Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF)

University of Pittsburgh

Status and phase: Completed; Phase 2

Conditions: Pulmonary Hypertension Secondary; Heart Failure

Treatments: Drug: Sodium Nitrite; Drug: Placebo Oral Capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03015402

5P01HL103455 (U.S. NIH Grant/Contract)

STUDY20010014

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

33 participants in 2 patient groups, including a placebo group

Sodium Nitrite

Experimental group

Description:

Study

Treatment:

Drug: Sodium Nitrite

Placebo

Placebo Comparator group

Description:

Control

Treatment:

Drug: Placebo Oral Capsule