HIGH Altitude CArdiovascular REsearch in the ANDES

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is aimed to assess the efficacy of combined treatment with two antihypertensive agents (telmisartan and nifedipine) in subjects with mild hypertension exposed to high altitude.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Auxologico Italiano
• Collaborator: Bayer
• Treatments: Nifedipine; Telmisartan

Criteria

Inclusion Criteria:

• Permanent residence at low (<500 m) altitude

• Conventional systolic BP (average of two 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

Exclusion Criteria:

• Conventional systolic BP (average of two measurements) ≥150 mmHg and conventional diastolic BP ≥95 mmHg in treated subjects

• Regular use of two or more antihypertensive drugs (with the exception of subjects on two antihypertensive drugs in low doses)

• Treated antihypertensive subjects in whom withdrawal of treatment is deemed unethical by the investigator (e.g. because of the existence of compelling indications other than hypertension for continuous use of previously 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 women not using effective contraceptive methods

• Elevated probability of noncompliance with the study procedures