Vascular Effects of Sertraline in Heart Failure

This study has been terminated.

( PI change in institution )

First Received on December 22, 2007. Last Updated on July 22, 2009 History of Changes

Sponsor:	Yale University
Collaborator:	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

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:

MedlinePlus related topics: Depression Heart Failure

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

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

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

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

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

No publications provided

Responsible Party:	Stuart Katz, Yale University School of Medicine
ClinicalTrials.gov Identifier:	NCT00585455 History of Changes
Other Study ID Numbers:	0410027131
Study First Received:	December 22, 2007
Last Updated:	July 22, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

vascular endothelium
nitric oxide
depression
heart failure
vascular biology

Additional relevant MeSH terms:

Depression
Depressive Disorder
Heart Failure
Behavioral Symptoms
Mood Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases
Sertraline
Antidepressive Agents

Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012