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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT03015402
Eligibility Criteria:
Inclusion Criteria:
Age 18 years and older
PH-HFpEF confirmed diagnosis by RHC:
* Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mmHg AND
* Pulmonary capillary wedge pressure (PWCP) ≥ 15 mmHg AND
* Transpulmonary Gradient (TPG) ≥ 12 mmHg
Exclusion Criteria:
* Age less than 18 years;
* SBP \> 170 or \< 110 mmHg
* DBP \>95 or \< 60 mmHg
* Hemoglobin A1C \> 10
* Positive urine pregnancy test or breastfeeding;
* Ejection Fraction (EF) \< 40%;
* Dementia
* End-stage malignancy
* Major cardiovascular event or procedure within 6 weeks prior to enrollment
* Severe valvular disease
* Known chronic psychiatric or medical conditions that may increase the risk associated with study participation in the judgment of the investigator, would make the subject inappropriate for entry into this study;
* Smoker
* Hemoglobin \<9 g/dL
* Serum creatinine \> 3.0 mg/dL
* Receipt of an investigational product or device, or participation in a drug research study within a period of 15 days; RHC \< 2 weeks from study screening RHC unless clinically indicated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03015402
Study Brief:
Protocol Section:
NCT03015402