EARLY Treatment with azilsartan compared to ACE-inhibitors in anti-hypertensive therapy – rationale and design of the EARLY hypertension registry

Table 2 Variables documented at baseline, and at 6 and 12 months of follow-up

	Baseline	6 months FU	12 months FU
Socio-demographic variables ¹	X	X⁹	X⁹
Blood pressure / heart rate	X	X	X
Anamnestic concomitant disease ²	X
Risk factors ³	X
Anti-hypertensive treatment incl. dose	X	X	X
Further pharmacotherapy ⁴	X	X	X
Further investigations ⁵	X
Laboratory values ⁶	X	X	X
ABPM ⁷ (subgroup)	X	X	X
Event rate (lethal / non-lethal)		X	X
Incident concomitant disease ⁸		X	X
Adverse events		X	X

Legend:
1) age, gender, height, weight, body mass index (computed).
2) heart failure (including NYHA class), coronary artery disease, stroke / transitory ischemic attack, atrial fibrillation, peripheral arterial disease, diabetes mellitus (including duration), kidney disease (including glomerular filtration rate <60 ml/1.73m², dialysis or transplantation), malignancy, chronic obstructive pulmonary disease, depression and other severe diseases.
3) hypercholesterolemia, hyperlipidemia, smoking (present, past or never, including duration).
4) other than antihypertensive drugs: nitrates, platelet aggregation inhibitors, oral anticoagulants, statins or antidepressive drugs.
5) signs of left ventricular hypertrophy (ECG or Echo), intima / media thickness > 0.9 mm or plaque, ankle-brachial index (ABI) < 0.9, pulse wave velocity > 12 ms, microalbuminuria.
6) hemoglobin, glucose, bA1c, creatinine, sodium, potassium, calcium, phosphate, total cholesterol, LDL-C, HDL-C, triglycerides, C-reactive protein, uric acid, urinary albumin concentration and albumin to creatinine ratio (all if available within three months prior to visit.
7) mean blood pressure and heart rate during daytime, nighttime and 24-hour average.
8) corresponding to 2) including whether patients were hospitalized and for how long.
9) weight only.

ISSN: 1471-2261