Pulmonary Hypertension SecondaryPhase 2PH-HFpEFNCT03015402
Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
A Phase 2 study testing Sodium Nitrite in people with Pulmonary Hypertension Secondary and Heart Failure, run by University of Pittsburgh at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension Secondary, Heart Failure
- What is being tested?
- Sodium Nitrite
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 25 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%;
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Phase II Clinical Investigation of Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
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).
Read the 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.
- Conditions
- Pulmonary Hypertension Secondary, Heart Failure
- Being tested
- Sodium Nitrite, Placebo Oral Capsule
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium NitriteDrug
Also called study
40 mg PO (by mouth) TID (three times each day) for 10 weeks
Placebo Oral CapsuleDrug
Also called control
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
| Study group | Role | What they receive |
|---|---|---|
| Sodium Nitrite | Experimental | Study Receives: Drug: Sodium Nitrite |
| Placebo | Placebo comparator | Control Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 10 weeks
Secondary outcomes (8)
Difference in 6-minute Walk Test
The 6-minute walk test measures the distance an individual is able to walk over 6 minutes on a hard, flat surface. The subject is allowed to self-pace and rest as needed.
The number of subjects with available 6-minute walk tests do not match the total number of subjects in the study due to: one subject fracturing a foot and several subjects missing visit timepoints due to health issues resulting in 6 minute walk test not being performed.
Measured: Baseline to 10 weeks
Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Capillary Wedge Pressure
Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Pulmonary Capillary Wedge Pressure are improved over the course of treatment.
Measured: During Week 10 follow-up at rest and at exercise
Change in Severity of Heart Failure
Determined by N-terminal pro b-type natriuretic peptide (NT-proBNP) plasma levels.
The number of subjects with available NT-proBNP values do not match the total number in the study as several subjects missed visit timepoints due to health issues resulting in NT-proBNP not being obtained.
Measured: Baseline to Week 10
Change in Right Heart Catheterization (RHC) Hemodynamics - Trans Pulmonary Gradient
Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Trans Pulmonary Gradient are improved over the course of treatment.
Measured: During Week 10 follow-up at rest and at exercise
Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Vascular Resistance
Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Pulmonary Vascular Resistance are improved over the course of treatment.
Measured: During Week 10 follow-up at rest and at exercise
Change in Right Heart Catheterization (RHC) Hemodynamics - Cardiac Output
Right heart catheterization hemodynamic measures will be aggregated to determine if overall hemodynamic on Cardiac Output are improved over the course of treatment.
Measured: During Week 10 follow-up at rest and at exercise
Number of Participants With Different Severities of Heart Failure
Determined by NYHA functional classification changes. Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m). Comfortable only at rest.
Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
While the change in severity of heart failure is listed as an end point, since this is ordinal data we cannot provide a p-value. We present the NYHA data at screening, crossover and 10 weeks.
Measured: 10 weeks
Change in Endurance Exercise Time
The endurance exercise time will be measured from the start of loaded pedaling to volitional exhaustion and the worklaod has returned to unloaded pedaling.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study start30 Oct 2017
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Hypertension SecondaryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Michael Risbano, University of Pittsburgh
- Investigators
- Michael Risbano, MD, MA, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015402
- Sponsor's protocol ID
- STUDY20010014
- Other IDs
- 5P01HL103455
- Acronym
- PH-HFpEF
- Status last verified
- Jun 2024
- First submitted
- 5 Jan 2017
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Investigation of Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
- ClinicalTrials.gov ID
- NCT03015402
- Acronym / sponsor ID
- PH-HFpEF / STUDY20010014
- Conditions
- Pulmonary Hypertension Secondary, Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Posted 7 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Nitrite | Experimental | Drug: Sodium NitriteStudy |
| Placebo | Placebo comparator | Drug: Placebo Oral CapsuleControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years and older
- Mean Pulmonary Arterial Pressure (mPAP) ≥ 25 mmHg AND
- Pulmonary capillary wedge pressure (PWCP) ≥ 15 mmHg AND
- Transpulmonary Gradient (TPG) ≥ 12 mmHg
Key exclusion criteria (15 listed)
- Age less than 18 years;
- SBP > 170 or < 110 mmHg
- DBP >95 or < 60 mmHg
- Hemoglobin A1C > 10
- Positive urine pregnancy test or breastfeeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium NitriteAlso: study40 mg PO (by mouth) TID (three times each day) for 10 weeks | Drug | Sodium Nitrite |
| Placebo Oral CapsuleAlso: controlPlacebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) TID (three times each day) for 10 weeks | Drug | Placebo |
Primary outcome
Mean Pulmonary Artery Pressure (mPAP) During Submaximal Exercise as Compared Between Placebo and Nitrite
Time frame: Baseline and 10 weeks
Mean Pulmonary Artery Pressure measurement at submaximal exercise as compared between Placebo and Oral Nitrite at 10 weeks.
8 secondary outcomes
Difference in 6-minute Walk Test
Time frame: Baseline to 10 weeks
Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Capillary Wedge Pressure
Time frame: During Week 10 follow-up at rest and at exercise
Change in Severity of Heart Failure
Time frame: Baseline to Week 10
Change in Right Heart Catheterization (RHC) Hemodynamics - Trans Pulmonary Gradient
Time frame: During Week 10 follow-up at rest and at exercise
Change in Right Heart Catheterization (RHC) Hemodynamics - Pulmonary Vascular Resistance
Time frame: During Week 10 follow-up at rest and at exercise
Change in Right Heart Catheterization (RHC) Hemodynamics - Cardiac Output
Time frame: During Week 10 follow-up at rest and at exercise
Number of Participants With Different Severities of Heart Failure
Time frame: 10 weeks
Change in Endurance Exercise Time
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Risbano, MD, MA principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Nitrite in people with Pulmonary Hypertension Secondary and Heart Failure, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Pulmonary Artery Pressure (mPAP) During Submaximal Exercise as Compared Between Placebo and Nitrite (time frame: Baseline and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.