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

NCT ID: NCT00361127

Last Updated: 2016-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure, Congestive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CMPD patients

Patients with CMPD with evaluation of ACE I/D polymorphism

Group Type EXPERIMENTAL

isotonic saline infusion

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

isotonic saline infusion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Piergiuseppe Agostoni

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Piergiuseppe Agostoni

MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Piergiuseppe Agostoni, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Centro Cardiologico Monzino

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centro Cardiologico Monzino

Milan, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 14581402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9107182 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCM S65/206

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tezosentan in Acute Heart Failure
NCT00525707 COMPLETED PHASE3