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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT04065620
Eligibility Criteria:
Inclusion Criteria:
* Patients with a previous diagnosis of HF-PEF, defined by:
* At least a previous hospitalization due to heart failure
* Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch, or within 6 months prior to study entry.
* Symptom(s) of heart failure (HF) and requiring, at least 30 days prior to study entry, hospitalization, or consultation to emergency room .
* Current symptom(s) of HF
* Structural heart disease documented by echocardiogram, namely septal or posterior wall thickness \>=1.1 cm) or LA enlargement (i.e., width \>=3.8 cm, length \>=5.0 cm, area \>=20 cm2, volume \>=55 ml, or volume index \>=29 ml/m
* Elevated NT-proBNP defined as NT-proBNP \>200 pg/ml if the patient had been hospitalized for HF within the past 9 months or \>300 pg/ml if not so.
Clinical and hemodynamic stability for at least 4 weeks before study inclusion, defined as stable treatment or functional class for at least 4 weeks before study inclusion, (changes in diuretic dosification are not considered as unstable treatment).
Exclusion Criteria:
* Any prior measurement of LVEF ≤ 40%.
* Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , urgent percutaneous coronary intervention or limb amputation due to peripheral arterial disease or Stroke within 3 months or and elective PCI within 30 days prior to entry.
* Current acute decompensated HF requiring therapy.
* Changes in antihypertensive treatment (class type or dose) 4 weeks before inclusion, excluding changes in diuretics due to congestion.
* Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, haemoglobin (Hgb) \<10 g/dl, or body mass index (BMI) \> 40 kg/m2.
* Systolic blood pressure (SBP) ≥ 180 mmHg or DBP ≥ 110 mmHg at entry.
* Patients with severe chronic renal disease, defined as GFR \<15 ml/min or haemodialysis.
* Inability to understand the study and participate voluntarily
* Patients diagnosed with cancer in the previous 12 months, and requiring treatment, at the time of study inclusion.
* Patients diagnosed with systemic autoimmune disease (lupus, vasculitis . . .)
* Patients not able to perform an ambulatory blood pressure measurement namely working at night, or patients with tachyarrhythmia.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
110 Years
Study:
NCT04065620
Study Brief:
Protocol Section:
NCT04065620