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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: August 7, 2006
Last Update Posted: January 28, 2016
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.
Information provided by (Responsible Party):
Piergiuseppe Agostoni, Centro Cardiologico Monzino
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: Intervention Model: Single Group Assignment
Masking: None (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 Piergiuseppe Agostoni, 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 ]

Secondary Outcome Measures:
  • Influence of ACE-genotype on exercise capacity [ Time Frame: Third day ]
  • Influence of ACE-genotype on lung function [ Time Frame: Third day ]

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.

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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): NCT00361127

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

Responsible Party: Piergiuseppe Agostoni, MD PhD, Centro Cardiologico Monzino
ClinicalTrials.gov Identifier: NCT00361127     History of Changes
Other Study ID Numbers: CCM S65/206
First Submitted: August 4, 2006
First Posted: August 7, 2006
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Piergiuseppe Agostoni, Centro Cardiologico Monzino:
Heart failure
pulmonary edema
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