Sodium Nitrite for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Pittsburgh, Pittsburgh, PA
Heart Failure+3 More
Sodium Nitrite - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a chemical may help improve exercise tolerance for individuals with pulmonary hypertension and heart failure with preserved ejection fraction.

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Eligible Conditions

  • Heart Failure
  • Pulmonary Hypertension Secondary

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Sodium Nitrite will improve 1 primary outcome and 4 secondary outcomes in patients with Heart Failure. Measurement will happen over the course of 10 weeks (i.e. the 10th week of placebo vs 10th week of nitrite)..

Week 10
Change in endurance exercise time
Change in right heart catheterization (RHC) hemodynamics
Change in severity of heart failure
Difference in 6-minute walk test
Week 10
Pulmonary artery pressure (mPAP) during submaximal exercise as compared between placebo and nitrite

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Sodium Nitrite 160 mg/d
headache
25%
dizziness/light-headedness
17%
fatigue
17%
asymptomatic orthostatic hypotension
8%
nausea
0%
dry mouth
0%
This histogram enumerates side effects from a completed 2013 Phase 1 & 2 trial (NCT02022670) in the Sodium Nitrite 160 mg/d ARM group. Side effects include: headache with 25%, dizziness/light-headedness with 17%, fatigue with 17%, asymptomatic orthostatic hypotension with 8%, nausea with 0%.

Trial Design

2 Treatment Groups

Sodium Nitrite
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 21 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sodium Nitrite is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Sodium Nitrite
Drug
Placebo
Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitrous acid
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 weeks (i.e. the 10th week of placebo vs 10th week of nitrite)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 10 weeks (i.e. the 10th week of placebo vs 10th week of nitrite) for reporting.

Who is running the study

Principal Investigator
M. R.
Prof. Michael Risbano, Assistant Professor of Medicine
University of Pittsburgh

Closest Location

University of Pittsburgh - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18 years and older
Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mmHg
Pulmonary capillary wedge pressure (PWCP) ≥ 15 mmHg
Transpulmonary Gradient (TPG) ≥ 12 mmHg

Patient Q&A Section

What causes hypertension, pulmonary?

"The most probable cause is an inadequate blood flow. Hypertension is usually due to the vascular wall being stiff and thus resisting blood flow. This causes resistance, and in turn pressures, to increase in order to counterbalance the increase in resistance. A pulmonary arterial stenosis is the most probable condition that causes this." - Anonymous Online Contributor

Unverified Answer

Can hypertension, pulmonary be cured?

"The improvement in pulmonary hemodynamics and vascular pathophysiology is related to an improvement in heart function and pulmonary histological evaluation. The reduction in right heart pressure and pulmonary hypertension could allow patients to go out of hospital." - Anonymous Online Contributor

Unverified Answer

How many people get hypertension, pulmonary a year in the United States?

"The number of Americans who develop non-communicable diseases like hypertension, chronic obstructive pulmonary diseases, ispaht-associated pulmonary diseases, and various forms of cancer by the year 2030 is likely to increase if public health is not addressed immediately. If public health is not addressed, then there is a high possibility that the number of people with these chronic diseases in the United States may reach the levels of health problems caused by HIV/AIDS or other chronic lung diseases. The United States will then face a significant public health problem on a national level. At this point in the health care system, we can not afford to ignore the burden of chronic lung disease on the nation." - Anonymous Online Contributor

Unverified Answer

What are the signs of hypertension, pulmonary?

"The clinical features of hypertension are diverse. While there are many signs that can be noticed in general, some signs are very specific for this condition." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hypertension, pulmonary?

"Results from a recent clinical trial of research support the use of anti-hypertensive drugs. In some cases, beta blockers will be prescribed in the absence of first-line treatment. In case of resistance to conventional monotherapy, ACE inhibitors will be the therapeutic choice in addition to beta blockers. There are also non-pharmacological options like pulmonary rehabilitation to improve the quality of life of these patients." - Anonymous Online Contributor

Unverified Answer

What is hypertension, pulmonary?

"Patients with [pulmonary hypertension](https://www.withpower.com/clinical-trials/pulmonary-hypertension) usually experience right ventricular hypertrophy secondary to their hypertension, but occasionally develop left ventricular hypertrophy. Pulmonary hypertension also leads to decreased exercise capacity, fatigue, and shortness of breath. There is no one definitive test that determines a specific diagnosis. Treatment often entails treating hypertension, or some combination of medications and diuretics. Medications include beta blocker or prostacyclin in certain cases. These treatments can often help the pulmonary system, especially when combined with a diuretic such as furosemide. Occasionally, in some cases, surgery can be performed on the patient's lungs." - Anonymous Online Contributor

Unverified Answer

Does hypertension, pulmonary run in families?

"It appears that family history of hypertension and/or pulmonary hypertension (pulmonary vascular disease in some cases) is associated with an increased risk of death from cardiovascular causes in black individuals. Black individuals with a family history of hypertension (pulmonary hypertension in some cases) are particularly susceptible to the disease." - Anonymous Online Contributor

Unverified Answer

Is sodium nitrite safe for people?

"The data suggest that sodium nitrite may result in significant elevation of the blood pressure in people with hypertension. The data are of particular value in an environment of increasing hypertension-related health care utilization." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hypertension, pulmonary?

"Overall, hypertension occurs more commonly in older age groups, with a small rise occurring in the 6th, 9th, and 11th decades of life. Hypertension in persons of all ages can lead to long-term morbidity and disability with serious health consequences including heart failure and dementia." - Anonymous Online Contributor

Unverified Answer

Has sodium nitrite proven to be more effective than a placebo?

"The meta-analysis of this meta-analysis provides convincing evidence that the combination of sodium nitrite and simvastatin in an initial 4-week treatment has greater benefits than simvastatin alone." - Anonymous Online Contributor

Unverified Answer

What is sodium nitrite?

"Sodium nitrite may reduce the risk of pulmonary haemorrhagic events that could be prevented by pulmonary hypertension prophylaxis. It seems it does by improving the vasodilation and by protecting red blood cells against oxidative damage." - Anonymous Online Contributor

Unverified Answer

What is the latest research for hypertension, pulmonary?

"According to this investigation, there is no consensus regarding the most effective treatment of pulmonary arterial hypertension in a clinical context. The treatment of pulmonary arterial hypertension is highly complex and a rational approach that takes into account the severity and heterogeneity of the disease is necessary. The present study highlights the most up to date available data (new and old) supporting the use of different treatment combinations to improve the therapeutic efficacy of the treatment of pulmonary arterial hypertension in a clinical context." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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