- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00709241
Psychosocial Patterns and Prognosis in Patients With Heart Failure (PANIC)
Prognostic Value of Negative Affectivity in Patients With Heart Failure
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75015
- Hopital Georges Pompidou
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiovascular mortality
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: François LEDRU, MD PH, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P051044
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diastolic Heart Failure
-
Emory UniversityUnknownDiastolic Heart Failure | Diastolic DysfunctionUnited States
-
CorAssist Cadiovascular Ltd.RecruitingDiastolic Heart Failure | Diastolic DysfunctionIsrael
-
University of VermontCompletedDiastolic Heart Failure | Diastolic Dysfunction | PacemakerUnited States
-
University of NebraskaTerminatedDiastolic Heart FailureUnited States
-
Arizona State UniversityMayo Clinic; University of AlbertaCompleted
-
University of Wisconsin, MadisonTerminatedDiastolic Heart FailureUnited States
-
University of PennsylvaniaCompletedHeart Failure | Diastolic Heart FailureUnited States
-
Chang Gung Memorial HospitalCompleted
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI); PfizerCompleted
-
St Vincent's University Hospital, IrelandCompletedThe Effect of Eplerenone and Atorvastatin on Markers of Collagen Turnover in Diastolic Heart FailureDiastolic Heart FailureIreland