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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT06331208
Eligibility Criteria:
A) Inclusion Criteria
HF group:
* age\>18y
* signed informed consent,
* left ventricular (LV) ejection fraction \<50%
* duration of HF\>6 months,
* loop diuretic use,
* clinical indication to right heart catheterisation
Control group:
* Age \>18years
* Signed informed consent
* Non-HF subjects referred to Institute for Clinical and Experimental Medicine (IKEM) in Prague for an invasive procedure (PFO closure, arrhythmia ablation, for subjects undergoing RHC) or non-invasive diagnostic evaluation (controls without invasive sampling)
B) Exclusion Criteria:
Heart Failure group:
* Patients with hemodynamic instability requiring inotropic support
* Severe renal insufficiency (estimated glomerular filtration rate \<0.6 ml/s)
* Acute coronary syndrome
* High cardiac output (cardiac index \>4 l/m2)
* Known pulmonary hypertension of other type than II (type I, III, IV)
* Active infection
* Respiration insufficiency
* Large pleural effusion
* Severe intrinsic lung disease (treated chronic obstructive pulmonary disease (COPD)
* asthma, known interstitial lung disease)
Control group:
* Pulmonary hypertension (RV systolic pressure estimate on screening \> 45 mmHg)
* History of recent pulmonary embolism \< 1 year
* Echocardiographic evidence of reduced function of right or left ventricle
* Treated asthma/COPD, known intersticial lung disease
* Significant exercise intolerance (NYHA \> II)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06331208
Study Brief:
Protocol Section:
NCT06331208