HypertensionPhase 4HIGHCARE-ANCT01830530
HIGH Altitude CArdiovascular REsearch in the ANDES
A Phase 4 study testing Telmisartan and Nifedipine in people with Hypertension and High Altitude, run by Istituto Auxologico Italiano at 1 site in Peru.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, High Altitude
- What is being tested?
- Telmisartan and Nifedipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePeru
- Study dates
- May 2012to Oct 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- to assess the response of BP to high altitude exposure in hypertensive subjects residing at sea level
- 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)
- Conditions
- Hypertension, High Altitude
- Being tested
- Telmisartan, Nifedipine, placebo
- Keywords
- arterial hypertension, high altitude, hypobaric hypoxia, combination treatment, angiotensin receptor blocker, calcium antagonist
- Medical subject headings
- Hypertension, Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
Also called Pritor, Micardis
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
NifedipineDrug
Also called Adalat
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
placeboDrug
two tablets daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan/nifedipine | Experimental | 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 Receives: Drug: Telmisartan; Drug: Nifedipine |
| Placebo | Placebo comparator | Two tablets containing placebo daily in the morning Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 6 weeks of study treatment, during high altitude visit
Secondary outcomes (7)
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
Measured: After 6 weeks of study treatment, during high altitude visit
Lake Louise Score
Differences in Lake Louise Score (score of acute mountain sickness severity) between groups
Measured: After 6 weeks of study treatment, during high altitude visit
Effect of high altitude on ambulatory blood pressure
Change in ambulatory blood pressure between sea level condition and high altitude in both treatment groups
Measured: After 6 weeks of study treatment, during high altitude visit
Effect of high altitude on conventional blood pressure
Change in conventional blood pressure between sea level condition and high altitude in both groups
Measured: After 6 weeks of study treatment, during high altitude visit
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
Measured: After 6 weeks of study treatment, during high altitude visit
Rate of adverse events
Differences in rate of adverse events between groups.
Measured: After 6 weeks of treatment plus up to 1 additional week of treatment needed for high altitude visit (study end).
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
Measured: After 6 weeks of study treatment, during high altitude visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startMay 2012
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Gianfranco Parati, MD, PhD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830530
- Sponsor's protocol ID
- 09F102
- Acronym
- HIGHCARE-A
- Status last verified
- Feb 2013
- First submitted
- 18 Feb 2013
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
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 29886423Bilo 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIGH Altitude CArdiovascular REsearch in the ANDES
- ClinicalTrials.gov ID
- NCT01830530
- Acronym / sponsor ID
- HIGHCARE-A / 09F102
- Conditions
- Hypertension, High Altitude
- Keywords
- arterial hypertension, high altitude, hypobaric hypoxia, combination treatment, angiotensin receptor blocker, calcium antagonist
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- May 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 12 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to assess the response of BP to high altitude exposure in hypertensive subjects residing at sea level
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan/nifedipine | Experimental | Drug: Telmisartan, Drug: NifedipineSubjects treated with telmisartan 80 mg (1 capsule daily in the morning) plus nifedipine slow release 30 mg (1 capsule daily in the morning) combination |
| Placebo | Placebo comparator | Drug: placeboTwo tablets containing placebo daily in the morning |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelmisartanAlso: Pritor, MicardisSubjects 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/nifedipine |
| NifedipineAlso: AdalatSubjects 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/nifedipine |
| placebotwo tablets daily in the morning | Drug | Placebo |
Primary outcome
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
7 secondary outcomes
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
Lake Louise Score
Time frame: After 6 weeks of study treatment, during high altitude visit
Effect of high altitude on ambulatory blood pressure
Time frame: After 6 weeks of study treatment, during high altitude visit
Effect of high altitude on conventional blood pressure
Time frame: After 6 weeks of study treatment, during high altitude visit
Effect of study treatment on conventional blood pressure at high altitude.
Time frame: After 6 weeks of study treatment, during high altitude visit
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).
Effect of study treatment on ambulatory heart rate at high altitude
Time frame: After 6 weeks of study treatment, during high altitude visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2013.
- Derived from this study: PubMed 29886423Caravita 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.
- Derived from this study: PubMed 25895588Bilo 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.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gianfranco Parati, MD, PhD principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telmisartan and Nifedipine in people with Hypertension and High Altitude, run by Istituto Auxologico Italiano at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01830530, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2013.