose tolerance test (OGTT) for determination of glucose (mg/dL) at time 0' and 120' at baseline.

  10. Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    HbA1c (mmol/mol) at baseline.

  11. Sodium levels in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    Serum Sodium (mmol/L) at baseline.

  12. Potassium levels in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    Serum Potassium (mmol/L) at baseline.

  13. Oxidative stress in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    Blood determination of 8-isoprostane (UI/L) at baseline.

  14. Oxidative stress in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    Blood determination of total antioxidant capacity (UI/L) at baseline.

  15. Dyslipidemia in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    Serum triglycerides (mg/dL) at baseline.

  16. Dyslipidemia in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    Serum total-Cholesterol (mg/dL) at baseline.

  17. Dyslipidemia in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    Serum HDL-Cholesterol (mg/dL) at baseline.

  18. Dyslipidemia in primary aldosteronism versus essential resistant hypertension. [ Time Frame: Baseline. ]
    Serum LDL-Cholesterol (mg/dL) at baseline.


Biospecimen Retention:   Samples Without DNA
Whole blood (5), plasma (1), serum (11) and salivary samples (2) with 24-hour urine collection (1).


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
At least 100 consecutive patients with age over 18 and under 80 years old and resistant hypertension (defined as uncontrolled blood pressure despite the use of at least 3 antihypertensive drugs at full dose, including a diuretic) referred to the center for diagnosis and treatment of Hypertension (Division of Endocrinology, Diabetology and Metabolism, University of Turin) between March 2011 and July 2020.
Criteria

Inclusion Criteria:

  • age over 18 and under 80 years old;
  • diagnosis of resistant hypertension defined as: uncontrolled blood pressure at ambulatory blood pressure measurement (ABPM), despite the use of at least 3 antihypertensive drugs at full dose, including a diuretic.

Exclusion Criteria:

  • age under 18 or over 80 years old;
  • pseudo-resistant hypertension (poor medication adherence, high salt intake);
  • previous cardiovascular disease;
  • insulin treated diabetes mellitus;
  • other than primary aldosteronism cause of secondary hypertension (obstructive sleep apnea, renal artery stenosis, pheochromocytoma/paraganglioma, primary hyperparathyroidism, autonomous cortisol secretion or over hypercortisolism);
  • liver cirrhosis;
  • chronic heart failure;
  • known malignant neoplasm;
  • chronic disease with major organ involvement;
  • excessive alcohol ingestion;
  • current steroids assumption;
  • use of sympathomimetic drugs;
  • use of contraceptives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213963


Contacts
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Contact: Mauro M Maccario, MD 00390116709559 mauro.maccario@unito.it
Contact: Chiara C Lopez, MD 00390116335544/5527 chiara.lopez@unito.it

Locations
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Italy
Division of Endocrinology, Diabetology and Metabolism; University of Turin Recruiting
Torino, Piemonte, Italy, 10126
Contact: Mauro M Maccario, MD    00390116709559    mauro.maccario@unito.it   
Contact: Mirko M Parasiliti Caprino, MD, PhD    00390116335544/5527    mirko.parasiliticaprino@unito.it   
Principal Investigator: Mauro M Maccario, MD         
Sub-Investigator: Mirko M Parasiliti Caprino, MD, PhD         
Sub-Investigator: Chiara C Lopez, MD         
Sub-Investigator: Ezio E Ghigo, MD         
Sub-Investigator: Nunzia N Prencipe, MD         
Sub-Investigator: Andrea A Benso, MD, PhD         
Sub-Investigator: Martina M Bollati, MD         
Sub-Investigator: Filippo F Egalini, MD         
Sponsors and Collaborators
University of Turin, Italy
Investigators
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Principal Investigator: Mauro M Maccario, MD Endocrinology, Diabetology and Metabolism; University of Turin
Study Chair: Ezio E Ghigo, MD Endocrinology, Diabetology and Metabolism; University of Turin
Publications of Results:

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Responsible Party: Mauro Maccario, Medical Doctor, Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT04213963    
Other Study ID Numbers: The PrePARe Study
First Posted: December 30, 2019    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mauro Maccario, University of Turin, Italy:
Resistant Hypertension
Primary Aldosteronism
Renin-Angiotensin System
Blood Pressure
Cardiometabolic Risk
Early Atherosclerotic Damage
Oxidative Stress
Additional relevant MeSH terms:
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Hypertension
Atrial Fibrillation
Hyperaldosteronism
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases