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

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ClinicalTrials.gov Identifier: NCT00361127
Recruitment Status : Completed
First Posted : August 7, 2006
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Piergiuseppe Agostoni, Centro Cardiologico Monzino

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure, Congestive Drug: isotonic saline infusion Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Study Start Date : August 2006
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: CMPD patients
Patients with CMPD with evaluation of ACE I/D polymorphism
Drug: isotonic saline infusion



Primary Outcome Measures :
  1. 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 :
  1. Influence of ACE-genotype on exercise capacity [ Time Frame: Third day ]
  2. Influence of ACE-genotype on lung function [ Time Frame: Third day ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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


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

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

Keywords provided by Piergiuseppe Agostoni, 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