Prospective Study on Primary Aldosteronism in Resistant Hypertension

NCT04213963 | Unknown DMC

• 1 other identifier: The PrePARe Study
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Resistant Hypertension; Primary Aldosteronism; Refractory Hypertension; Hypertensive End-Organ Damage; Atrial Fibrillation; Aortic Ectasia

Keywords

Resistant Hypertension; Primary Aldosteronism; Renin-Angiotensin System; Blood Pressure; Cardiometabolic Risk; Early Atherosclerotic Damage; Oxidative Stress

Outcome Measures

Primary Outcomes (3)

• Number of diagnosis (prevalence) of primary aldosteronism in prospective cohort of patients with resistant hypertension.

  Basal Aldosterone (pg/mL) at baseline.

  Baseline.

• 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.

• 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 Outcomes (18)

• Left ventricular hypertrophy in primary aldosteronism and essential resistant hypertension

  Baseline.

• Microalbuminuria in primary aldosteronism and essential resistant hypertension.

  Baseline.

• Intima media thickness > 0.9 mm rate in primary aldosteronism versus essential resistant hypertension.

  Baseline

• Chronic kidney disease in primary aldosteronism versus essential resistant hypertension.

  Baseline.

• Aortic ectasia in primary aldosteronism versus essential resistant hypertension.

  Baseline.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Division of Endocrinology, Diabetology and Metabolism; University of Turin

Turin, Piedmont, 10126, Italy

RECRUITING

Related Publications (24)

• 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 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.

  PMID: 26934393 RESULT

• 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. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052.

  PMID: 28385310 RESULT

• 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, Mantero F; PAPY Study Investigators. A prospective study of the prevalence of primary aldosteronism in 1,125 hypertensive patients. J Am Coll Cardiol. 2006 Dec 5;48(11):2293-300. doi: 10.1016/j.jacc.2006.07.059. Epub 2006 Nov 13.

  PMID: 17161262 RESULT

• 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 Mar;89(3):1045-50. doi: 10.1210/jc.2003-031337.

  PMID: 15001583 RESULT

• 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. doi: 10.1161/01.hyp.0000040261.30455.b6.

  PMID: 12468575 RESULT

• 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. doi: 10.1038/sj.jhh.1001554.

  PMID: 12756408 RESULT

• 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. doi: 10.1097/00004872-200411000-00026.

  PMID: 15480108 RESULT

• Chandran P. Resistant or difficult-to-control hypertension. N Engl J Med. 2006 Nov 2;355(18):1934; author reply 1934. doi: 10.1056/NEJMc062276. No abstract available.

  PMID: 17079772 RESULT

• Schmidt BM, Schmieder RE. Aldosterone-induced cardiac damage: focus on blood pressure independent effects. Am J Hypertens. 2003 Jan;16(1):80-6. doi: 10.1016/s0895-7061(02)03199-0.

  PMID: 12517689 RESULT

• 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. doi: 10.1210/jc.2005-1733. Epub 2005 Nov 15.

  PMID: 16291704 RESULT

• 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.

  PMID: 18314347 RESULT

• 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.

  PMID: 20226958 RESULT

• Fiebeler A, Luft FC. The mineralocorticoid receptor and oxidative stress. Heart Fail Rev. 2005 Jan;10(1):47-52. doi: 10.1007/s10741-005-2348-y.

  PMID: 15947891 RESULT

• Vogt B, Burnier M. Aldosterone and cardiovascular risk. Curr Hypertens Rep. 2009 Dec;11(6):450-5. doi: 10.1007/s11906-009-0076-8.

  PMID: 19895757 RESULT

• 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. doi: 10.1161/01.ATV.0000152605.64964.c0. Epub 2004 Dec 9.

  PMID: 15591226 RESULT

• Prior RL, Cao G. In vivo total antioxidant capacity: comparison of different analytical methods. Free Radic Biol Med. 1999 Dec;27(11-12):1173-81. doi: 10.1016/s0891-5849(99)00203-8.

  PMID: 10641708 RESULT

• 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.clinbiochem.2008.07.005. Epub 2008 Jul 26.

  PMID: 18692492 RESULT

• 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. doi: 10.1016/j.amjhyper.2007.03.012.

  PMID: 17679033 RESULT

• 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. Epub 2010 Mar 1.

  PMID: 20194710 RESULT

• 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. doi: 10.1016/j.tem.2005.02.003.

  PMID: 15808810 RESULT

• 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 Endocrinol. 2013 Mar 15;168(4):525-32. doi: 10.1530/EJE-12-0912. Print 2013 Apr.

  PMID: 23321497 RESULT

• 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 Atrial Fibrillation in Primary Aldosteronism Patients at Long Term. Hypertension. 2018 Apr;71(4):585-591. doi: 10.1161/HYPERTENSIONAHA.117.10596. Epub 2018 Feb 26.

  PMID: 29483224 RESULT

• 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):1921-6. doi: 10.1016/S0140-6736(08)60834-X.

  PMID: 18539224 RESULT

• 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. Epub 2014 Oct 21.

  PMID: 25336498 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood (5), plasma (1), serum (11) and salivary samples (2) with 24-hour urine collection (1).

MeSH Terms

Conditions

Hyperaldosteronism; Hypertension; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mauro M Maccario, MD

  Endocrinology, Diabetology and Metabolism; University of Turin

  PRINCIPAL INVESTIGATOR

• Ezio E Ghigo, MD

  Endocrinology, Diabetology and Metabolism; University of Turin

  STUDY CHAIR

Central Study Contacts

Mauro M Maccario, MD

CONTACT

00390116709559; mauro.maccario@unito.it

Chiara C Lopez, MD

CONTACT

00390116335544/5527; chiara.lopez@unito.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Professor

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 30, 2019
• Study Start: September 1, 2011
• Primary Completion: September 30, 2020
• Study Completion: October 31, 2025
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)