Atrial Fibrillation Clinical Trial
— PAPPHYOfficial title:
Prospective Assessment of The Prevalence of Primary Aldosteronism in Hypertensive Patients Presenting With Atrial Flutter or Fibrillation
NCT number | NCT01267747 |
Other study ID # | GPR-PAPPHY |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | December 2018 |
Verified date | June 2019 |
Source | University Hospital Padova |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 411 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. ß-blockers, ARBs, ACE-I, diuretics), interfering with PRA (or DRA) and aldosterone measurements. |
Country | Name | City | State |
---|---|---|---|
Italy | Department of Medicine - DIMED, University of Padova, Italy | Padova | |
Italy | Department of Medicine - DIMED, University of Padova, Italy | Padova |
Lead Sponsor | Collaborator |
---|---|
University Hospital Padova |
Italy,
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. — View Citation
Carey RM. Primary aldosteronism. Horm Res. 2009 Jan;71 Suppl 1:8-12. doi: 10.1159/000178029. Epub 2009 Jan 21. — View Citation
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. Erratum in: Eur Heart J. 2011 May;32(9):1172. — View Citation
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. — 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 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2. — View Citation
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. — View Citation
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). pii: e005574. doi: 10.1161/JAHA.117.005574. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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