Psychosocial Patterns and Prognosis in Patients With Heart Failure

Completed

• Conditions: Diastolic Heart Failure; Systolic Heart Failure

• Registration Number: NCT00709241
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-22
• Last Update Posted: 2014-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

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,

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular mortality	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hopital Georges pompidou; 🇫🇷 Paris, France