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

Trial Summary

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.

What data supports the effectiveness of the treatment HeO2 gas mixture for heart failure?

Research shows that helium-oxygen mixtures can reduce the work of breathing and improve ventilation in patients with respiratory issues, such as asthma and COPD (chronic obstructive pulmonary disease). This suggests that HeO2 might help heart failure patients by easing breathing difficulties. ^{1 2 3 4 5}

Is the helium-oxygen gas mixture safe for use in humans?

Helium-oxygen gas mixtures, often called heliox, have been used for many years to treat various respiratory conditions and are considered extremely safe, with no reported adverse effects. However, they should be administered with careful monitoring to avoid technical complications. ^{1 6 7 8 9}

How is the HeO2 gas mixture treatment for heart failure different from other treatments?

The HeO2 gas mixture is unique because it uses a combination of helium and oxygen, which is less dense than regular air, to reduce breathing resistance and improve ventilation. This approach has been beneficial in other conditions like asthma and COPD, where it helps decrease the work of breathing and improve gas exchange, potentially offering a novel way to support heart failure patients with breathing difficulties. ^{1 4 10 11 12}

What is the purpose of this trial?

The overall purpose of this study is to investigate whether pulmonary limitations that increase the oxygen (O2) cost of breathing impact dyspnea on exertion (DOE) and peak exercise capacity in patients with HFpEF and obesity. As per investigator's hypothesis, obesity is likely a significant contributor to DOE and exercise intolerance in patients with HFpEF.

Research Team

Bryce N Balmain, Ph.D.

Principal Investigator

UT Southwestern Medical Center

Tony G Babb, Ph.D.

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Use of helium and oxygen mixtures in status asthmaticus]. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Helium-oxygen ventilation. [2019]

3. England 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Heliox for treatment of exacerbations of chronic obstructive pulmonary disease. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Helium-oxygen mixtures in intubated patients with status asthmaticus and respiratory acidosis. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Heliox therapy in acute severe asthma. [2019]

8. United States 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. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Heliox administration in the pediatric intensive care unit: an evidence-based review. [2015]

10. Egypt pubmed.ncbi.nlm.nih.gov

Heliox Improves Carbon Dioxide Removal during Lung Protective Mechanical Ventilation. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Using helium-oxygen mixtures in the emergency management of acute upper airway obstruction. [2019]

12. Italy pubmed.ncbi.nlm.nih.gov

Clinical use of Heliox in asthma and COPD. [2022]