Breathing Support for Heart Failure

Overseen By Jessica N Alcala, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: PDE5 inhibitors

Disqualifiers: Atrial fibrillation, Severe COPD, CKD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether different gas mixtures can help people with heart failure and obesity breathe better during exercise. Participants will breathe a helium-oxygen (HeO2) mixture and regular room air on separate days to determine which improves exercise capacity and reduces shortness of breath. It is open to individuals with signs of heart failure and a history of breathing problems during physical activity. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance exercise tolerance and quality of life for individuals with similar conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using phosphodiesterase type 5 (PDE5) inhibitors.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that helium-oxygen gas mixtures, known as heliox, are very safe. They have long been used to assist with various breathing problems. Studies have found that heliox is an inert gas, meaning it doesn't react with the body and has no biological effects, making it safe for use.

Heliox is particularly effective in reducing airway resistance, which helps air move in and out of the lungs more easily. This is beneficial for individuals with breathing difficulties. Past studies demonstrated that heliox was used safely even in very sick patients, indicating it is well-tolerated.

For those considering this treatment, evidence suggests it is safe and has a strong history of being well-tolerated in various situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Breathing Support for Heart Failure trial because it explores the potential of a HeO2 gas mixture as a unique way to support patients with heart failure. Unlike traditional treatments such as medications or devices that primarily focus on improving heart function, the HeO2 mixture involves breathing a blend of helium and oxygen. This mixture is lighter than regular air, which can make breathing easier and potentially reduce the workload on the heart. The trial's cross-over design, where participants experience both the HeO2 and room air mixtures on different days, helps to directly compare the effects and benefits of this innovative approach.

What evidence suggests that this trial's treatments could be effective for heart failure?

This trial will compare the effects of the HeO2 gas mixture with the room air gas mixture in heart failure patients. Studies have shown that the HeO2 gas mixture can aid individuals with breathing problems like asthma and COPD by easing airflow in and out of the lungs. Research also suggests that this gas mixture might reduce airway swelling. Although specific data on HeO2 for heart failure patients with obesity is limited, its success in other respiratory issues suggests it might also assist these patients with exercise and breathing difficulties. ^{2 3 6 7 8}

Who Is on the Research Team?

Tony G Babb, Ph.D.

Principal Investigator

UT Southwestern Medical Center

Bryce N Balmain, Ph.D.

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 55 with heart failure, specifically HFpEF, and obesity but not extremely overweight (BMI <50 kg/m2). Participants should have symptoms of heart failure, preserved ejection fraction (>0.50), diastolic dysfunction evidence, elevated NT-proBNP levels or a history of hospitalization due to heart failure. Healthy volunteers can also join. Exclusions include severe lung or valve disease, advanced kidney disease (CKD 4+), uncontrolled atrial fibrillation, PDE5 inhibitor use, and mobility issues.

Inclusion Criteria

Your heart's ejection fraction is higher than 50%.

There are signs that your heart is not relaxing properly between beats.

I am experiencing symptoms of heart failure.

Exclusion Criteria

I have a serious heart valve problem.

I have difficulty moving around.

I am taking medication for erectile dysfunction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Observational

Cross-sectional study to test the interaction of HFpEF and obesity on the O2 cost of breathing, and its association with DOE and peak exercise capacity

1 day

1 visit (in-person)

Interventional

Single-blind, randomized, placebo-controlled, cross-over trial to investigate the effects of HeO2 gas mixture on DOE and peak exercise capacity

2 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HeO2 gas mixture
• Room air gas mixture

Trial Overview The study aims to see if breathing limitations affect shortness of breath during exercise and peak exercise ability in patients with HFpEF and obesity by using two different gas mixtures: regular room air versus a helium-oxygen mixture (HeO2).

How Is the Trial Designed?

Group I: Room air gas mixture, then HeO2 gas mixture Experimental Treatment 2 Interventions

Participant will be randomized to each intervention on separate days (Study visit 3 and 4) in this cross-over trial. Participants that receive Room air first will then receive the HeO2 mixture. At least 24 hours will separate each visit.

Group II: HeO2 gas mixture, then Room air gas mixture Experimental Treatment 2 Interventions

Participant will be randomized to each intervention on separate days (Study visit 3 and 4) in this cross-over trial. Participants that receive HeO2 first will then receive the room air gas mixture. At least 24 hours will separate each visit.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

Helium-oxygen mixtures (heliox) are considered very safe for use in patients with severe airway obstruction, as no adverse effects have been reported, but they require careful monitoring to prevent technical complications.

Current literature lacks definitive randomized studies on the efficacy of heliox for mechanically ventilated patients, with mixed evidence regarding its benefits, highlighting the need for clinical teams to assess the risk/benefit ratio for each patient individually.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory controversies in the critical care setting. Should heliox be used for mechanically ventilated patients? Hurford, WE., Cheifetz, IM.[2017]

In a case study of a 23-year-old woman with severe asthma and tracheal angioedema, inhaling a helium-oxygen mixture (He-O2) led to rapid clinical improvement and increased oxygen saturation from 91% to 98%, avoiding the need for intubation.

He-O2 may serve as a safe and effective noninvasive treatment for acute upper airway obstruction, providing immediate relief with minimal adverse effects, although careful monitoring is recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using helium-oxygen mixtures in the emergency management of acute upper airway obstruction. Boorstein, JM., Boorstein, SM., Humphries, GN., et al.[2019]

Helium-oxygen (heliox) therapy significantly improved ventilation in patients with acute severe asthma and respiratory acidosis, as shown by a decrease in carbon dioxide levels (PaCO2) and an increase in arterial pH after treatment.

The therapy was particularly effective for patients who had a shorter duration of symptoms, with 67% of patients responding positively to heliox, while those with longer symptom durations were less likely to respond and some required intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heliox therapy in acute severe asthma. Kass, JE., Castriotta, RJ.[2019]

Helium-oxygen gas mixtures (heliox) are particularly effective in managing pediatric respiratory diseases that involve increased airway resistance, such as asthma and croup, especially when administered early in the disease process.

Heliox has been shown to relieve respiratory distress and improve gas exchange without reported adverse effects, although careful monitoring is necessary to prevent technical complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heliox administration in the pediatric intensive care unit: an evidence-based review. Gupta, VK., Cheifetz, IM.[2015]

Heliox, a mixture of helium and oxygen, can significantly improve breathing efficiency and reduce the work of breathing in patients with obstructive lung diseases, such as severe asthma and chronic obstructive pulmonary disease (COPD).

Although Heliox has shown beneficial effects in various clinical settings, including upper airway obstruction and bronchiolitis, its routine use is debated due to technical challenges and high costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical use of Heliox in asthma and COPD. Valli, G., Paoletti, P., Savi, D., et al.[2022]

In a Phase II trial with 12 lung cancer patients, breathing Heliox28 (72% Helium, 28% Oxygen) significantly improved oxygen saturation (SaO2) at rest compared to oxygen-enriched air, indicating better respiratory efficiency.

Heliox28 also enhanced exercise capability and reduced dyspnoea scores during 6-minute walk tests compared to medical air, suggesting it may be a beneficial treatment for patients experiencing breathlessness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, randomised, controlled Phase II trial of Heliox28 gas mixture in lung cancer patients with dyspnoea on exertion. Ahmedzai, SH., Laude, E., Robertson, A., et al.[2022]

In a study involving four patients with severe asthma and low oxygen levels, breathing a helium-oxygen (He-O2) mixture for 4 hours led to rapid clinical improvement and normalization of blood gas levels.

The He-O2 mixture works by reducing pulmonary resistance and enhancing overall alveolar ventilation, making it an effective intervention for patients experiencing alveolar hypoventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of helium and oxygen mixtures in status asthmaticus]. Martin-Barbaz, F., Barnoud, D., Carpentier, F., et al.[2013]

The He/O2 gas mixture can significantly improve breathing dynamics in patients with obstructive airway diseases, such as asthma and COPD, by increasing airflow and reducing work of breathing, but these effects are temporary and do not treat the underlying cause of obstruction.

While He/O2 ventilation shows promise in providing short-term relief for patients with severe respiratory conditions, there is currently no evidence that it improves long-term patient outcomes, highlighting the need for further studies before it can be widely recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helium-oxygen ventilation. Jolliet, P., Tassaux, D.[2019]

Heliox, a mixture of helium and oxygen, can effectively reduce airway resistance in patients with obstructive pulmonary diseases like asthma and COPD, making it a useful treatment option in acute respiratory distress situations.

In a case involving an infant with severe respiratory distress due to coronavirus OC43 infection, heliox inhalation was successfully used to avoid the need for intubation, highlighting its potential in managing severe respiratory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of heliox delivered via high-flow nasal cannula to treat an infant with coronavirus-related respiratory infection and severe acute air-flow obstruction. Morgan, SE., Vukin, K., Mosakowski, S., et al.[2016]

In a study of 24 ICU patients, using a mixture of helium and oxygen (heliox) during mechanical ventilation led to improved carbon dioxide elimination and reduced respiratory rates, indicating better ventilation efficiency.

Heliox ventilation allowed for lower minute volume and peak pressures while maintaining effective gas exchange, suggesting it could be beneficial in lung-protective mechanical ventilation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heliox Improves Carbon Dioxide Removal during Lung Protective Mechanical Ventilation. Beurskens, CJ., Brevoord, D., Lagrand, WK., et al.[2020]

Helium-oxygen mixtures (heliox) showed a reduction in arterial PCO2 in patients with acute severe COPD, suggesting a potential benefit in reducing the work of breathing, but overall evidence remains limited.

In a study involving 47 patients, heliox did not significantly improve lung function measures (FEV1 and FVC) compared to air, although there was a small improvement in a specific lung function measure (FEF 25-75), indicating that more research is needed to determine the efficacy of heliox in treating COPD exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heliox for treatment of exacerbations of chronic obstructive pulmonary disease. Rodrigo, G., Pollack, C., Rodrigo, C., et al.[2020]

In a study involving seven patients with severe asthma (status asthmaticus) who were intubated, the use of a helium-oxygen mixture (60% helium, 40% oxygen) led to rapid improvements in airway pressures and resolution of respiratory acidosis without any adverse effects.

The effectiveness of the helium-oxygen mixture is attributed to helium's unique properties, such as low density and high diffusivity, which enhance ventilation and reduce resistance in the airways, making it a promising option for patients who do not respond to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helium-oxygen mixtures in intubated patients with status asthmaticus and respiratory acidosis. Gluck, EH., Onorato, DJ., Castriotta, R.[2019]

Citations

1. withpower.com withpower.com/trial/early-phase-1-respiratory-aspiration-3-2023-898ae

Breathing Support for Heart Failure The He/O2 gas mixture can significantly improve breathing dynamics in patients with obstructive airway diseases, such as asthma and COPD, by increasing airflow ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4093964/

The use of heliox in critical care - PMC - PubMed Central - NIH This paper reviews the medical use of helium oxygen mixture in obstructive airway disease in patients with croup, narrow endotracheal tubes (ETTs), ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12124710/

Progress in the clinical application of heliox - PMC The application of heliox provides a novel therapeutic approach. Existing evidence shows that it can have anti-inflammatory effects and reduce I/R. However, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02373683?term=HELIUM%20AND%20OXYGEN&rank=9

Helium-oxygen Gas Mixtures Delivered by a High Flow ... The aim of this prospective pilot study is to determine the effect of heliox delivered via a proprietary calibrated heated and humidified high flow nasal ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0147956301343832

Safety and efficacy of heliox as a treatment for upper ... The mixture of helium and oxygen, called heliox, has been successfully used in the management of different respiratory diseases since 1935.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1794472/

Clinical review: Use of helium-oxygen in critically ill patients Breathing He/O 2 can benefit critically ill patients with severe respiratory compromise mainly by reducing airway resistance in obstructive syndromes.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0300957216301514

Helium ventilation for treatment of post-cardiac arrest ... We found that helium ventilation is feasible and can be used safely in patients treated with hypothermia after cardiac arrest.

8. researchgate.net researchgate.net/publication/391285442_Progress_in_the_clinical_application_of_heliox

(PDF) Progress in the clinical application of heliox Conclusion: Continuous heliox breathing does not appear to be cardioprotective in the setting of acute myocardial infarction in the rabbit model ...