Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

NCT03015402 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: STUDY200100145P01HL103455
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Hypertension Secondary; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Mean Pulmonary Artery Pressure (mPAP) During Submaximal Exercise as Compared Between Placebo and Nitrite

  Mean Pulmonary Artery Pressure measurement at submaximal exercise as compared between Placebo and Oral Nitrite at 10 weeks.

  Baseline and 10 weeks

Secondary Outcomes (8)

• Difference in 6-minute Walk Test

  Baseline to 10 weeks

• Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Capillary Wedge Pressure

  During Week 10 follow-up at rest and at exercise

• Change in Severity of Heart Failure

  Baseline to Week 10

• Change in Right Heart Catheterization (RHC) Hemodynamics - Trans Pulmonary Gradient

  During Week 10 follow-up at rest and at exercise

• Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Vascular Resistance

  During Week 10 follow-up at rest and at exercise

Study Arms (2)

Sodium Nitrite

EXPERIMENTAL

Study

Drug: Sodium Nitrite

Placebo

PLACEBO COMPARATOR

Control

Drug: Placebo Oral Capsule

Interventions

Sodium Nitrite DRUG

40 mg PO (by mouth) TID (three times each day) for 10 weeks

Also known as: study

Sodium Nitrite

Placebo Oral Capsule DRUG

Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) TID (three times each day) for 10 weeks

Also known as: control

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Sodium Nitrite

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nitrites; Nitrous Acid; Nitrogen Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

This was a small clinical trial that under-enrolled due to the pandemic.

Results Point of Contact

• Title: Dr. Michael Risbano, Director of Advanced Cardiopulmonary Exercise Testing Program
• Organization: University of Pittsburgh

risbanomg@upmc.edu

412-692-2210

Study Officials

• Michael Risbano, MD, MA

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 10, 2017
• Study Start: October 30, 2017
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: June 7, 2024
• Results First Posted: June 7, 2024

Record last verified: 2024-06

Locations

US (1)