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CompletedNCT01830530HIGHCARE-AUpdated Apr 12, 2013

HIGH Altitude CArdiovascular REsearch in the ANDES

A Phase 4 interventional study of Telmisartan and Nifedipine in Hypertension and High Altitude, sponsored by Istituto Auxologico Italiano. Completed at 1 site in Peru. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-04-12.

Sponsored by Istituto Auxologico Italiano · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

This is a parallel group, prospective, double-blind, placebo controlled randomized trial, comparing the effects of combination of two antihypertensive agents (telmisartan/nifedipine)with placebo in hypertensive subjects exposed to high altitude. The principal objectives are:

  1. to assess the response of BP to high altitude exposure in hypertensive subjects residing at sea level
  2. To assess the efficacy and safety of combination of telmisartan 80 mg with nifedipine GITS 30 mg in preventing a possible excessive BP increase in hypertensive subjects exposed to high altitude.

The following data will be collected during the study at the different steps:

  • Clinical history
  • Symptoms and adverse events questionnaire
  • Conventional BP and heart rate (HR) measurement - seated measurements with a validated oscillometric device will be performed after at least 5 minutes rest on non-dominant arm; two measurements will be performed 1-2 minutes apart and their average will be used in the analyses
  • Vital signs:

respiratory rate - will be measured manually over 60 seconds body height and weight, waist circumference blood oxygen saturation (SpO2)

  • Lake Louise Score
  • 24 h ambulatory blood pressure monitoring (ABPM; AND TM2430, AND, Japan)
  • Echocardiography
  • Arterial properties assessment
  • Six minute walking test (6MWT)
  • Cardiopulmonary Exercise Test (CPET) in a subgroup of subjects
  • Polysomnography with a portable device
  • Pulmonary function tests (only at sea level baseline visit)
  • Fluid balance chart
  • Blood and urine analyses: Visit 1: electrolytes, creatinine, estimated glomerular filtration rate (eGFR), glycemia, renin, angiotensin, aldosterone, plasma catecholamines, 24 h urinary sodium excretion, carbonic anhydrase activity and isoenzyme expression (in 50 randomly selected subjects), samples for genetic studies. Visit 2: electrolytes, creatinine, eGFR. Visit 3: complete blood count, electrolytes, creatinine, eGFR, glycemia, insulin, renin, angiotensin, aldosterone, plasma catecholamines, classic urinalysis, microalbuminuria, 24 h urinary sodium excretion, carbonic anhydrase activity and isoenzyme expression (in 50 subjects selected at Visit 1). Visit 4: electrolytes, creatinine, eGFR, glycemia, insulin, renin, angiotensin, aldosterone, plasma catecholamines, 24 h urinary sodium excretion, carbonic anhydrase activity and isoenzyme expression (in 50 subjects selected at Visit 1)
02

Conditions studied

  • Hypertension
  • High Altitude

Keywords

  • arterial hypertension
  • high altitude
  • hypobaric hypoxia
  • combination treatment
  • angiotensin receptor blocker
  • calcium antagonist
03

In context

Altitude Sickness

189 studies on the registry are indexed under Altitude Sickness; 44 are open to participants now.

This study's enrollment of 100 is above the median of 33 across 157 interventional studies indexed under Altitude Sickness.

Browse Altitude Sickness studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Telmisartan/nifedipine

    Subjects treated with telmisartan 80 mg (1 capsule daily in the morning) plus nifedipine slow release 30 mg (1 capsule daily in the morning) combination

    Drug: Telmisartan · Drug: Nifedipine

  • Placebo comparator
    Placebo

    Two tablets containing placebo daily in the morning

    Drug: placebo

Interventions

  • DrugTelmisartan

    Subjects treated with telmisartan 80 mg (1 capsule daily in the morning) plus nifedipine slow release 30 mg (1 capsule daily in the morning) combination

    Also known as: Pritor, Micardis

  • DrugNifedipine

    Subjects treated with telmisartan 80 mg (1 capsule daily in the morning) plus nifedipine slow release 30 mg (1 capsule daily in the morning) combination

    Also known as: Adalat

  • Drugplacebo

    two tablets daily in the morning

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: After 6 weeks of study treatment, during high altitude visit

Secondary outcomes

  1. 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

    Time frame: After 6 weeks of study treatment, during high altitude visit

  2. Lake Louise Score

    Differences in Lake Louise Score (score of acute mountain sickness severity) between groups

    Time frame: After 6 weeks of study treatment, during high altitude visit

  3. Effect of high altitude on ambulatory blood pressure

    Change in ambulatory blood pressure between sea level condition and high altitude in both treatment groups

    Time frame: After 6 weeks of study treatment, during high altitude visit

  4. Effect of high altitude on conventional blood pressure

    Change in conventional blood pressure between sea level condition and high altitude in both groups

    Time frame: After 6 weeks of study treatment, during high altitude visit

  5. 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

    Time frame: After 6 weeks of study treatment, during high altitude visit

  6. Rate of adverse events

    Differences in rate of adverse events between groups.

    Time frame: After 6 weeks of treatment plus up to 1 additional week of treatment needed for high altitude visit (study end).

  7. 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

    Time frame: After 6 weeks of study treatment, during high altitude visit

Other outcomes

  1. 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

    Time frame: high altitude visit ( Visit 4)

  2. blood pressure response at sea level

    Changes in polysomnographic data, arterial stiffness, blood tests, echocardiography data between sea level condition and high altitude

    Time frame: Sea level visit (3) and high altitude visit (4)

07

Study locations

1 site
  • Universidad Peruana Cayetano Heredia
    Lima, Peru
08

References and documents

Publications

  • Caravita S, Faini A, Baratto C, Bilo G, Macarlupu JL, Lang M, Revera M, Lombardi C, Villafuerte FC, Agostoni P, Parati G. Upward Shift and Steepening of the Blood Pressure Response to Exercise in Hypertensive Subjects at High Altitude. J Am Heart Assoc. 2018 Jun 9;7(12):e008506. doi: 10.1161/JAHA.117.008506. PubMed 29886423 ↗
  • Bilo G, Villafuerte FC, Faini A, Anza-Ramirez C, Revera M, Giuliano A, Caravita S, Gregorini F, Lombardi C, Salvioni E, Macarlupu JL, Ossoli D, Landaveri L, Lang M, Agostoni P, Sosa JM, Mancia G, Parati G. Ambulatory blood pressure in untreated and treated hypertensive patients at high altitude: the High Altitude Cardiovascular Research-Andes study. Hypertension. 2015 Jun;65(6):1266-72. doi: 10.1161/HYPERTENSIONAHA.114.05003. Epub 2015 Apr 20. PubMed 25895588 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01830530
Lead sponsor
Istituto Auxologico Italiano
Collaborators
Bayer
Responsible party
Sponsor
First posted
Apr 12, 2013
Start date
May 2012
Primary completion
Sep 2012
Completion
Oct 2012
Last update
Apr 12, 2013

Study contacts

Gianfranco Parati, MD, PhD
principal investigator · Istituto Auxologico Italiano

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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