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Trial record 81 of 146 for:    NIFEDIPINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01830530
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : April 12, 2013
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Istituto Auxologico Italiano

Tracking Information
First Submitted Date  ICMJE February 18, 2013
First Posted Date  ICMJE April 12, 2013
Last Update Posted Date April 12, 2013
Study Start Date  ICMJE May 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2013)
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 ]
Difference in 24 h ambulatory systolic BP at high altitude (Visit 4) between combination therapy group and placebo group
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2013)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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). ]
    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 ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 9, 2013)
  • Differences in other variables assessed in the study at high altitude between treatment groups [ Time Frame: high altitude visit ( Visit 4) ]
    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) ]
    Changes in polysomnographic data, arterial stiffness, blood tests, echocardiography data between sea level condition and high altitude
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE HIGH Altitude CArdiovascular REsearch in the ANDES
Official Title  ICMJE HIGH Altitude CArdiovascular REsearch in the ANDES
Brief 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.
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • High Altitude
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2013)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01830530
Other Study ID Numbers  ICMJE 09F102
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Istituto Auxologico Italiano
Study Sponsor  ICMJE Istituto Auxologico Italiano
Collaborators  ICMJE Bayer
Investigators  ICMJE
Principal Investigator: Gianfranco Parati, MD, PhD Istituto Auxologico Italiano
PRS Account Istituto Auxologico Italiano
Verification Date February 2013

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