NCT00585455

Brief Summary

To determine the effects of chronic sertraline treatment on brachial artery flow-mediated dilation in patients with chronic heart failure and depression

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

July 23, 2009

Status Verified

July 1, 2009

Enrollment Period

3.5 years

First QC Date

December 22, 2007

Last Update Submit

July 22, 2009

Conditions

Heart FailureDepression

Keywords

vascular endotheliumnitric oxidedepressionheart failurevascular biology

Outcome Measures

Primary Outcomes (1)

  • Brachial artery flow-mediated dilation

    2 months

Study Arms (1)

A

Chronic heart failure patients with concomitant depression

Drug: sertraline

Interventions

sertralineDRUG

open label 25-50 mg daily as tolerated

A

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

chronic heart failure patients with concomitant depression

You may qualify if:

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

You may not qualify if:

  • Known intolerance of sertraline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum

MeSH Terms

Conditions

Heart FailureDepression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Stuart Katz, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2007

First Posted

January 3, 2008

Study Start

January 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

July 23, 2009

Record last verified: 2009-07

Locations

US(1)