HIGH Altitude CArdiovascular REsearch in the ANDES (HIGHCARE-A)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT01830530
First received: February 18, 2013
Last updated: April 9, 2013
Last verified: February 2013

February 18, 2013
April 9, 2013
May 2012
September 2012   (final data collection date for primary outcome measure)
Effect of study treatment on 24 h ambulatory systolic blood pressure at high altitude [ Time Frame: After 6 weeks of study treatment, during high altitude visit ] [ Designated as safety issue: No ]
Difference in 24 h ambulatory systolic BP at high altitude (Visit 4) between combination therapy group and placebo group
Same as current
Complete list of historical versions of study NCT01830530 on ClinicalTrials.gov Archive Site
  • Effect of study treatment on ambulatory blood pressure at high altitude (other variables) [ Time Frame: After 6 weeks of study treatment, during high altitude visit ] [ Designated as safety issue: No ]
    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
  • Lake Louise Score [ Time Frame: After 6 weeks of study treatment, during high altitude visit ] [ Designated as safety issue: Yes ]
    Differences in Lake Louise Score (score of acute mountain sickness severity) between groups
  • Effect of high altitude on ambulatory blood pressure [ Time Frame: After 6 weeks of study treatment, during high altitude visit ] [ Designated as safety issue: No ]
    Change in ambulatory blood pressure between sea level condition and high altitude in both treatment groups
  • Effect of high altitude on conventional blood pressure [ Time Frame: After 6 weeks of study treatment, during high altitude visit ] [ Designated as safety issue: No ]
    Change in conventional blood pressure between sea level condition and high altitude in both groups
  • Effect of study treatment on conventional blood pressure at high altitude. [ Time Frame: After 6 weeks of study treatment, during high altitude visit ] [ Designated as safety issue: No ]
    Difference in conventional systolic and diastolic blood pressure at high altitude (Visit 4) between combination therapy group and placebo group
  • Rate of adverse events [ Time Frame: After 6 weeks of treatment plus up to 1 additional week of treatment needed for high altitude visit (study end). ] [ Designated as safety issue: Yes ]
    Differences in rate of adverse events between groups.
  • Effect of study treatment on ambulatory heart rate at high altitude [ Time Frame: After 6 weeks of study treatment, during high altitude visit ] [ Designated as safety issue: No ]
    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
Same as current
  • Differences in other variables assessed in the study at high altitude between treatment groups [ Time Frame: high altitude visit ( Visit 4) ] [ Designated as safety issue: No ]
    Differences between treatment groups in polysomnographic data, arterial stiffness, blood tests, echocardiography data assessed at high altitude
  • blood pressure response at sea level [ Time Frame: Sea level visit (3) and high altitude visit (4) ] [ Designated as safety issue: No ]
    Changes in polysomnographic data, arterial stiffness, blood tests, echocardiography data between sea level condition and high altitude
Same as current
 
HIGH Altitude CArdiovascular REsearch in the ANDES
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.

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)
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hypertension
  • High Altitude
  • Drug: Telmisartan
    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
    Other Names:
    • Pritor
    • Micardis
  • Drug: 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
    Other Name: Adalat
  • Drug: placebo
    two tablets daily in the morning
    Other Name: placebo
  • 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
    Interventions:
    • Drug: Telmisartan
    • Drug: Nifedipine
  • Placebo Comparator: Placebo
    Two tablets containing placebo daily in the morning
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Peru
 
NCT01830530
09F102
No
Istituto Auxologico Italiano
Istituto Auxologico Italiano
Bayer
Principal Investigator: Gianfranco Parati, MD, PhD Istituto Auxologico Italiano
Istituto Auxologico Italiano
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP