NCT00517725

Brief Summary

The investigators test the hypothesis that different beta-blockers had a different influence on chemoreceptor response and lung diffusion capacity. Both could influence exercise capacity in normoxic as well as hypoxic conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 16, 2010

Status Verified

September 1, 2010

First QC Date

August 16, 2007

Last Update Submit

September 15, 2010

Conditions

Chronic Heart Failure

Keywords

exerciselung diffusionhypoxiachemoreceptorbeta-blockersheart failure

Outcome Measures

Primary Outcomes (1)

  • exercise capacity

    two months

Secondary Outcomes (1)

  • lung diffusion

    two months

Study Arms (3)

Carvedilol

ACTIVE COMPARATOR
Drug: carvedilol

Bisoprolol

ACTIVE COMPARATOR
Drug: bisoprolol

Nebivolol

ACTIVE COMPARATOR
Drug: Nebivolol

Interventions

carvedilolDRUG
Carvedilol
bisoprololDRUG
Bisoprolol
NebivololDRUG
Nebivolol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic heart failure patients in stable clinical condition

You may not qualify if:

  • No comorbidity
  • NYHA class IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cardiologico Monzino, University of Milan

Milan, 20138, Italy

Location

Related Publications (2)

  • Agostoni P, Bussotti M, Cattadori G, Margutti E, Contini M, Muratori M, Marenzi G, Fiorentini C. Gas diffusion and alveolar-capillary unit in chronic heart failure. Eur Heart J. 2006 Nov;27(21):2538-43. doi: 10.1093/eurheartj/ehl302. Epub 2006 Oct 6.

    PMID: 17028107BACKGROUND

  • Karsten M, Contini M, Cefalu C, Cattadori G, Palermo P, Apostolo A, Bussotti M, Magri D, Salvioni E, Farina S, Sciomer S, Catai AM, Agostoni P. Effects of carvedilol on oxygen uptake and heart rate kinetics in patients with chronic heart failure at simulated altitude. Eur J Prev Cardiol. 2012 Jun;19(3):444-51. doi: 10.1177/1741826711402736. Epub 2011 Mar 7.

    PMID: 21450573DERIVED

MeSH Terms

Conditions

Motor ActivityHypoxiaHeart Failure

Interventions

CarvedilolBisoprololNebivolol

Condition Hierarchy (Ancestors)

BehaviorSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingPhenoxypropanolaminesEthanolaminesBenzopyransPyransHeterocyclic Compounds, 1-Ring

Study Officials

  • Piergiuseppe Agostoni, MD, PhD

    Centro Cardiologico Monzino

    PRINCIPAL INVESTIGATOR

  • Giancarlo Marenzi, MD

    Centro Cardiologico Monzino

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 17, 2007

Study Start

July 1, 2007

Study Completion

May 1, 2010

Last Updated

September 16, 2010

Record last verified: 2010-09

Locations

IT(1)