Clinical Trials Logo

Clinical 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. 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).


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT01267747
Study type Observational
Source University Hospital Padova
Contact
Status Completed
Phase
Start date January 2015
Completion date December 2018

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A