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Heart FailureINCARDNCT01683903

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

An observational study of Heart Failure, run by Centre Hospitalier Sud Francilien at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
How many people
150 participants
Where
1 siteFrance
Study dates
Aug 2012to Aug 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Chronic heart failure patients

Who may be able to join

  • 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.
Show all 9Show fewer
  • No clinical avoidance reasons.
  • Patient with health care registration.
  • Agreement from the general practictioner and from the cardiologist that follows the patient.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting

  • Centre Hospitalien Sud Francilien

    Corbeil, 91100

    Francois Koukoui, MD, 00(33)161698086, francois.koukoui@ch-sud-francilien.fr

    Francois Koukoui, MD

    Recruiting

Other trials in France

About this study

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

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

Read the detailed 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.

Conditions
Heart Failure
Keywords
heart failure, cardiac rehabilitation, myocardial infarction
Medical subject headings
Heart Failure, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01683903
Study groupRoleWhat they receive
Non coronary patients (NC)Patient with myocardial infarction with non-coronary (NC) etiology
Coronary patients (C)Patients with myocardial infarction due to coronary disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in VO2max every 6 months over the 24 months

    VO2max (L)

    Measured: every 6 months over the 24 months of outpatient follow-up

  2. 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 %

    Measured: every 6 months over the 24 months of outpatient follow-up

  3. Change on 6-min walk test every 6 months over the 24 months

    6-min walk test (m)

    Measured: every 6 months over the 24 months of outpatient follow-up

  4. Change on Minnesota index of quality of life every 6 months over the 24 months

    Minnesota index of quality of life.

    Measured: every 6 months over the 24 months of outpatient follow-up

  5. Change on heart rate every 6 months over the 24 months

    Heart rate (bpm)

    Measured: every 6 months over the 24 months of outpatient follow-up

  6. Change on systolic blood pressure every 6 months over the 24 months

    systolic blood pressure (mmHg)

    Measured: every 6 months over the 24 months of outpatient follow-up

  7. Change on diastolic blood pressure every 6 months over the 24 months

    diastolic blood pressure (mmHg)

    Measured: every 6 months over the 24 months of outpatient follow-up

  8. Change on body mass index every 6 months over the 24 months

    Measurement of weight and height, calculation of body mass index (kg/m2)

    Measured: every 6 months over the 24 months of outpatient follow-up

  9. Change on creatine clearance every 6 months over the 24 months

    creatine clearance (ml/min)

    Measured: every 6 months over the 24 months of outpatient follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionAug 2014 (estimated)
  4. Study completionAug 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01683903
Sponsor's protocol ID
INCARD
Acronym
INCARD
Status last verified
Sep 2012
First submitted
10 Aug 2012
Last updated
12 Sep 2012
Results posted
No
Data monitoring committee
No

Publications

  • Dickstein K, Cohen-Solal A, Filippatos G, McMurray JJ, Ponikowski P, Poole-Wilson PA, Stromberg 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. No abstract available.

    PubMed 18799522

  • Koukoui F, Desmoulin F, Lairy G, Bleinc D, Boursiquot L, Galinier M, Smih F, Rouet P. Benefits of cardiac rehabilitation in heart failure patients according to etiology: INCARD French study. Medicine (Baltimore). 2015 Feb;94(7):e544. doi: 10.1097/MD.0000000000000544.

    PubMed 25700319

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Centre Hospitalier Sud Francilien at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in VO2max every 6 months over the 24 months (time frame: every 6 months over the 24 months of outpatient follow-up). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01683903, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2012.

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