NCT00709241

Brief Summary

This prospective observational study is designed to confirm the prognostic and economic impact of depression in ambulatory patients with systolic or diastolic heart failure, to explore the impact of other psychosocial patterns such as type D personality, anxiety disorders, locus of control, perceived social support, anger, hopelessness, and to evaluate potential pathophysiological and behavioral pathways.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 23, 2014

Status Verified

October 1, 2014

Enrollment Period

5 years

First QC Date

July 2, 2008

Last Update Submit

October 22, 2014

Conditions

Systolic Heart FailureDiastolic Heart Failure

Keywords

Heart failurePsychosocial factorsDepressionPatient compliance

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular mortality

    2 years

Secondary Outcomes (1)

  • total mortality, sudden death rate, non cardiovascular mortality, rate of hospitalization, of rehospitalization for heart failure, of hospitalization for cardiovascular and non cardiovascular reasons,total health care costs and nature of theses costs

    2 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

heart failure patients

You may qualify if:

  • age above 18,
  • acute heart failure within the last 24 months
  • stable cardiovascular condition for at least 2 weeks
  • non hospitalized, non institutionalized patient,
  • french speaking and reading,

You may not qualify if:

  • curable cardiomyopathy, cardiomyopathies associated with systemic illnesses (Lupus...), neurodegenerative or pulmonary illnesses, or hypertrophic/restrictive cardiomyopathy
  • unstable cardiovascular condition
  • heart transplant and hemodialysis patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Georges pompidou

Paris, 75015, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, urine.

MeSH Terms

Conditions

Heart Failure, SystolicHeart Failure, DiastolicHeart FailureDepressionPatient Compliance

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavioral SymptomsBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • François LEDRU, MD PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 3, 2008

Study Start

December 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

October 23, 2014

Record last verified: 2014-10

Locations

FR(1)