Vascular Effects of Sertraline in Heart Failure
This study has been terminated.
(PI change in institution)
Sponsor:
Yale University
Collaborator:
Pfizer
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00585455
First received: December 22, 2007
Last updated: July 22, 2009
Last verified: July 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 22, 2007 | ||||
| Last Updated Date | July 22, 2009 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Brachial artery flow-mediated dilation [ Time Frame: 2 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00585455 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vascular Effects of Sertraline in Heart Failure | ||||
| Official Title ICMJE | Effects of Chronic Sertraline Hydrochloride Administration on Vascular Endothelial and Autonomic Function in Patients With Chronic Heart Failure | ||||
| Brief Summary | To determine the effects of chronic sertraline treatment on brachial artery flow-mediated dilation in patients with chronic heart failure and depression |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Plasma and serum |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | chronic heart failure patients with concomitant depression |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: sertraline
open label 25-50 mg daily as tolerated |
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| Study Group/Cohort (s) | A
Chronic heart failure patients with concomitant depression
Intervention: Drug: sertraline |
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| Publications * | Not Provided | ||||
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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 | Terminated | ||||
| Enrollment ICMJE | 4 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00585455 | ||||
| Other Study ID Numbers ICMJE | 0410027131 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Stuart Katz, Yale University School of Medicine | ||||
| Study Sponsor ICMJE | Yale University | ||||
| Collaborators ICMJE | Pfizer | ||||
| Investigators ICMJE |
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| Information Provided By | Yale University | ||||
| Verification Date | July 2009 | ||||
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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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