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| Sponsor: | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00709241 |
Purpose
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.
| Condition |
|---|
|
Systolic Heart Failure Diastolic Heart Failure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prognostic Value of Negative Affectivity in Patients With Heart Failure |
serum, urine.
| Estimated Enrollment: | 700 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
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:
Methodology:
End-point criteria:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
heart failure patients
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: François LEDRU, MD PH | +33 (0)1 56 09 36 14 | francois.ledru@egp.aphp.fr |
| France | |
| Hopital Georges pompidou | Recruiting |
| Paris, France, 75015 | |
| Principal Investigator: | François LEDRU, MD PH | Assistance Publique - Hôpitaux de Paris |
More Information
| Responsible Party: | Cecile JOURDAIN, Department clinical research |
| ClinicalTrials.gov Identifier: | NCT00709241 History of Changes |
| Other Study ID Numbers: | P051044 |
| Study First Received: | July 2, 2008 |
| Last Updated: | July 2, 2008 |
| Health Authority: | France: Ministry of Health |
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Heart failure Psychosocial factors Depression Patient compliance |
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Heart Failure Heart Failure, Systolic Heart Failure, Diastolic Heart Diseases Cardiovascular Diseases |