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

Heart Failure, Congestive Clinical Trial

Official title:

Influence of ACE Genotype on Lung Diffusion at Rest and After Fluid Overload in Heart Failure Patients Treated With ACE-inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361127
• Other study ID #: CCM S65/206
• Status: Completed
• Phase: N/A
• First received: August 4, 2006
• Last updated: January 27, 2016
• Start date: August 2006
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: Centro Cardiologico Monzino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• isotonic saline infusion

Locations

Country	Name	City	State
Italy	Centro Cardiologico Monzino	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Piergiuseppe Agostoni

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Agostoni P, Cattadori G, Bianchi M, Wasserman K. Exercise-induced pulmonary edema in heart failure. Circulation. 2003 Nov 25;108(21):2666-71. Epub 2003 Oct 27. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Possible identification of a genetic pattern responsible for different responses to ACE-inhibition during fluid overload in heart failure		Third day	No
Secondary	Influence of ACE-genotype on exercise capacity		Third day	No
Secondary	Influence of ACE-genotype on lung function		Third day	No