Heart Failure Clinical Trial
Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
Summary
The main objective of this study is to determine the clinical efficacy of oral inorganic nitrite verses placebo and the therapeutic response with regards to exercise tolerance in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).
Full Description
This is a single-center, 22-week double-blind, randomized placebo-controlled cross-over trial of oral nitrite on exercise capacity and hemodynamic measurements in subjects with PH-HFpEF.
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
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There is 1 Location for this study
Pittsburgh Pennsylvania, 15213, United States
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