Psychosocial Patterns and Prognosis in Patients With Heart Failure (PANIC)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2008 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT00709241

First received: July 2, 2008

Last updated: NA

Last verified: January 2008

History: No changes posted

Tracking Information

First Received Date ^ICMJE

July 2, 2008

Last Updated Date

July 2, 2008

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cardiovascular mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Psychosocial Patterns and Prognosis in Patients With Heart Failure

Official Title ^ICMJE

Prognostic Value of Negative Affectivity in Patients With Heart Failure

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Biospecimen

Retention: Samples Without DNA

Description:

serum, urine.

Sampling Method

Non-Probability Sample

Study Population

heart failure patients

Condition ^ICMJE

Systolic Heart Failure
Diastolic Heart Failure

Intervention ^ICMJE

Study Group/Cohort (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

700

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: François LEDRU, MD PH

+33 (0)1 56 09 36 14

francois.ledru@egp.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00709241

Other Study ID Numbers ^ICMJE

P051044

Has Data Monitoring Committee

Responsible Party

Cecile JOURDAIN, Department clinical research

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

François LEDRU, MD PH

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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