Psychosocial Patterns and Prognosis in Patients With Heart Failure
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.
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Conditions
Systolic Heart Failure
Location
Hopital Georges pompidou
Paris
France
75015
Status
Recruiting
Source
Assistance Publique - Hôpitaux de Paris
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00709241
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cardiomegaly
Enlargement of the HEART, usually indicated by a cardiothoracic ratio above 0.50. Heart enlargement may involve the right, the left, or both HEART VENTRICLES or HEART ATRIA. Cardiomegaly is a nonspecific symptom seen in patients with chronic systolic heart failure (HEART FAILURE) or several forms of CARDIOMYOPATHIES.
Heart Failure, Systolic
Heart failure caused by abnormal myocardial contraction during SYSTOLE leading to defective cardiac emptying.
Heart Failure
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.
Systolic Murmurs
Heart murmurs which are systolic in timing. They occur between the first and the second HEART SOUNDS, between the closure of MITRAL VALVE and TRICUSPID VALVE and the closure of semilunar aortic and pulmonary valves. Systolic murmurs include ejection murmurs and regurgitant murmurs.
Xamoterol
A selective beta-1-adrenergic partial agonist. Because it is a partial agonist (DRUG PARTIAL AGONISM) it acts like an agonist when sympathetic activity is low and as an antagonist when sympathetic activity is high. It reduces MYOCARDIAL ISCHEMIA and improves ventricular function in patients with mild to moderate heart failure. In patients with severe heart failure it has been shown to produce benefits in systolic and diastolic function.
Clinical Trials
Aims: To test the hypothesis that Diastolic dysfunction severity correlates with adverse clinical outcome in patients with systolic heart failure.
Assessment of Cardiac Functional Reserve in Heart Failure With Preserved Ejection Fraction (HF-PEF)
This study will compare the ability of the heart to increase its contractile performance during stress in patients with a history of heart failure without systolic dysfunction and in contr...
Platelet Inhibition in Patients With Systolic Heart Failure
The investigators aim to determine if patients with systolic heart failure treated with prasugrel achieve greater platelet inhibition compared to those treated with clopidogrel.
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserve...
In addition to the blood pressure lowering effects of aliskiren, it may have beneficial effects on blocking the so called RAAS (renin-angiotensin-aldosterone system) at the tissue level. A...
PubMed Articles
Eplerenone in patients with systolic heart failure and mild symptoms.
Mineralocorticoid antagonists improve survival among patients with chronic, severe systolic heart failure and heart failure after myocardial infarction. We evaluated the effects of eplerenone in patie...
Heart failure update 2010 and current ESC guidelines.
Chronic heart failure may be caused by systolic pump failure and/or impairment of diastolic filling of the ventricles. Standard pharmacotherapy of systolic heart failure includes an ACE inhibitor, bet...
Systolic and diastolic heart failure are overlapping phenotypes within the heart failure spectrum.
Although the prognosis of systolic heart failure, also called heart failure with reduced ejection fraction, has improved with advances in therapy, the prognosis remains poor in patients who become ref...
BACKGROUND: Corin is a serine protease that cleaves pro-atrial and pro-B-type natriuretic peptides into biologically active hormones. The relationship between soluble plasma corin levels, plasma natri...
