Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01267747
Recruitment Status : Completed
First Posted : December 28, 2010
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Gian Paolo Rossi, MD, FAHA, FACC, University Hospital Padova

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).


Condition or disease
Atrial Fibrillation Atrial Flutter Aldosteronism

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 411 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Assessment of The Prevalence of Primary Aldosteronism in Hypertensive Patients Presenting With Atrial Flutter or Fibrillation
Actual Study Start Date : January 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018


Group/Cohort
Atrial fibrillation or flutter patients
Patients with 'lone' paroxysmal, persistent, or permanent atrial fibrillation



Primary Outcome Measures :
  1. 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.


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Venous blood will be withdrawn to measure levels of ions (sodium, potassium), creatinine, and TSH in the serum, and HbA1c levels, plasma aldosterone concentration (PAC), renin concentrations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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hypertensive patients presenting with atrial fibrillation or flutter
Criteria

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. β-blockers, ARBs, ACE-I, diuretics), interfering with PRA (or DRA) and aldosterone measurements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267747


Locations
Layout table for location information
Italy
Department of Medicine - DIMED, University of Padova, Italy
Padova, Italy, 35128
Department of Medicine - DIMED, University of Padova, Italy
Padova, Italy
Sponsors and Collaborators
University Hospital Padova
Investigators
Layout table for investigator information
Study Director: Gian Paolo Rossi, MD, FAHA Department of Medicine -DIMED, University Hospital of Padova, Italy
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gian Paolo Rossi, MD, FAHA, FACC, MD, FAHA, FACC, University Hospital Padova
ClinicalTrials.gov Identifier: NCT01267747    
Other Study ID Numbers: GPR-PAPPHY
First Posted: December 28, 2010    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Keywords provided by Gian Paolo Rossi, MD, FAHA, FACC, University Hospital Padova:
Atrial fibrillation
Atrial Flutter
Primary Aldosteronism
Aldosterone Producing Adenoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Atrial Flutter
Hyperaldosteronism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases