PER-011-12未知未知
HIGH ALTITUDE CARDIOVASCULAR RESEARCH IN THE ANDES
INSTITUTO AUXOLOGICO ITALIANO,0 个研究点目标入组 0 人开始时间: 2012年4月12日最近更新:
试验速览
- 阶段
- 未知
- 发起方
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 65（—）
入选标准
- •1) LOWLANDERS STUDY
- •- MALE AND FEMALE SUBJECTS AGED 18-65 YEARS
- •- PERMANENT RESIDENT AT LOW (<500 M) ALTITUDE
- •- CONVENTIONAL SYSTOLIC BP (AVERAGE OF 2 MEASUREMENTS) 140-159 MMHG OR CONVENTIONAL DIASTOLIC BP 90-99 MMHG IN SUBJECTS UNTREATED OR AFTER 4 WEEKS OF WASHOUT
- •- MEAN DAYTIME SYSTOLIC BP ≥135 AND <150 MMHG AND/OR MEAN DAYTIME DIASTOLIC BP ≥85 AND <95 MMHG IN SUBJECTS UNTREATED OR AFTER 4 WEEKS OF WASHOUT
- •- WRITTEN INFORMED CONSENT TO PARTICIPATE IN THE STUDY.
- •2) HIGHLANDERS STUDY:
- •- MALE AN FEMALE SUBJECTS AGED 18-65 YEARS WITHOUT CARE OF THEIR BLOOD PRESSURE STATUS
- •- WRITTEN INFORMED CONSENT TO PARTICIPATE IN THE STUDY
- •- PERMANENT RESIDENCE AT ALTITUDE ABOVE 4000 M.
排除标准
- •1) LOWLANDERS STUDY
- •- CONVENTIONAL SYSTOLIC BP (AVERAGE OF 2 MEASUREMENTS) ≥150 MMHG AND CONVENTIONAL DIASTOLIC BP ≥95 MMHG IN TREATED SUBJECTS
- •- REGULAR USE OF 2 OR MORE ANTIHYPERTENSIVE DRUGS (WITH THE EXCEPTION OF SUBJECTS ON 2 ANTYHYPERTENSIVE DRUGS IN LOW DOSES)
- •- TREATED ANTIHYPERTENSIVE SUBJECTS IN WHOM WITHDRAWAL OF TREATMENT IS DEEMED UNETHICAL BY THE INVESTIGATOR (EG BECAUSE OF THE EXISTENCE OF COMPELLING INDICATIONS OTHER THAN HYPERTENSION FOR CONTINUOUS USE OF PEVIOUSLY USED ANTIHYPERTENSIVE AGENT)
- •- CONTRAINDICATIONS (INCLUDING A HISTORY OF ADVERSE REACTIONS) TO ANGIOTENSIN RECEPTOR BLOCKERS OR CALCIUM ANTAGONISTS.
- •- HISTORY OF SERIOUS MOUNTAIN SICKNESS
- •- SUBJECTS WHO OVER 3 MONTHS PRECEDING INCLUSION IN THE STUDY SPENT CONSIDERABLE (>1 WEEK) AMOUNT OF TIME AT ALTITUDES ABOVE 2500 M.
- •- CARDIOVASCULAR DISEASES OTHER THAN HYPERTENSION (CORONARY HEART DISEASE, HEART FAILURE, ATRIAL FIBRILLATION, VALVULAR OR CONGENITAL HEART DISEASE, CARDIOMYOPATHIES, CEREBROVASCULAR DISEASE, PERIPHERAL ARTERY DISEASE, AORTIC ANEURYSM)
- •- SUSPECTED OR CONFIRMED SECONDARY HYPERTENSION
- •- DIABETES MELLITUS
- •- SERIOUS RESPIRATORY DISORDERS
- •- OTHER CONDITIONS DEEMED RELEVANT BY THE INVESTIGATOR (INCLUDING LIVER DISEASE, RENAL DISEASE, THYROID DISORDERS)
- •- BMI ≥35 KG/M2
- •- UPPER ARM CIRCUMFERENCE >32 CM
- •- KNOWN SEVERE OBSTRUCTIVE SLEEP APNEA (APNEA-HYPOPNEA INDEX >30 OR USE OF CPAP) OR EXCESSIVE DAYTIME SLEEPINESS (EPWORTH SLEEPINESS SCALE >10)
- •- PREGNANCY
- •- PREMENOPAUSAL WO
研究者
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