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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Centro Cardiologico Monzino.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:
NCT00361127
First received: August 4, 2006
Last updated: October 19, 2006
Last verified: August 2006
  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: Allocation: Non-Randomized
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

Secondary Outcome Measures:
  • Influence of ACE-genotype on exercise capacity
  • Influence of ACE-genotype on lung function

Estimated Enrollment: 50
Study Start Date: August 2006
Estimated Study Completion Date: August 2006
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361127

Contacts
Contact: Piergiuseppe Agostoni, MD-PhD +39 02 58002299 piergiuseppe.agostoni@ccfm.it
Contact: Mauro Contini, MD +39 02 58002525 mauro.contini@ccfm.it

Locations
Italy
Centro Cardiologico Monzino Recruiting
Milan, Italy, 20138
Contact: Piergiuseppe Agostoni, MD,PhD    +39 02 58002299    piergiuseppe.agostoni@ccfm.it   
Principal Investigator: Piergiuseppe Agostoni, MD,PhD         
Sponsors and Collaborators
Centro Cardiologico Monzino
Investigators
Principal Investigator: Piergiuseppe Agostoni, MD.PhD Centro Cardiologico Monzino
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00361127     History of Changes
Other Study ID Numbers: CCM S65/206
Study First Received: August 4, 2006
Last Updated: October 19, 2006
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014