NL-OMON44513已完成不适用
A randomized, placebo-controlled, double blind, 4-period, cross-over trial, to study blood pressure lowering effects of losartan, Moxonidine and Low sodium diet in former pre-eclamptic women - PALM study
niversitair Medisch Centrum Utrecht0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patient is a female between 18 and 45 years of age on the day of signing informed consent.
- •2. Have a recent history of preeclampsia that is defined as gestational hypertension and concomitant proteinuria in the second half of pregnancy. Gestational hypertension was defined according to the criteria of the International Society for the Study of Hypertension in Pregnancy (ISSHP) as diastolic blood pressure above 90 mmHg and/or systolic blood pressure above 140 mmHg, measured on two or more separate occasions at least 4 hours apart. Proteinuria was diagnosed with urinary protein was above 300 mg per 24 hour or above 2+ at dipstick urinalysis 17
- •3. All patients should fulfil the following diagnostic criterion:
- •- Off treatment SBP > 120 mmHg and/or DBP > 80 mmHg during both visits.
- •4. Blood pressure is assessed by office readings in accordance with current guidelines for hypertension diagnosis18. The patient needs to be seated some minutes before and during the measurement. The cuff size should be adjusted to the patients* arm circumference and needs to be on the same height level as the patients* sternum during the measurements. Blood pressure is determined to a 2-mmHg accuracy-level. Blood pressure is measured on both arms during the first visit. If both measurements differ more than 10 mmHg, the highest value is taken. After at least 15 seconds, the measurement is repeated during the same visit. The highest mean of the two measurements on the same arm is considered as the actual blood pressure value.
- •5. Patient understands the study procedures, alternative treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
排除标准
- •1. SBP >180 mmHg and/or DBP >110 mmHg during one or more screening measurements.
- •2. Current pregnancy
- •3. Use of *recreational* or illicit drugs
- •4. Recent history (within the last year) of alcohol abuse or dependence.
- •5. Several medical conditions as depicted in the protocol
研究者
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