We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00709241
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : October 23, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Systolic Heart Failure Diastolic Heart Failure

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


  • 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 Design

Study Type : Observational
Actual Enrollment : 325 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of Negative Affectivity in Patients With Heart Failure
Study Start Date : December 2007
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Cardiovascular mortality [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples Without DNA
serum, urine.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
heart failure patients

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709241

Hopital Georges pompidou
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: François LEDRU, MD PH Assistance Publique - Hôpitaux de Paris
More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00709241     History of Changes
Other Study ID Numbers: P051044
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: October 23, 2014
Last Verified: October 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Heart failure
Psychosocial factors
Patient compliance

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases