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CompletedNCT00709241PANICUpdated Oct 23, 2014

Psychosocial Patterns and Prognosis in Patients With Heart Failure

An observational study in Systolic Heart Failure and Diastolic Heart Failure, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-23.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
325
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Studies suggest that depressive symptoms may be associated with a worse prognosis and higher costs of care in patients with chronic heart failure in some populations, but such data in a French population are missing. On the other hand, little is known of the impact of other psychosocial dysfunction whereas the pathophysiology of this association remains hypothetical.

Main objective: to confirm the impact of depressive symptoms on cardiovascular death in ambulatory heart failure patients

Other objectives:

  • to study the impact of depressive symptoms on sudden death, non cardiovascular death, and hospitalization rates;
  • to study the role of other psychosocial patterns or personality traits such as anxiety disorders, locus of control, perceived social support, anger, hopelessness, optimism and type D personality in cardiovascular and total mortality;
  • to study the interaction with patient behaviors (drug compliance, addictions);
  • to explore some pathophysiological pathways (chronic inflammation and chronic loss of myocytes),
  • and to evaluate the impact of psychosocial distress on health care costs. Design: multicenter observational study with a minimum of 2 year follow up Population: 700 ambulatory patients, aged above 18 y.o., with acute heart failure within the last 24 months

Methodology:

  • psychosocial patterns and personality traits are assessed using validated self-administered questionnaire; use of the Beck Depression Index in this population is validated against the Montgomery \& Asberg Depression Rating Scale evaluation
  • cardiac condition is evaluated at pre-defined time period by B-natriuretic peptide levels, echocardiography and 6'-walk test

End-point criteria:

  • primary : rate of cardiovascular death
  • secondary : rate of total mortality and sudden death, rate of rehospitalization for heart failure and for any cause, total and specific health care costs.
02

Conditions studied

  • Systolic Heart Failure
  • Diastolic Heart Failure

Keywords

  • Heart failure
  • Psychosocial factors
  • Depression
  • Patient compliance
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 325 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

heart failure patients

Inclusion criteria

  • 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,

Exclusion criteria

Exclusion Criteria:

  • Non inclusion criteria :
  • curable cardiomyopathy, cardiomyopathies associated with systemic illnesses (Lupus...), neurodegenerative or pulmonary illnesses, or hypertrophic/restrictive cardiomyopathy
  • unstable cardiovascular condition
  • heart transplant and hemodialysis patient
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
325 participants (actual)
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Cardiovascular mortality

    Time frame: 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

    Time frame: 2 years

07

Study locations

1 site
  • Hopital Georges pompidou
    Paris, 75015, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00709241
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jul 3, 2008
Start date
Dec 2007
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Oct 23, 2014

Study contacts

François LEDRU, MD PH
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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