iNO for Hypertension

1
Effectiveness
2
Safety
Inova Heart and Lung Vascular Institute, Falls Church, VA
Hypertension+6 More
iNO - CombinationProduct
Eligibility
18+
All Sexes
Eligible conditions
Hypertension

Study Summary

This study is evaluating whether inhaled nitric oxide may help improve lung function in patients with pulmonary fibrosis and sarcoidosis.

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Eligible Conditions

  • Hypertension
  • Hypertension, Pulmonary
  • Pulmonary Fibrosis
  • Fibrosis
  • Sarcoidosis
  • Sarcoidosis, Pulmonary
  • Pulmonary Hypertension (PH)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether iNO will improve 5 primary outcomes and 7 secondary outcomes in patients with Hypertension. Measurement will happen over the course of During a single right heart catheterization procedure.

16 weeks
Change in 6MWD from Baseline to 16 Weeks
Distance Saturation Product (DSP)
Dyspnea
Integral Distance Saturation Product (IDSP)
Quality of Life Assessment
During a single right heart catheterization procedure
Incidence and Severity of Treatment Emergent Adverse Events
Measurement of CO
Measurement of PCWP
Measurement of PVR
Measurement of mean PAP
Pulmonary Rebound
Year 1
Incidence of Adverse Events and Serious Averse Events

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

Heart Transplant & LVAD Implantation With iNO
Venous Thromboemolic DVT
19%
All Cause Mortality
9%
New Onset Atrial Fibrillation
9%
Venous Thromboembolic Other
7%
Arterial Thromboembolic CVA/Stroke
6%
Venous Thromboembolic PE
4%
Upper GI Bleed
4%
Arterial Thromboembolic Other
3%
Lower GI Bleed
2%
Arterial Thromboembolic Mesenteric Ischemia
2%
Intestinal Perforation
1%
Arterial Thromboembolic TIA
1%
Arterial Thromboembolic Myocardial Infarction
1%
LVAD Thrombosis
1%
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT03081052) in the Heart Transplant & LVAD Implantation With iNO ARM group. Side effects include: Venous Thromboemolic DVT with 19%, All Cause Mortality with 9%, New Onset Atrial Fibrillation with 9%, Venous Thromboembolic Other with 7%, Arterial Thromboembolic CVA/Stroke with 6%.

Trial Design

2 Treatment Groups

No Control Group
PH-Pulmonary Fibrosis

This trial requires 17 total participants across 2 different treatment groups

This trial involves 2 different treatments. INO is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

PH-Pulmonary Fibrosis
CombinationProduct
Part 1: 1st 4 subjects will be treated with iNO 30, 45, 75 mcg/kg IBW/hr 2nd 4 subjects will be treated with iNO 45, 75, 125 mcg/kg IBW/hr Part 2: Optional open label long term extension at the optimal dose as identified in Part 1
PH-Sarcoidosis
CombinationProduct
Part 1: 1st 4 subjects will be treated with iNO 30, 45, 75 mcg/kg IBW/hr 2nd 4 subjects will be treated with iNO 45, 75, 125 mcg/kg IBW/hr Part 2: Optional Open label long term extension at the optimal dose as identified in Part 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iNO
2011
Completed Phase 4
~1350

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion; an average of 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion; an average of 1 year for reporting.

Closest Location

Inova Heart and Lung Vascular Institute - Falls Church, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Signed informed consent
Idiopathic pulmonary fibrosis
Idiopathic nonspecific interstitial pneumonia
Respiratory bronchiolitis-interstitial lung disease
Desquamative interstitial pneumonia
Cryptogenic organizing pneumonia
Acute interstitial pneumonia
Idiopathic lymphoid interstitial pneumonia
Idiopathic pleuroparenchymal fibroelastosis
Unclassifiable idiopathic interstitial pneumonias

Patient Q&A Section

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Other questions from users

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

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Hypertension by sharing your contact details with the study coordinator.