Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT02068118
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years or older
* Men or women patient with heart failure having been hospitalized for cardiac decompensation during the last 12 months.
* Patient with access to a wireline telephone service or GPRS network.
* The patient is willing and able to sign an informed written consent
* Patient is insured under the social security system
Exclusion Criteria:
* No available echocardiographic evaluation.
* BNP lower than 100pg/ml or NT-proBNP lower than 300pg/ml
* A prognosis of a life span of less than 12 months (apart from heart failure)
* Dialysis patients
* Heart transplant or cardiac assist devices
* Patients involved in inotropic treatment
* Patient doesn't have the necessary autonomy to use the equipment
* Patient enrolled in another clinical trial
* A pregnant or nursing woman, or patient of reproductive age who doesn't use contraceptives
* Patients under tutorship, curatorship or judicial protection
Inclusion Criteria in the extension period:
Participation in the open extension period is only offered to patients who participated in the comparative period of the study, did not withdraw prematurely from the latter and gave their free informed written consent to participate to the extension period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02068118
Study Brief:
Protocol Section:
NCT02068118