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

January 27, 2016 updated by: Piergiuseppe Agostoni

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20138
        • Centro Cardiologico Monzino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Possible identification of a genetic pattern responsible for different responses to ACE-inhibition during fluid overload in heart failure
Time Frame: Third day
Third day

Secondary Outcome Measures

Outcome Measure
Time Frame
Influence of ACE-genotype on exercise capacity
Time Frame: Third day
Third day
Influence of ACE-genotype on lung function
Time Frame: Third day
Third day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Piergiuseppe Agostoni

Investigators

  • Principal Investigator: Piergiuseppe Agostoni, MD.PhD, Centro Cardiologico Monzino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 4, 2006

First Submitted That Met QC Criteria

August 4, 2006

First Posted (Estimate)

August 7, 2006

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCM S65/206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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