Study Design
  • HIGHCARE-Andes is a prospective, parallel-group, double-blind, placebo-controlled, randomized trial

  • In total, 100 male and female patients with mild hypertension will be randomised to active treatment (telmisartan 80 mg/nifedipine GITS 30 mg) or placebo (Figure 1)

  • Throughout the study, no other antihypertensive medications will be permitted. Drugs that prevent the occurrence of high altitude symptoms, such as acetazolamide and corticosteroids, are also forbidden

  • In the event of symptoms of acute mountain sickness, an appropriate medical therapy will be allowed based on the decisions of the physicians in charge of study safety procedures
Figure 1. HIGHCARE-Andes study design
Patients
  • The study will include 100 male and female subjects aged 18-65 years who reside at sea level (district of Lima)

  • All patients must have mild hypertension, defined as:

    • Conventional systolic BP 140-159 mmHg or conventional diastolic BP 90-99 mmHg in untreated subjects or after 4 weeks of washout, or

    • Mean 24 h systolic BP 125-140 mmHg or mean 24 ambulatory diastolic BP 80-90 mmHg in untreated subjects or after 4 weeks of washout

  • Exclusion criteria include:

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

    • 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
 
Endpoints
  • The primary endpoint is the difference in 24 h ambulatory systolic BP at high altitude between the telmisartan/nifedipine GITS group and the placebo group

  • Secondary endpoints include:

    • Differences in other ambulatory BP and HR variables (24 h DBP and HR, daytime and night-time BP and HR, nocturnal fall of BP and HR) at high altitude between combination therapy and placebo groups

    • Differences in safety variables (rate of adverse events, Lake Louise Score) between groups

    • Change in ambulatory BP and HR variables (24 h BP and HR, daytime and nighttime BP and HR, nocturnal fall of BP and HR) between sea level and high altitude in each group

    • Change in conventional BP and HR between sea level and high altitude in each group

    • Difference in conventional BP at high altitude between groups

  • Tertiary endpoints include:

    • Differences in other variables assessed in the study at high altitude between treatment groups (polysomnographic data, arterial stiffness, blood tests, echocardiography data)

    • Changes in other variables assessed in the study between sea level condition and high altitude
 
 

Font size minnormalmax

Cardiometabolism
Cardiometabolism