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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2023-01-25

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Pulmonary Hypertension Secondary Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sodium Nitrite

Study

Group Type EXPERIMENTAL

Sodium Nitrite

Intervention Type DRUG

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

Placebo

Control

Group Type PLACEBO_COMPARATOR

Placebo Oral Capsule

Intervention Type 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

Interventions

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Sodium Nitrite

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

Intervention Type DRUG

Placebo Oral Capsule

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

Intervention Type DRUG

Other Intervention Names

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study control

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No