Atrial FibrillationPAPPHYNCT01267747
Prevalence of Primary Aldosteronism in Hypertensive Patients Presenting With Atrial Flutter or Fibrillation
An observational study of Atrial Fibrillation and Atrial Flutter, run by University Hospital Padova at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Aldosteronism
- How many people
- 411 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hypertensive patients presenting with atrial fibrillation or flutter
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Department of Medicine - DIMED, University of Padova, Italy
Padova, 35128
Department of Medicine - DIMED, University of Padova, Italy
Padova
About this study
Official title: Prospective Assessment of The Prevalence of Primary Aldosteronism in Hypertensive Patients Presenting With Atrial Flutter or Fibrillation
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).
Read the detailed description
A previous retrospective study documented a 12-fold increase of the risk of AFF in patients with primary aldosteronism (PA) as compared to subjects with primary (essential) hypertension (Milliez 2005). However, being retrospective this investigation could involve a selection bias and therefore is to be regarded as hypothesis-generating rather than a proof-of-concept study.
Hence, based on results of experimental studies, we hypothesize that in a proportion of hypertensive patients presenting with 'lone' PA could be the underlying cause of hypertension leading to AFF. If proven, this hypothesis would imply that an early diagnosis of PA might not only cure PA and hypertension but also prevent AFF in a non negligible number of hypertensive patients.
Primary objective is to establish the prevalence of PA in consecutive hypertensive patients referred for 'lone' paroxysmal, persistent or permanent AFF.
Study design: Prospective multicenter cohort study.
Sample size:
Based on the PAPY study experience and on available data from the literature concerning prevalence studies, we anticipated that the enrolment of at least 1000 consecutive patients will give conclusive evidence on PA prevalence in AFF patients.
Nothwithstanding a long enrolment period (from 2015 to 2018), we were unable to reach the calculated sample size and, therefore, the study was smaller than the size calculated when the PAPPHY study was conceived. In order not to introduce a time-dependent bias associated with an unduly long recruitment with associated changes in practice, it was decided to stop the study upon screening of 411 patients.
Data analysis. Data collection in a specific software, with the database securely stored and analyzed at the core laboratory of the Arterial Hypertension Unit at the University of Padova, Italy.
Experimental Procedures.
Baseline visit
- Clinic evaluation of the patient;
- Collection of demographic data and history;
- Measurement of blood pressure and heart rate;
- Scanning and storage of ECG documenting AFF;
- Echocardiography for measurement of left atrial and aortic diameters, left ventricular thickness and diameters, systolic and diastolic and transmitral Doppler flow velocity indexes;
- Clinical chemistry including serum ions, s-Creatinine, eGFR, HbA1c, microalbuminuria, TSH;
- Measurement of PRA and plasma aldosterone concentration (PAC), under baseline and after captopril challenge, if the patient is not assuming drugs interfering with the renin angiotensin system and eventually after correction of hypokalemia;
- Cardioversion if needed.
Diagnosis of PA in patients with a florid PA phenotype, i.e. a high aldosterone to renin ratio (ARR), e.g. > 100 (in [ng *dl-1 ] * [ng *ml-1 * h-1]) with no further tests, following the Endocrine Society guidelines (Funder J. J Clin Endocrinol Metab 2016) and based on compelling evidence that in these patients the specificity approaches 100%, and the false negative rate 0% (Maiolino G. J Am Heart Assoc 2017).
Exclusion of PA when ARR < 26 and plasma aldosterone concentration (PAC) < 15 ng *dl-1 at the first or a repeated test. In all PA patients presenting with an ARR value in a grey area (i.e. between 26 and 100, and a PAC > 15 ng *dl-1) at the first and a repeated test after further 1 month wash-out, a confirmatory (captopril challenge) test to rule out false positive results (Funder J. J Clin Endocrinol Metab 2016).
At the end of this work-up, computed tomography and adrenal vein sampling in patients with biochemically confirmed PA for PA subtyping.
Diagnosis of aldosterone producing adenoma (APA) confirmed by biochemical cure, e.g. normalization of plasma renin activity (PRA) and aldosterone, after adrenalectomy.
The protocol of the study was revised in 2013 and then in 2015. Herein is reported the last approved version.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Aldosteronism
- Keywords
- Atrial fibrillation, Atrial Flutter, Primary Aldosteronism, Aldosterone Producing Adenoma
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Hyperaldosteronism, Adrenocortical Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation or flutter patients | Patients with 'lone' paroxysmal, persistent, or permanent atrial fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2015-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startJan 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gian Paolo Rossi, MD, FAHA, FACC, University Hospital Padova
- Investigators
- Gian Paolo Rossi, MD, FAHA, Study director, Department of Medicine -DIMED, University Hospital of Padova, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267747
- Sponsor's protocol ID
- GPR-PAPPHY
- Acronym
- PAPPHY
- Status last verified
- Jun 2019
- First submitted
- 27 Dec 2010
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 948542Torio-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.
PubMed 20090305Carey RM. Primary aldosteronism. Horm Res. 2009 Jan;71 Suppl 1:8-12. doi: 10.1159/000178029. Epub 2009 Jan 21.
PubMed 19153497Milliez 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.
PubMed 15837256Rossi 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.
PubMed 12105133Rossi 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.
PubMed 9118515Watson 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.
PubMed 19617274European 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.
PubMed 20802247Maiolino 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.
PubMed 28529209Funder 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.
PubMed 26934393Kirchhof 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.
PubMed 27567408Funder 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.
PubMed 18552288Seccia 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.
PubMed 31834121
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment of The Prevalence of Primary Aldosteronism in Hypertensive Patients Presenting With Atrial Flutter or Fibrillation
- ClinicalTrials.gov ID
- NCT01267747
- Acronym / sponsor ID
- PAPPHY / GPR-PAPPHY
- Conditions
- Atrial Fibrillation, Atrial Flutter, Aldosteronism
- Keywords
- Atrial fibrillation, Atrial Flutter, Primary Aldosteronism, Aldosterone Producing Adenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
A previous retrospective study documented a 12-fold increase of the risk of AFF in patients with primary aldosteronism (PA) as compared to subjects with primary (essential) hypertension (Milliez 2005). However, being retrospective this investigation could involve a selection bias and therefore is to be regarded as hypothesis-generating rather than a proof-of-concept study.
Hence, based on results of experimental studies, we hypothesize that in a proportion of hypertensive patients presenting with 'lone' PA could be the underlying cause of hypertension leading to AFF. If proven, this hypothesis would imply that an early diagnosis of PA might not only cure PA and hypertension but also prevent AFF in a non negligible number of hypertensive patients.
Primary objective is to establish the prevalence of PA in consecutive hypertensive patients referred for 'lone' paroxysmal, persistent or permanent AFF.
Study design: Prospective multicenter cohort study.
Sample size:
Based on the PAPY study experience and on available data from the literature concerning prevalence studies, we anticipated that the enrolment of at least 1000 consecutive patients will give conclusive evidence on PA prevalence in AFF patients.
Nothwithstanding a long enrolment period (from 2015 to 2018), we were unable to reach the calculated sample size and, therefore, the study was smaller than the size calculated when the PAPPHY study was conceived. In order not to introduce a time-dependent bias associated with an unduly long recruitment with associated changes in practice, it was decided to stop the study upon screening of 411 patients.
Data analysis. Data collection in a specific software, with the database securely stored and analyzed at the core laboratory of the Arterial Hypertension Unit at the University of Padova, Italy.
Experimental Procedures.
Baseline visit
- Clinic evaluation of the patient;
- Collection of demographic data and history;
- Measurement of blood pressure and heart rate;
- Scanning and storage of ECG documenting AFF;
- Echocardiography for measurement of left atrial and aortic diameters, left ventricular thickness and diameters, systolic and diastolic and transmitral Doppler flow velocity indexes;
- Clinical chemistry including serum ions, s-Creatinine, eGFR, HbA1c, microalbuminuria, TSH;
- Measurement of PRA and plasma aldosterone concentration (PAC), under baseline and after captopril challenge, if the patient is not assuming drugs interfering with the renin angiotensin system and eventually after correction of hypokalemia;
- Cardioversion if needed.
Diagnosis of PA in patients with a florid PA phenotype, i.e. a high aldosterone to renin ratio (ARR), e.g. > 100 (in [ng *dl-1 ] * [ng *ml-1 * h-1]) with no further tests, following the Endocrine Society guidelines (Funder J. J Clin Endocrinol Metab 2016) and based on compelling evidence that in these patients the specificity approaches 100%, and the false negative rate 0% (Maiolino G. J Am Heart Assoc 2017).
Exclusion of PA when ARR < 26 and plasma aldosterone concentration (PAC) < 15 ng *dl-1 at the first or a repeated test. In all PA patients presenting with an ARR value in a grey area (i.e. between 26 and 100, and a PAC > 15 ng *dl-1) at the first and a repeated test after further 1 month wash-out, a confirmatory (captopril challenge) test to rule out false positive results (Funder J. J Clin Endocrinol Metab 2016).
At the end of this work-up, computed tomography and adrenal vein sampling in patients with biochemically confirmed PA for PA subtyping.
Diagnosis of aldosterone producing adenoma (APA) confirmed by biochemical cure, e.g. normalization of plasma renin activity (PRA) and aldosterone, after adrenalectomy.
The protocol of the study was revised in 2013 and then in 2015. Herein is reported the last approved version.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation or flutter patients | – | –Patients with 'lone' paroxysmal, persistent, or permanent atrial fibrillation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypertensive patients presenting with atrial fibrillation or flutter
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of PA in hypertensive patients referred for 'lone' atrial fibrillation.
Time frame: 2015-2018
Prevalence of PA in hypertensive patients referred for 'lone' paroxysmal, persistent or permanent atrial fibrillation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Background: PubMed 948542Beevers 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.
- Background: PubMed 20090305Torio-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.
- Background: PubMed 19153497Carey RM. Primary aldosteronism. Horm Res. 2009 Jan;71 Suppl 1:8-12. doi: 10.1159/000178029. Epub 2009 Jan 21.
- Background: PubMed 15837256Milliez 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.
- Background: PubMed 12105133Rossi 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.
- Background: PubMed 9118515Rossi 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.
- Background: PubMed 19617274Watson 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.
- Background: PubMed 20802247European 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.
- Background: PubMed 28529209Maiolino 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.
- Background: PubMed 26934393Funder 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.
- Background: PubMed 27567408Kirchhof 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.
- Background: PubMed 18552288Funder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gian Paolo Rossi, MD, FAHA study director
Department of Medicine -DIMED, University Hospital of Padova, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by University Hospital Padova at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of PA in hypertensive patients referred for 'lone' atrial fibrillation. (time frame: 2015-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01267747, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.