Hypertension Clinical Trial
— HIGHCARE-AOfficial title:
HIGH Altitude CArdiovascular REsearch in the ANDES
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Peru | Universidad Peruana Cayetano Heredia | Lima |
Lead Sponsor | Collaborator |
---|---|
Istituto Auxologico Italiano | Bayer |
Peru,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Differences in other variables assessed in the study at high altitude between treatment groups | Differences between treatment groups in polysomnographic data, arterial stiffness, blood tests, echocardiography data assessed at high altitude | high altitude visit ( Visit 4) | No |
Other | blood pressure response at sea level | Changes in polysomnographic data, arterial stiffness, blood tests, echocardiography data between sea level condition and high altitude | Sea level visit (3) and high altitude visit (4) | No |
Primary | Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude | Difference in 24 h ambulatory systolic BP at high altitude (Visit 4) between combination therapy group and placebo group | After 6 weeks of study treatment, during high altitude visit | No |
Secondary | Effect of study treatment on ambulatory blood pressure at high altitude (other variables) | Differences in other ambulatory blood pressure (BP) variables (including 24 h diastolic BP, daytime and night-time BP, nocturnal fall of BP) at high altitude (V4) between combination therapy and placebo groups | After 6 weeks of study treatment, during high altitude visit | No |
Secondary | Lake Louise Score | Differences in Lake Louise Score (score of acute mountain sickness severity) between groups | After 6 weeks of study treatment, during high altitude visit | Yes |
Secondary | Effect of high altitude on ambulatory blood pressure | Change in ambulatory blood pressure between sea level condition and high altitude in both treatment groups | After 6 weeks of study treatment, during high altitude visit | No |
Secondary | Effect of high altitude on conventional blood pressure | Change in conventional blood pressure between sea level condition and high altitude in both groups | After 6 weeks of study treatment, during high altitude visit | No |
Secondary | Effect of study treatment on conventional blood pressure at high altitude. | Difference in conventional systolic and diastolic blood pressure at high altitude (Visit 4) between combination therapy group and placebo group | After 6 weeks of study treatment, during high altitude visit | No |
Secondary | Rate of adverse events | Differences in rate of adverse events between groups. | After 6 weeks of treatment plus up to 1 additional week of treatment needed for high altitude visit (study end). | Yes |
Secondary | Effect of study treatment on ambulatory heart rate at high altitude | Differences in ambulatory heart rate (HR) variables (including 24 h, daytime and night-time HR, and nocturnal fall of HR) at high altitude (V4) between combination therapy and placebo groups | After 6 weeks of study treatment, during high altitude visit | No |
Status | Clinical Trial | Phase | |
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