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

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: NCT00924833
Recruitment Status : Completed
First Posted : June 19, 2009
Results First Posted : June 19, 2009
Last Update Posted : September 2, 2009
Sponsor:
Collaborator:
Menarini Group
Information provided by:
Istituto Auxologico Italiano

Brief Summary:
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 or disease Intervention/treatment Phase
Hypoxia Altitude Heart Failure Drug: placebo Drug: Carvedilol Drug: Nebivolol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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.
Study Start Date : May 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

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Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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. ]
    Oxygen consumption at peak of exercise

  2. 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. ]
    Difference in peak exercise oxygen consumption between Time 1 and Time 3 (Time 3 - Time 1)

  3. 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. ]
    Minute ventilation at peak of exercise. Minute ventilation = tidal volume (ml) multiplied by the respiratory rate (breaths/min)

  4. 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. ]

    Difference in peak exercise minute ventilation between Time 1 and Time 3 (Time 3 - Time 1.

    Minute ventilation = tidal volume (ml) multiplied by the respiratory rate (breaths/min).



Secondary Outcome Measures :
  1. 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. ]
    Oxygen saturation by pulse oxymetry at peak of exercise

  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924833


Locations
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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
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. Erratum in: J Hypertens. 2007 Aug;25(8):1749.

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Responsible Party: Gianfranco Parati, Professor, Istituto Auxologico Italiano, Milan, Italy
ClinicalTrials.gov Identifier: NCT00924833    
Other Study ID Numbers: 09F602
First Posted: June 19, 2009    Key Record Dates
Results First Posted: June 19, 2009
Last Update Posted: September 2, 2009
Last Verified: February 2009
Keywords provided by Istituto Auxologico Italiano:
hypoxia
autonomic nervous system
blood pressure
heart rate
exercise
heart failure
receptors, adrenergic, beta.
Additional relevant MeSH terms:
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Heart Failure
Hypoxia
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms, Respiratory
Carvedilol
Nebivolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists