Prospective Assessment of The Prevalence of Primary Aldosteronism in Hypertensive Patients Presenting With Atrial Flutter or Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- Prevalence of PA in hypertensive patients referred for 'lone' atrial fibrillation.
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Prevalence of PA in hypertensive patients referred for 'lone' atrial fibrillation.
时间窗: 2015-2018
Prevalence of PA in hypertensive patients referred for 'lone' paroxysmal, persistent or permanent atrial fibrillation.
次要结局
未报告次要终点
研究者
Gian Paolo Rossi, MD, FAHA, FACC
MD, FAHA, FACC
University Hospital Padova