Effects of Nebivolol Versus Carvedilol on Cardiopulmonary Function at High Altitude in Healthy Subjects.

This study has been completed.
Sponsor:
Collaborator:
Menarini Group
Information provided by:
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT00924833
First received: February 19, 2009
Last updated: September 1, 2009
Last verified: February 2009
  Purpose

Exposure of healthy subjects to high altitude hypoxia elicits changes in cardiovascular, respiratory and metabolic features as weel as in exercise performance similar, for some aspects, to those observed in chronic heart failure. Exposure to high altitude hypoxia represents a suitable model to assess different treatments proposed for this pathological condition. Our aim was to evaluate the impact of two different third-generation beta-blockers used in heart failure (carvedilol and nebivolol) on cardiovascular, respiratory, metabolic profile and on exercise performance at high altitude.


Condition Intervention Phase
Hypoxia
Altitude
Heart Failure
Drug: placebo
Drug: Carvedilol
Drug: Nebivolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Cardiovascular, Metabolic and Respiratory Effects of Nebivolol and Carvedilol at High Altitude in Healthy Subjects.

Resource links provided by NLM:


Further study details as provided by Istituto Auxologico Italiano:

Primary Outcome Measures:
  • Peak Exercise Oxygen Consumption [ Time Frame: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment. ] [ Designated as safety issue: No ]
  • Delta Peak Exercise Oxygen Consumption Time 1 Versus Time 3 [ Time Frame: Time 1: sea level, baseline, no treatment. Time 3: within the first two days of high altitude exposure, under treatment. ] [ Designated as safety issue: No ]
  • Peak Exercise Minute Ventilation [ Time Frame: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment. ] [ Designated as safety issue: No ]
  • Delta Peak Exercise Minute Ventilation Time 1 Versus Time 3. [ Time Frame: Time 1: sea level, baseline, no treatment. Time 3: within the first two days of high altitude exposure, under treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak Exercise Oxygen Saturation [ Time Frame: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment. ] [ Designated as safety issue: No ]
  • Systolic Pulmonary Artery Pressure. [ Time Frame: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment. ] [ Designated as safety issue: No ]
  • Resting Energy Expenditure [ Time Frame: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment. ] [ Designated as safety issue: No ]
  • Sitting Blood Pressure and Heart Rate [ Time Frame: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment. ] [ Designated as safety issue: No ]
  • Mean 24 Hour/Daytime/Night-time Blood Pressure and Heart Rate [ Time Frame: Time 1: sea level, baseline, no treatment. Time 2: sea level, after three weeks of allocated treatment. Time 3: within the first two days of high altitude exposure, under treatment. ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: May 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
Placebo tablets. One tablet twice daily.
Drug: placebo
placebo tablet BID
Active Comparator: 2: Carvedilol
Carvedilol 25 mg tablets. One tablet twice daily.
Drug: Carvedilol
Carvedilol 25 mg tablets. One tablet twice daily.
Active Comparator: 3: Nebivolol
Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
Drug: Nebivolol
nebivolol 5 mg tablets. One nebivolol tablet daily. One placebo tablet daily.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Men or women of any racial background
  • healthy
  • sealevel resident
  • age >= 18 years, =< 65 years
  • SBP< 130 mmHg and DBP< 80 mmHg, average of two measures at the sceening visit
  • FG < 100 mg/dl (5.6 mmol/l)
  • BMI < 25
  • written informed consent signed

Exclusion Criteria

  • engagement in regular exercise training
  • smoking habit
  • being enrolled in another research study
  • any current or previous cardiovascular, metabolic disease or any other cronic disease
  • any current treatment for any medical condition
  • any medical condition preventing or contraindication exposure to altitude hypoxia
  • any gastrointestinal disorder interfering with drug absorption
  • known allergy or contraindications to beta-blockers
  • pregnant or lactating women; women in reproductive age not using recognized contraceptive methods.
  • malignancy within the last 5 years
  • drug abuse or alcohol abuse within the last 5 years
  • history of noncompliance to medical regimens
  • incapacity or unwillingness to sign the informed consent
  • participation in any investigational clinical trial within the last 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00924833

Locations
Italy
Laboratorio Ricerche Cardiologiche. Istituto Auxologico Italiano. Ospedale S. Luca. Via Spagnoletto, 3. Regina Margherita Hut (Monte Rosa, Italian Alps, 4559 m)
Milan, Italy, 20148
Sponsors and Collaborators
Istituto Auxologico Italiano
Menarini Group
  More Information

Publications:
Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A, Vahanian A, Camm J, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Erdine S, Kiowski W, Agabiti-Rosei E, Ambrosioni E, Lindholm LH, Viigimaa M, Adamopoulos S, Agabiti-Rosei E, Ambrosioni E, Bertomeu V, Clement D, Erdine S, Farsang C, Gaita D, Lip G, Mallion JM, Manolis AJ, Nilsson PM, O'Brien E, Ponikowski P, Redon J, Ruschitzka F, Tamargo J, van Zwieten P, Waeber B, Williams B; Management of Arterial Hypertension of the European Society of Hypertension; European Society of Cardiology. 2007 Guidelines for the Management of Arterial Hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). J Hypertens. 2007 Jun;25(6):1105-87. No abstract available. Erratum in: J Hypertens. 2007 Aug;25(8):1749.

Responsible Party: Gianfranco Parati, Professor, Istituto Auxologico Italiano, Milan, Italy
ClinicalTrials.gov Identifier: NCT00924833     History of Changes
Other Study ID Numbers: 09F602
Study First Received: February 19, 2009
Results First Received: February 19, 2009
Last Updated: September 1, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Istituto Auxologico Italiano:
hypoxia
autonomic nervous system
blood pressure
heart rate
exercise
heart failure
receptors, adrenergic, beta.

Additional relevant MeSH terms:
Heart Failure
Anoxia
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Carvedilol
Nebivolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic beta-1 Receptor Antagonists

ClinicalTrials.gov processed this record on August 19, 2014