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Vascular Effects of Sertraline in Heart Failure

This study has been terminated.
(PI change in institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00585455
First Posted: January 3, 2008
Last Update Posted: July 24, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by:
Yale University
  Purpose
To determine the effects of chronic sertraline treatment on brachial artery flow-mediated dilation in patients with chronic heart failure and depression

Condition Intervention
Heart Failure Depression Drug: sertraline

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Chronic Sertraline Hydrochloride Administration on Vascular Endothelial and Autonomic Function in Patients With Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilation [ Time Frame: 2 months ]

Biospecimen Retention:   Samples Without DNA
Plasma and serum

Enrollment: 4
Study Start Date: January 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
Chronic heart failure patients with concomitant depression
Drug: sertraline
open label 25-50 mg daily as tolerated

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
chronic heart failure patients with concomitant depression
Criteria

Inclusion Criteria:

  • Chronic heart failure with LVEF<40%, age >21 years
  • Depression requiring medical treatment with sertraline

Exclusion Criteria:

  • Known intolerance of sertraline
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585455


Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Pfizer
Investigators
Principal Investigator: Stuart Katz, MD Yale School of Medicine
  More Information

Responsible Party: Stuart Katz, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00585455     History of Changes
Other Study ID Numbers: 0410027131
First Submitted: December 22, 2007
First Posted: January 3, 2008
Last Update Posted: July 24, 2009
Last Verified: July 2009

Keywords provided by Yale University:
vascular endothelium
nitric oxide
depression
heart failure
vascular biology

Additional relevant MeSH terms:
Depression
Heart Failure
Behavioral Symptoms
Heart Diseases
Cardiovascular Diseases
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs