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:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT02807168
Eligibility Criteria:
Inclusion Criteria:
1. Patients who are discharged after hospitalizations for AHF which is defined by:
* Dyspnea at rest or with minimal effort
* Pulmonary congestion on chest X ray
* NT-pro-BNP levels in the first 24 hours after admission:
\<50 years: \>450 pg/ml 50-75 years: \>900 pg/mL \>75 years: \>1800 pg/mL
2. -Administration of at least 40 mg IV furosemide (or equivalent) at admission
3. -Preserved ejection fraction (LVEF\>50%) in echocardiography performed at admission and evidence of diastolic dysfunction defined according to following parameters
* e´ \<8 cm/s septal or \<10 cm/s lateral (TDI mitral annulus)
* E/e' ratio \>15
* A mitral-A pulmon \> 30 msg
* Left atrial volumen index≥34 mL/m2
* left ventricular mass index \>95 g/m2 (woman) o \>115 g/m2 (man)
4. -Ability to sign the informed consent
Exclusion Criteria:
1. Significant lung disease demonstrated by spirometry
2. Life´s prognosis \< 6 months
3. Patients who does not have adhesion at the different visits of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02807168
Study Brief:
Protocol Section:
NCT02807168