Comparison of Cardiac Rehabilitation Benefits Between Coronary and Non-coronary Patients Through a 24 Months Follow-up After Myocardial Infarction: the "INCARD" Study — INCARD  

Heart Failure Clinical Trial

Official title: Comparison of Cardiac Rehabilitation Benefits Between Coronary and Non-coronary Patients Through a 24 Months Follow-up : the "INCARD" Study

Status Recruiting

Clinical Trial Summary

Treatment of chronic heart failure requires multidisciplinary approaches with a recognized role for cardiac rehabilitation. Rehabilitation helps to improve patient's functional, decrease morbidity and mortality, decrease rehospitalization rate, thereby reducing costs of this disease. After recovery from the acute phase of cardiac infarction, patients admitted to the rehabilitation center will follow the usual rehabilitation program during the hospitalization period. This step precludes outpatient follow-up period in our day hospital, in accordance with their physicians and cardiologists who manage the monitoring. The study INCARD (Insuffisance Cardiaque en Readaptation Durable) will be developed to evaluate the benefits of a sustainable rehabilitation heart failure on patients treated optimally and educated during a follow-up period of 24 months. The main objective of the study will be to compare the benefits of rehabilitation between coronary (C) and non-coronary (NC) patients for each evaluation time point, periodically recorded

Clinical Trial Description

We will undertake a prospective follow-up study of 150 rehabilitated patients with heart failure (75 C; 75 NC). The main objective will be to compare the benefits of rehabilitation between coronary and non-coronary patients based on functional improvement i.e. improvements of VO2max, LVEF (ultrasound method and/or isotopic), 6-min walk test, Minnesota index of quality of life. In addition, clinical outcomes (HR, SBP, DBP, BMI) and paraclinical data (creatinine clearance) will be measured as patients' standard clinical follow-up .

Clinical data of the patients admitted to the cardiac rehabilitation, including heart failure patients (LVEF <40), will be recorded after collection of their signed informed consent agreement. Patients will be addressed from heart failure intensive care units for coronary (USIC) or acute cardiac services to the rehabilitation department. Patients will be admitted in the rehabilitation department when there are clinically stable (at least three weeks after the acute episode). Etiology of the heart failure will be assessed and patients stratified as C or NC patients.

Expected Results We will estimate the mean duration of inpatient rehabilitation (H period). Then, we will follow patients' cardiac evaluation parameters recorded from an outpatient follow-up, first 3 months after inclusion and then every 6 months over the 24 months of outpatient follow-up.

These data will allow for comparison of the benefits of rehabilitation between coronary (C) and non-coronary (NC) patients for each evaluation time point and will give information on the clinical improvement of each group of patients. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Myocardial Infarction

• NCT number: NCT01683903
• Study type: Observational
• Source: Centre Hospitalier Sud Francilien
• Status: Recruiting
• Phase: N/A
• Start date: August 2012
• Completion date: August 2014