Back to resultsInfluence of Angiotensin Converting Enzyme (ACE) Genotype on Lung Diffusion in Heart Failure
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
isotonic saline infusion
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure, Congestive focused on measuring Heart failure, pulmonary edema, ACE-inhibitors, lung diffusion, exercise capacity, Chronic heart failure
Eligibility 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
Sites / Locations
- Centro Cardiologico Monzino
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CMPD patients
Arm Description
Patients with CMPD with evaluation of ACE I/D polymorphism
Outcomes
Primary Outcome Measures
Possible identification of a genetic pattern responsible for different responses to ACE-inhibition during fluid overload in heart failure
Secondary Outcome Measures
Influence of ACE-genotype on exercise capacity
Influence of ACE-genotype on lung function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00361127
Brief Title
Influence of Angiotensin Converting Enzyme (ACE) Genotype on Lung Diffusion in Heart Failure
Official Title
Influence of ACE Genotype on Lung Diffusion at Rest and After Fluid Overload in Heart Failure Patients Treated With ACE-inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Piergiuseppe Agostoni
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Heart failure, pulmonary edema, ACE-inhibitors, lung diffusion, exercise capacity, Chronic heart failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CMPD patients
Arm Type
Experimental
Arm Description
Patients with CMPD with evaluation of ACE I/D polymorphism
Intervention Type
Drug
Intervention Name(s)
isotonic saline infusion
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Influence of ACE-genotype on exercise capacity
Time Frame
Third day
Title
Influence of ACE-genotype on lung function
Time Frame
Third day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piergiuseppe Agostoni, MD.PhD
Organizational Affiliation
Centro Cardiologico Monzino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Cardiologico Monzino
City
Milan
ZIP/Postal Code
20138
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
14581402
Citation
Agostoni P, Cattadori G, Bianchi M, Wasserman K. Exercise-induced pulmonary edema in heart failure. Circulation. 2003 Nov 25;108(21):2666-71. doi: 10.1161/01.CIR.0000097115.61309.59. Epub 2003 Oct 27.
Results Reference
background
PubMed Identifier
9107182
Citation
Guazzi M, Marenzi G, Alimento M, Contini M, Agostoni P. Improvement of alveolar-capillary membrane diffusing capacity with enalapril in chronic heart failure and counteracting effect of aspirin. Circulation. 1997 Apr 1;95(7):1930-6. doi: 10.1161/01.cir.95.7.1930.
Results Reference
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Influence of Angiotensin Converting Enzyme (ACE) Genotype on Lung Diffusion in Heart Failure
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