Psychosocial Patterns and Prognosis in Patients With Heart Failure

Diastolic Heart Failure Clinical Trial

— PANIC  

Official title:

Prognostic Value of Negative Affectivity in Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709241
• Other study ID #: P051044
• Status: Completed
• Phase: N/A
• First received: July 2, 2008
• Last updated: October 22, 2014
• Start date: December 2007
• Est. completion date: December 2012

Study information

• Verified date: October 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Failure
• Heart Failure, Diastolic
• Heart Failure, Systolic
• Systolic Heart Failure

Locations

Country	Name	City	State
France	Hopital Georges pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular mortality		2 years	No
Secondary	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	No