Vascular Effects of Sertraline in Heart Failure

This study is currently recruiting participants.

Verified by Yale University, June 2008

Sponsors and Collaborators:	Yale University Pfizer
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00585455

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

MedlinePlus related topics: Depression Heart Failure

Drug Information available for: Sertraline hydrochloride Sertraline Nitric oxide

U.S. FDA Resources

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

Further study details as provided by Yale University:

Primary Outcome Measures:

Brachial artery flow-mediated dilation [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Plasma and serum

Estimated Enrollment:	20
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (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

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585455

Contacts

Contact: Stuart Katz, MD	203-785-7191	stuart.katz@yale.edu
Contact: Patti Cavaliere	203-785-7191	patti.cavaliere@yale.edu

Locations

United States, Connecticut
Yale University School of Medicine	Recruiting
New Haven, Connecticut, United States, 06510
Contact: Stuart Katz 203-785-7191 stuart.katz@yale.edu
Principal Investigator: Stuart Katz, MD

Sponsors and Collaborators

Yale University

Pfizer

Investigators

Principal Investigator:

Stuart Katz, MD

Yale School of Medicine

More Information

Responsible Party:	Yale University School of Medicine ( Stuart Katz )
Study ID Numbers:	0410027131
Study First Received:	December 22, 2007
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00585455
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

vascular endothelium
nitric oxide
depression
heart failure
vascular biology

Study placed in the following topic categories:

Nitric Oxide
Heart Failure
Heart Diseases
Depression
Mental Disorders

Mood Disorders
Sertraline
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Cardiovascular Diseases
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009