Clinical trial NCT03015402: Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
Official title: Phase II Clinical Investigation of Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Hypertension Secondary
Heart Failure
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-01-10
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).

Detailed 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

Primary outcomes:
measure: Mean Pulmonary Artery Pressure (mPAP) During Submaximal Exercise as Compared Between Placebo and Nitrite
timeFrame: Baseline and 10 weeks
Secondary outcomes:
measure: Difference in 6-minute Walk Test
timeFrame: Baseline to 10 weeks
measure: Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Capillary Wedge Pressure
timeFrame: During Week 10 follow-up at rest and at exercise
measure: Change in Severity of Heart Failure
timeFrame: Baseline to Week 10
measure: Change in Right Heart Catheterization (RHC) Hemodynamics - Trans Pulmonary Gradient
timeFrame: During Week 10 follow-up at rest and at exercise
measure: Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Vascular Resistance
timeFrame: During Week 10 follow-up at rest and at exercise
measure: Change in Right Heart Catheterization (RHC) Hemodynamics - Cardiac Output
timeFrame: During Week 10 follow-up at rest and at exercise
measure: Number of Participants With Different Severities of Heart Failure
timeFrame: 10 weeks
measure: Change in Endurance Exercise Time
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Michael Risbano, MD, MA
role: PRINCIPAL_INVESTIGATOR
References: