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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT04835194
Eligibility Criteria:
Inclusion Criteria:
* Male or female, at least 18 years at screening
* Preexisting or newly diagnosed hypertension, diabetes
* Preexisting or newly diagnosed heart failure with preserved ejection fraction using 2016 European Society of Cardiology's guideline on heart failure.
* Signs and symptoms of heart failure
* N-terminal pro brain natriuretic peptide (NT-proBNP) ≥300 in acute setting, and ≥125 in chronic setting
* Echocardiography with left ventricular ejection fraction (LVEF) ≥50% and at least one of these following criteria:
* Structural changes indicated by either left ventricle (LV) hypertrophy (any of the following: intraventricular septal or posterior wall thickness ≥1.1 cm, and/or LV mass index ≥115 g/m\*2 in male and ≥95 g/m\*2 in female), or left atrium (LA) enlargement (any of the following: left atrial volume (LAV) index ≥34 ml/m\*2, or or LA diameter \>40 mm)
* Further inclusion criteria apply
Exclusion Criteria:
* Listed for heart transplant
* Primary stage D valvular heart disease requiring surgery or intervention, prosthetic or mechanical valve.
* Severe, unrepaired pericardiac disease
* Complex, unrepaired congenital heart disease
* Takotsubo disease, peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, cardiac sarcoidosis/amyloidosis.
* End stage renal dysfunction, defined as persistent estimated glomerular filtration rate (eGFR)\<15 ml/min (CKD-EPI Chronic Kidney Disease Epidemiology Collaboration Equation) or requiring renal replacement therapy.
* Child-Pugh-Turcotte C.
* Life expectancy \<1 year due to non-cardiac etiology, as per investigator judgement
* Severe pulmonary disease requiring continuous home oxygen
* Pregnancy or lactation.
* Concurrent enrolment in another interventional device or drug trial
* Further exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04835194
Study Brief:
Protocol Section:
NCT04835194