HIGH Altitude CArdiovascular REsearch in the ANDES

NCT01830530 | Completed Phase 4

• 1 other identifier: 09F102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; High Altitude

Keywords

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

Outcome Measures

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

  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)

  After 6 weeks of study treatment, during high altitude visit

• Lake Louise Score

  After 6 weeks of study treatment, during high altitude visit

• Effect of high altitude on ambulatory blood pressure

  After 6 weeks of study treatment, during high altitude visit

• Effect of high altitude on conventional blood pressure

  After 6 weeks of study treatment, during high altitude visit

• Effect of study treatment on conventional blood pressure at high altitude.

  After 6 weeks of study treatment, during high altitude visit

Other Outcomes (2)

• Differences in other variables assessed in the study at high altitude between treatment groups

  high altitude visit ( Visit 4)

• blood pressure response at sea level

  Sea level visit (3) and high altitude visit (4)

Study Arms (2)

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

Drug: Telmisartan; Drug: Nifedipine

Placebo

PLACEBO COMPARATOR

Two tablets containing placebo daily in the morning

Drug: placebo

Interventions

Telmisartan DRUG

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

Telmisartan/nifedipine

Nifedipine DRUG

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

Telmisartan/nifedipine

placebo DRUG

two tablets daily in the morning

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead
• Bayer: collaborator

Study Sites (1)

Universidad Peruana Cayetano Heredia

Lima, Peru

Location

Related Publications (2)

• 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.

  PMID: 29886423 DERIVED

• 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.

  PMID: 25895588 DERIVED

MeSH Terms

Conditions

Hypertension; Altitude Sickness

Interventions

Telmisartan; Nifedipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Gianfranco Parati, MD, PhD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: April 12, 2013
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 12, 2013

Record last verified: 2013-02

Locations

PE (1)