NCT00361127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2006

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

7.3 years

First QC Date

August 4, 2006

Last Update Submit

January 27, 2016

Conditions

Keywords

Heart failurepulmonary edemaACE-inhibitorslung diffusionexercise capacityChronic heart failure

Outcome Measures

Primary Outcomes (1)

  • Possible identification of a genetic pattern responsible for different responses to ACE-inhibition during fluid overload in heart failure

    Third day

Secondary Outcomes (2)

  • Influence of ACE-genotype on exercise capacity

    Third day

  • Influence of ACE-genotype on lung function

    Third day

Study Arms (1)

CMPD patients

EXPERIMENTAL

Patients with CMPD with evaluation of ACE I/D polymorphism

Drug: isotonic saline infusion

Interventions

CMPD patients

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New York Heart Association (NYHA) class I and II heart failure
  • Chronic ACE-inhibitor treatment

You may not qualify if:

  • Aspirin treatment in the previous 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Related 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. doi: 10.1161/01.CIR.0000097115.61309.59. Epub 2003 Oct 27.

    PMID: 14581402BACKGROUND
  • 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.

    PMID: 9107182BACKGROUND

MeSH Terms

Conditions

Heart FailurePulmonary Edema

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract Diseases

Study Officials

  • Piergiuseppe Agostoni, MD.PhD

    Centro Cardiologico Monzino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

August 4, 2006

First Posted

August 7, 2006

Study Start

August 1, 2006

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations