HIGH ALTITUDE CARDIOVASCULAR RESEARCH IN THE ANDES
- Registration Number
- PER-011-12
- Lead Sponsor
- INSTITUTO AUXOLOGICO ITALIANO,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method