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The PHARAO-Study: Prevention of hypertension in patients with high-normal blood pressure with the ACE-inhibitor ramipril - a randomised prevention trial of the German Hypertension League
Die PHARAO-Studie: Prävention der Hypertonie bei Patienten mit hoch-normalem Blutdruck mit dem ACE-Hemmer Ramipril - eine randomisierte Präventionsstudie der Deutschen Hochdruck Liga
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Published: | August 10, 2005 |
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In previous studies, high-normal (hn) blood pressure (bp) was identified as the main predictor for developing hypertension (hyp), which in turn is the main risk factor for later cardio- and cerebrovascular events. The PHARAO-study was initiated by the German Hypertension League to evaluate the influence of early antihypertensive treatment in patients with hn bp.
The study is conducted according to the PROBE design. Two patient groups are observed. The treatment group receives ramipril (1.25 mg/d with titration to 5.0 mg/d with an option of raising the daily dose to 10 mg if the office bp is still hn after 6 months). No antihypertensive intervention is taken in patients of the comparison group. Both groups are observed for a period of 3 yrs.
Main inclusion criteria are: age > 50 years, no previous antihypertensive therapy and hn bp according to the JNC-VI definition (systolic 130-139 and/or diastolic 85-89 mmHg). Additional ABPM has to show non-hypertensive mean values.
Office bp is checked every six months, ABPM is performed at the beginning and after 12 and 36 months to gain mor data on these specific pats with hn bp.
Primary parameters are the mean values of systolic and diastolic office bp, secondary parameters are the total mortality and the occurance of cardio- and cerebrovascular events. Patients showing hyp in office bp undergo an additional ABPM, so that in contrast to the TROPHY-study white-coat hyp can be unmasked. If a patient develops hyp or cardiovascular disease, he discontinues the study after a final examination.
Also recorded are the incidence and cardio-and cerebrovascular events, the mortality rate and the occurrence of concomitant diseases in patients with hn bp.
Recruitment was finished in Dec. 2002. 1028 pats (514 in each group) have been included.
Study-status will be presented.