Influence of Angiotensin Converting Enzyme (ACE) Genotype... | NCT00361127

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

NCT00361127

Sponsor

Piergiuseppe Agostoni

Status

Completed

Last Update Posted

Jan 28, 2016Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Heart Failure, Congestive

Interventions

isotonic saline infusion

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Aug 4, 2006

First Submission Date that Met QC Criteria

Aug 4, 2006

First Posted Date

Aug 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2016

Last Update Posted Date

Jan 28, 2016Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CMPD patients	Experimental	Patients with CMPD with evaluation of ACE I/D polymorphism	Drug: isotonic saline infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
isotonic saline infusion	Drug		CMPD patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Piergiuseppe Agostoni, MD.PhD	Centro Cardiologico Monzino	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Cardiologico Monzino		Milan		20138	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14581402	Background	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.
9107182	Background	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.

ID	Term
D006333	Heart Failure
D011654	Pulmonary Edema

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases