Prevalence of Primary Aldosteronism in Hypertensive Patients Presenting With Atrial Flutter or Fibrillation

NCT01267747 | Completed DMC

• 1 other identifier: GPR-PAPPHY
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 2

Brief Summary

Primary objective of the PAPPHY Study is to establish the prevalence of primary aldosteronism (PA) in consecutive hypertensive patients referred for 'lone' paroxysmal, persistent or permanent atrial flutter or fibrillation (AFF). Design: cohort multicenter prospective study. State-of-the-art criteria and guidelines were followed for case detection and management of both PA and of AF in all enrolled patients (Funder J. J Clin Endocrinol Metab 2008 and 2016; Kirchhof P. Eur Heart J 2011 and 2016).

Conditions

Atrial Fibrillation; Atrial Flutter; Aldosteronism

Keywords

Atrial fibrillation; Atrial Flutter; Primary Aldosteronism; Aldosterone Producing Adenoma

Outcome Measures

Primary Outcomes (1)

• Prevalence of PA in hypertensive patients referred for 'lone' atrial fibrillation.

  Prevalence of PA in hypertensive patients referred for 'lone' paroxysmal, persistent or permanent atrial fibrillation.

  2015-2018

Study Arms (1)

Atrial fibrillation or flutter patients

Patients with 'lone' paroxysmal, persistent, or permanent atrial fibrillation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hypertensive patients presenting with atrial fibrillation or flutter

You may qualify if:

• Unequivocal evidence (by ECG, Holter ECG or medical charts) of AFF (paroxysmal, persistent or permanent) in patients with blood pressure \> 140/90 mmHg on at least 3 office measurements, or current use of anti-hypertensive drugs;
• Written informed consent.

You may not qualify if:

• Patient refusal to participate to the study;
• Moderate-severe valvular or congenital or myocardial heart disease;
• Current abnormal thyroid function;
• Chronic renal failure (sCreatinine \> 200 μM or eGFR \< 40 ml/min, calculated with MDRD formula);
• Hemochromatosis;
• Alcohol abuse;
• Acute coronary syndrome, or history of CABG, PTCA with/without stenting, acute myocardial infarction;
• Hepatitis C virus and/or B and/or HIV infection;
• Pheochromocytoma and other known secondary forms of arterial hypertension;
• Hemodynamic instability precluding withdrawal of drugs (e.g. β-blockers, ARBs, ACE-I, diuretics), interfering with PRA (or DRA) and aldosterone measurements.

Sponsors & Collaborators

• University Hospital Padova: lead

Study Sites (2)

Department of Medicine - DIMED, University of Padova, Italy

Padua, 35128, Italy

Location

Department of Medicine - DIMED, University of Padova, Italy

Padua, Italy

Location

Related Publications (13)

• Beevers DG, Brown JJ, Ferriss JB, Fraser R, Lever AF, Robertson JI, Tree M. Renal abnormalities and vascular complications in primary hyperaldosteronism. Evidence on tertiary hyperaldosteronism. Q J Med. 1976 Jul;45(179):401-10.

  PMID: 948542 BACKGROUND

• Torio-Padron N, Huotari AM, Eisenhardt SU, Borges J, Stark GB. Comparison of pre-adipocyte yield, growth and differentiation characteristics from excised versus aspirated adipose tissue. Cells Tissues Organs. 2010;191(5):365-71. doi: 10.1159/000276594. Epub 2010 Jan 14.

  PMID: 20090305 BACKGROUND

• Carey RM. Primary aldosteronism. Horm Res. 2009 Jan;71 Suppl 1:8-12. doi: 10.1159/000178029. Epub 2009 Jan 21.

  PMID: 19153497 BACKGROUND

• Milliez P, Girerd X, Plouin PF, Blacher J, Safar ME, Mourad JJ. Evidence for an increased rate of cardiovascular events in patients with primary aldosteronism. J Am Coll Cardiol. 2005 Apr 19;45(8):1243-8. doi: 10.1016/j.jacc.2005.01.015.

  PMID: 15837256 BACKGROUND

• Rossi GP, Di Bello V, Ganzaroli C, Sacchetto A, Cesari M, Bertini A, Giorgi D, Scognamiglio R, Mariani M, Pessina AC. Excess aldosterone is associated with alterations of myocardial texture in primary aldosteronism. Hypertension. 2002 Jul;40(1):23-7. doi: 10.1161/01.hyp.0000023182.68420.eb.

  PMID: 12105133 BACKGROUND

• Rossi GP, Sacchetto A, Pavan E, Palatini P, Graniero GR, Canali C, Pessina AC. Remodeling of the left ventricle in primary aldosteronism due to Conn's adenoma. Circulation. 1997 Mar 18;95(6):1471-8. doi: 10.1161/01.cir.95.6.1471.

  PMID: 9118515 BACKGROUND

• Watson T, Karthikeyan VJ, Lip GY, Beevers DG. Atrial fibrillation in primary aldosteronism. J Renin Angiotensin Aldosterone Syst. 2009 Dec;10(4):190-4. doi: 10.1177/1470320309342734. Epub 2009 Jul 17.

  PMID: 19617274 BACKGROUND

• European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery; Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. No abstract available.

  PMID: 20802247 BACKGROUND

• Maiolino G, Rossitto G, Bisogni V, Cesari M, Seccia TM, Plebani M, Rossi GP; PAPY Study Investigators. Quantitative Value of Aldosterone-Renin Ratio for Detection of Aldosterone-Producing Adenoma: The Aldosterone-Renin Ratio for Primary Aldosteronism (AQUARR) Study. J Am Heart Assoc. 2017 May 21;6(5):e005574. doi: 10.1161/JAHA.117.005574.

  PMID: 28529209 BACKGROUND

• 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 BACKGROUND

• Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.

  PMID: 27567408 BACKGROUND

• Funder JW, Carey RM, Fardella C, Gomez-Sanchez CE, Mantero F, Stowasser M, Young WF Jr, Montori VM; Endocrine Society. Case detection, diagnosis, and treatment of patients with primary aldosteronism: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2008 Sep;93(9):3266-81. doi: 10.1210/jc.2008-0104. Epub 2008 Jun 13.

  PMID: 18552288 BACKGROUND

• Seccia TM, Letizia C, Muiesan ML, Lerco S, Cesari M, Bisogni V, Petramala L, Maiolino G, Volpin R, Rossi GP. Atrial fibrillation as presenting sign of primary aldosteronism: results of the Prospective Appraisal on the Prevalence of Primary Aldosteronism in Hypertensive (PAPPHY) Study. J Hypertens. 2020 Feb;38(2):332-339. doi: 10.1097/HJH.0000000000002250.

  PMID: 31834121 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood will be withdrawn to measure levels of ions (sodium, potassium), creatinine, and TSH in the serum, and HbA1c levels, plasma aldosterone concentration (PAC), renin concentrations (DRA) or renin activity (PRA) in the plasma. Urine specimens to measure microalbuminuria. Buffy coat will be stored for downstream gene analysis (next study).

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Hyperaldosteronism; Adrenocortical Adenoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Gian Paolo Rossi, MD, FAHA

  Department of Medicine -DIMED, University Hospital of Padova, Italy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FAHA, FACC

Study Record Dates

• First Submitted: December 27, 2010
• First Posted: December 28, 2010
• Study Start: January 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 7, 2019

Record last verified: 2019-06

Locations

IT (2)