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 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT03344159
Eligibility Criteria:
Inclusion Criteria:
* Provide a personally signed and dated inform consent form.
* Male or female ≥ 18 years.
* Able to comply with all study procedures.
* History of right heart failure (RHF) secondary to either:
i) WHO, group 1 pulmonary arterial hypertension PAH OR ii) WHO group II PH with normal LV systolic function OR iii) WHO group III or IV PH OR iv) primary RV cardiomyopathy.
* Current NYHA II-IV
* RV dysfunction as measured by 2D echocardiogram:
i)defined as a tricuspid annular plane systolic excursion (TAPSE) \<16 mm ii) and /or a two dimensional fractional area change \<35% on screening echo plus
* NT-proBNP\>400 pg/ml
* Chronic use of diuretics
* Clinical stability: defined as no need for increased diuretics, hospitalization or emergency room visit 3 months prior to enrollment
Exclusion Criteria:
* Patients on chronic MRA therapy or other potassium sparing diuretics.
* Baseline serum potassium\>5 ummol/l.
* Estimated glomerular filtration rate \<30 ml/min.
* LV ejection fraction \<45%,
* Moderate or severe LV diastolic function,
* Moderate or severe aortic or valvular disease.
* Patients requiring augmentation of diuretics or otherwise not meeting definition for clinical stability.
* Severe Liver Failure (Child-Pugh Class C)
* Claustrophobia or inability lie still in a supine position
* Patients with contraindications to either PET or CMR imaging
* Pregnancy or lactation.
* Unable to provide consent and comply with follow up visits.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03344159
Study Brief:
Protocol Section:
NCT03344159