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
Recruitment status was Recruiting
Sponsor:
Centro Cardiologico Monzino
Information provided by:
Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:
NCT00361127
First received: August 4, 2006
Last updated: October 19, 2006
Last verified: August 2006
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 4, 2006 | ||||||||
| Last Updated Date | October 19, 2006 | ||||||||
| Start Date ICMJE | August 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Possible identification of a genetic pattern responsible for different responses to ACE-inhibition during fluid overload in heart failure | ||||||||
| Original Primary Outcome Measures ICMJE |
Possible identification of a genetic pattern responsible for different response to ACE-inhibition during fluid overload in heart failure. | ||||||||
| Change History | Complete list of historical versions of study NCT00361127 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Influence of Angiotensin Converting Enzyme (ACE) Genotype on Lung Diffusion in Heart Failure | ||||||||
| Official Title ICMJE | Influence of ACE Genotype on Lung Diffusion at Rest and After Fluid Overload in Heart Failure Patients Treated With ACE-Inhibitors | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Heart Failure, Congestive | ||||||||
| Intervention ICMJE | Drug: isotonic saline infusion | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 50 | ||||||||
| Completion Date | August 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00361127 | ||||||||
| Other Study ID Numbers ICMJE | CCM S65/206 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Centro Cardiologico Monzino | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centro Cardiologico Monzino | ||||||||
| Verification Date | August 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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