Influence of Angiotensin Converting Enzyme (ACE) Genotype on Lung Diffusion in Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piergiuseppe Agostoni, Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:
NCT00361127
First received: August 4, 2006
Last updated: January 27, 2016
Last verified: January 2016
  Purpose
In patients with chronic heart failure ACE-inhibitor treatment improves lung diffusion and prevents pulmonary edema after fluid overload. In the western country, 3 population types of ACE genotypes exist (DD, ID, II). It is unknown whether the ACE genotype influences the response to fluid overload in ACE-inhibitor treated chronic heart failure patients.

Condition Intervention
Heart Failure, Congestive
Drug: isotonic saline infusion

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Influence of ACE Genotype on Lung Diffusion at Rest and After Fluid Overload in Heart Failure Patients Treated With ACE-inhibitors

Resource links provided by NLM:


Further study details as provided by Centro Cardiologico Monzino:

Primary Outcome Measures:
  • Possible identification of a genetic pattern responsible for different responses to ACE-inhibition during fluid overload in heart failure [ Time Frame: Third day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Influence of ACE-genotype on exercise capacity [ Time Frame: Third day ] [ Designated as safety issue: No ]
  • Influence of ACE-genotype on lung function [ Time Frame: Third day ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: August 2006
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CMPD patients
Patients with CMPD with evaluation of ACE I/D polymorphism
Drug: isotonic saline infusion

Detailed Description:
Patients with chronic heart failure in stable clinical condition treated with ACE-inhibitors, but not aspirin, will be evaluated by means of maximal cardiopulmonary exercise test and lung function including lung diffusion measurements. These tests will be done before and after rapid 500 ml isotonic saline infusion. Patients will be grouped according to their ACE genotype.
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New York Heart Association (NYHA) class I and II heart failure
  • Chronic ACE-inhibitor treatment

Exclusion Criteria:

  • Aspirin treatment in the previous 2 months
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00361127

Locations
Italy
Centro Cardiologico Monzino
Milan, Italy, 20138
Sponsors and Collaborators
Piergiuseppe Agostoni
Investigators
Principal Investigator: Piergiuseppe Agostoni, MD.PhD Centro Cardiologico Monzino
  More Information

Publications:
Responsible Party: Piergiuseppe Agostoni, MD PhD, Centro Cardiologico Monzino
ClinicalTrials.gov Identifier: NCT00361127     History of Changes
Other Study ID Numbers: CCM S65/206 
Study First Received: August 4, 2006
Last Updated: January 27, 2016
Health Authority: Italy: Ministry of Health

Keywords provided by Centro Cardiologico Monzino:
Heart failure
pulmonary edema
ACE-inhibitors
lung diffusion
exercise capacity
Chronic heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 25, 2016