Atrial Fibrillation Clinical Trial
— PrePAReOfficial title:
Prospective Cross-sectional Study on Prevalence of Primary Aldosteronism in Resistant Hypertension and Association With Cardiometabolic Complications
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 31, 2025 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Division of Endocrinology, Diabetology and Metabolism; University of Turin | Torino | Piemonte |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
Italy,
Calhoun DA, Nishizaka MK, Zaman MA, Thakkar RB, Weissmann P. Hyperaldosteronism among black and white subjects with resistant hypertension. Hypertension. 2002 Dec;40(6):892-6. — View Citation
Chandran P. Resistant or difficult-to-control hypertension. N Engl J Med. 2006 Nov 2;355(18):1934; author reply 1934. — View Citation
Douma S, Petidis K, Doumas M, Papaefthimiou P, Triantafyllou A, Kartali N, Papadopoulos N, Vogiatzis K, Zamboulis C. Prevalence of primary hyperaldosteronism in resistant hypertension: a retrospective observational study. Lancet. 2008 Jun 7;371(9628):1921 — View Citation
Eide IK, Torjesen PA, Drolsum A, Babovic A, Lilledahl NP. Low-renin status in therapy-resistant hypertension: a clue to efficient treatment. J Hypertens. 2004 Nov;22(11):2217-26. — View Citation
Fallo F, Della Mea P, Sonino N, Bertello C, Ermani M, Vettor R, Veglio F, Mulatero P. Adiponectin and insulin sensitivity in primary aldosteronism. Am J Hypertens. 2007 Aug;20(8):855-61. — View Citation
Fallo F, Veglio F, Bertello C, Sonino N, Della Mea P, Ermani M, Rabbia F, Federspil G, Mulatero P. Prevalence and characteristics of the metabolic syndrome in primary aldosteronism. J Clin Endocrinol Metab. 2006 Feb;91(2):454-9. Epub 2005 Nov 15. — View Citation
Fiebeler A, Luft FC. The mineralocorticoid receptor and oxidative stress. Heart Fail Rev. 2005 Jan;10(1):47-52. Review. — View Citation
Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 Ma — View Citation
Giacchetti G, Sechi LA, Rilli S, Carey RM. The renin-angiotensin-aldosterone system, glucose metabolism and diabetes. Trends Endocrinol Metab. 2005 Apr;16(3):120-6. Review. — View Citation
Iacobellis G, Petramala L, Cotesta D, Pergolini M, Zinnamosca L, Cianci R, De Toma G, Sciomer S, Letizia C. Adipokines and cardiometabolic profile in primary hyperaldosteronism. J Clin Endocrinol Metab. 2010 May;95(5):2391-8. doi: 10.1210/jc.2009-2204. Ep — View Citation
Lucatello B, Benso A, Tabaro I, Capello E, Caprino MP, Marafetti L, Rossato D, Oleandri SE, Ghigo E, Maccario M. Long-term re-evaluation of primary aldosteronism after medical treatment reveals high proportion of normal mineralocorticoid secretion. Eur J — View Citation
Marzano L, Colussi G, Sechi LA, Catena C. Adrenalectomy is comparable with medical treatment for reduction of left ventricular mass in primary aldosteronism: meta-analysis of long-term studies. Am J Hypertens. 2015 Mar;28(3):312-8. doi: 10.1093/ajh/hpu154 — View Citation
Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol — View Citation
Morrow JD. Quantification of isoprostanes as indices of oxidant stress and the risk of atherosclerosis in humans. Arterioscler Thromb Vasc Biol. 2005 Feb;25(2):279-86. Epub 2004 Dec 9. Review. — View Citation
Mulatero P, Stowasser M, Loh KC, Fardella CE, Gordon RD, Mosso L, Gomez-Sanchez CE, Veglio F, Young WF Jr. Increased diagnosis of primary aldosteronism, including surgically correctable forms, in centers from five continents. J Clin Endocrinol Metab. 2004 — View Citation
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Rossi GP, Bernini G, Caliumi C, Desideri G, Fabris B, Ferri C, Ganzaroli C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Mannelli M, Mattarello MJ, Moretti A, Palumbo G, Parenti G, Porteri E, Semplicini A, Rizzoni D, Rossi E, Boscaro M, Pessina AC, M — View Citation
Rossi GP, Maiolino G, Flego A, Belfiore A, Bernini G, Fabris B, Ferri C, Giacchetti G, Letizia C, Maccario M, Mallamaci F, Muiesan ML, Mannelli M, Negro A, Palumbo G, Parenti G, Rossi E, Mantero F; PAPY Study Investigators. Adrenalectomy Lowers Incident A — View Citation
Rossi GP, Sechi LA, Giacchetti G, Ronconi V, Strazzullo P, Funder JW. Primary aldosteronism: cardiovascular, renal and metabolic implications. Trends Endocrinol Metab. 2008 Apr;19(3):88-90. doi: 10.1016/j.tem.2008.01.006. Epub 2008 Mar 7. Review. — View Citation
Schmidt BM, Schmieder RE. Aldosterone-induced cardiac damage: focus on blood pressure independent effects. Am J Hypertens. 2003 Jan;16(1):80-6. Review. — View Citation
Strauch B, Zelinka T, Hampf M, Bernhardt R, Widimsky J Jr. Prevalence of primary hyperaldosteronism in moderate to severe hypertension in the Central Europe region. J Hum Hypertens. 2003 May;17(5):349-52. — View Citation
Vassalle C, Pratali L, Boni C, Mercuri A, Ndreu R. An oxidative stress score as a combined measure of the pro-oxidant and anti-oxidant counterparts in patients with coronary artery disease. Clin Biochem. 2008 Oct;41(14-15):1162-7. doi: 10.1016/j.clinbioch — View Citation
Vogt B, Burnier M. Aldosterone and cardiovascular risk. Curr Hypertens Rep. 2009 Dec;11(6):450-5. Review. — View Citation
Whaley-Connell A, Johnson MS, Sowers JR. Aldosterone: role in the cardiometabolic syndrome and resistant hypertension. Prog Cardiovasc Dis. 2010 Mar-Apr;52(5):401-9. doi: 10.1016/j.pcad.2009.12.004. Review. — View Citation
* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension. | Basal Aldosterone (pg/mL) at baseline. | Baseline. | |
Primary | Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension. | Basal Plasma Renin Activity (PRA, ng/mL/h) at baseline. | Baseline. | |
Primary | Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension. | Aldosterone (pg/mL) post saline infusion test, performed at baseline. | Baseline. | |
Secondary | Left ventricular hypertrophy in primary aldosteronism and essential resistant hypertension | Left ventricular mass evaluation with Echocardiogram at baseline. | Baseline. | |
Secondary | Microalbuminuria in primary aldosteronism and essential resistant hypertension. | Albuminuria/Creatininuria ratio (mg/mmoL) at baseline. | Baseline. | |
Secondary | Intima media thickness > 0.9 mm rate in primary aldosteronism versus essential resistant hypertension. | Intima media thickness values (mm) evaluation with carotid Doppler ultrasound at baseline. | Baseline | |
Secondary | Chronic kidney disease in primary aldosteronism versus essential resistant hypertension. | Serum creatinine (mg/dL) at baseline. | Baseline. | |
Secondary | Aortic ectasia in primary aldosteronism versus essential resistant hypertension. | Aortic size (mm) determined with echocardiogram at baseline. | Baseline. | |
Secondary | Atrial fibrillation in primary aldosteronism versus essential resistant hypertension. | Electrocardiogram (ECG) at baseline. | Baseline. | |
Secondary | Insulin resistance in primary aldosteronism versus essential resistant hypertension. | Oral glucose tolerance test (OGTT) for determination of glucose (mg/dL) at time 0', 30', 60', 90' and 120' at baseline. | Baseline | |
Secondary | Insulin resistance in primary aldosteronism versus essential resistant hypertension. | Oral glucose tolerance test (OGTT) for determination of insulin (mg/dL) at time 0', 30', 60', 90' and 120' at baseline. | Baseline. | |
Secondary | Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension. | Oral glucose tolerance test (OGTT) for determination of glucose (mg/dL) at time 0' and 120' at baseline. | Baseline. | |
Secondary | Diabetes mellitus rate in primary aldosteronism versus essential resistant hypertension. | HbA1c (mmol/mol) at baseline. | Baseline. | |
Secondary | Sodium levels in primary aldosteronism versus essential resistant hypertension. | Serum Sodium (mmol/L) at baseline. | Baseline. | |
Secondary | Potassium levels in primary aldosteronism versus essential resistant hypertension. | Serum Potassium (mmol/L) at baseline. | Baseline. | |
Secondary | Oxidative stress in primary aldosteronism versus essential resistant hypertension. | Blood determination of 8-isoprostane (UI/L) at baseline. | Baseline. | |
Secondary | Oxidative stress in primary aldosteronism versus essential resistant hypertension. | Blood determination of total antioxidant capacity (UI/L) at baseline. | Baseline. | |
Secondary | Dyslipidemia in primary aldosteronism versus essential resistant hypertension. | Serum triglycerides (mg/dL) at baseline. | Baseline. | |
Secondary | Dyslipidemia in primary aldosteronism versus essential resistant hypertension. | Serum total-Cholesterol (mg/dL) at baseline. | Baseline. | |
Secondary | Dyslipidemia in primary aldosteronism versus essential resistant hypertension. | Serum HDL-Cholesterol (mg/dL) at baseline. | Baseline. | |
Secondary | Dyslipidemia in primary aldosteronism versus essential resistant hypertension. | Serum LDL-Cholesterol (mg/dL) at baseline. | Baseline. |
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