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

Heart Failure Clinical Trial

— INCARD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01683903
• Other study ID #: INCARD
• Status: Recruiting
• Phase: N/A
• First received: August 10, 2012
• Last updated: September 10, 2012
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: September 2012
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18 years old,

• Signed informed consent,

• Patients with left ventricular ejection fraction below 40 %,

• Stable for over 3 weeks,

• Known etiology,

• Able to do the performance test on treadmil or bicycle in order to have rehabilitation.

• No clinical avoidance reasons.

• Patient with health care registration.

• Agreement from the general practictioner and from the cardiologist that follows the patient.

Exclusion Criteria:

• Age below 18 years old,

• Unstable heart failure,

• Unable to do a performance test as indicated above,

• Patients not able to understand clinical counseling.

• Patient under tutella.

• Pregnancy.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Myocardial Infarction

Locations

Country	Name	City	State
France	Centre Hospitalien Sud Francilien	Corbeil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

References & Publications (1)

Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Strömberg A, van Veldhuisen DJ, Atar D, Hoes AW, Keren A, Mebazaa A, Nieminen M, Priori SG, Swedberg K; ESC Committee for Practice Guidelines (CPG). ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur Heart J. 2008 Oct;29(19):2388-442. doi: 10.1093/eurheartj/ehn309. Epub 2008 Sep 17. Review. Erratum in: Eur Heart J. 2010 Apr;12(4):416. Dosage error in article text. Eur Heart J. 2010 Mar;31(5):624. Dosage error in article text. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VO2max every 6 months over the 24 months	VO2max (L)	every 6 months over the 24 months of outpatient follow-up	No
Primary	Change in Left ventricular ejection fraction every 6 months over the 24 months of outpatient follow-up	Left ventricular ejection fraction (ultrasound method and/or isotopic) in %	every 6 months over the 24 months of outpatient follow-up	No
Primary	Change on 6-min walk test every 6 months over the 24 months	6-min walk test (m)	every 6 months over the 24 months of outpatient follow-up	No
Primary	Change on Minnesota index of quality of life every 6 months over the 24 months	Minnesota index of quality of life.	every 6 months over the 24 months of outpatient follow-up	No
Primary	Change on heart rate every 6 months over the 24 months	Heart rate (bpm)	every 6 months over the 24 months of outpatient follow-up	No
Primary	Change on systolic blood pressure every 6 months over the 24 months	systolic blood pressure (mmHg)	every 6 months over the 24 months of outpatient follow-up	No
Primary	Change on diastolic blood pressure every 6 months over the 24 months	diastolic blood pressure (mmHg)	every 6 months over the 24 months of outpatient follow-up	No
Primary	Change on body mass index every 6 months over the 24 months	Measurement of weight and height, calculation of body mass index (kg/m2)	every 6 months over the 24 months of outpatient follow-up	No
Primary	Change on creatine clearance every 6 months over the 24 months	creatine clearance (ml/min)	every 6 months over the 24 months of outpatient follow-up	No