Breathing Exercise Against Dyspnoea in Heart Failure Patients to Improve Chemosensitivity

NCT05057884 | Suspended DMC

• 1 other identifier: Breathe-HF
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

An exaggerated ventilatory response (minute ventilation, V̇E) to exercise relative to exhaled carbon dioxide (V̇CO2) is common in heart failure (HF) patients with reduced as well as preserved left ventricular ejection fraction (HFrEF, HFpEF). Severity of this exaggerated response is associated with poor prognosis. This response may be triggered by pulmonary congestion and peripheral muscle myopathy. A vicious circle is fuelled by hypersensitivity of chemoreceptors to hypercapnia and sympathetic nervous hyperactivity, resulting in hyperventilation (low PaCO2). Low PaCO2 is predictive of mortality in these patients. PaCO2 can be increased acutely, e.g. by apnoea. Also, nasal breathing has been found to reduce the V̇E/V̇CO2 slope during exercise compared to oral breathing. Three previous slow breathing studies in HFrEF patients have had encouraging results with regard to reducing sympathetic activity, reflected in lowered arterial (pulmonary) blood pressure and increased EF. The investigators hypothesise that a 12-week training with nasal slow breathing followed by end-expiratory apnoea based on education, centre-based introduction and home-based 15 min/day breathing training will be effective at reducing the exaggerated ventilatory response to exercise. A total of 68 patients with stable HF seen at the HF clinics of the Inselspital (34 HFrEF, 34 HFpEF) will be randomised to the breathing intervention or usual care. Primary outcome will be V̇E/V̇CO2 slope at 12 weeks. If breathing training successfully ameliorates the exaggerated ventilatory response and perception of dyspnea during exercise, it offers an attractive tele-health based add-on therapy that may add to or even amplify the beneficial effects of exercise training.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Ventilation to carbon dioxide production slope

  Ventilation to carbon dioxide production (VE/VCO2) slope during ramp test

  Change from before to after 12-week breathing intervention

Secondary Outcomes (16)

• Nadir of ventilation to carbon dioxide production ratio

  Change from before to after 12-week breathing intervention

• Breathing frequency

  Change from before to after 12-week breathing intervention

• Pulmonary efficiency

  Change from before to after 12-week breathing intervention

• Aerobic capacity

  Change from before to after 12-week breathing intervention

• Resting end-tidal carbon dioxide

  Change from before to after 12-week breathing intervention

Study Arms (2)

Breathing training

EXPERIMENTAL

The respiratory pattern modulation training is performed at home for 12 weeks twice daily for 15 min per session and consists of three components: 1) education on abnormal ventilation in heart failure, the effect of ventilation on PaCO2 and the autonomous nervous system, and chemoreceptor sensitivity; 2) 1-3 sessions of guided and monitored face-to-face training with slow nasal abdominal breathing and intermittent apnoea supported by the Healer vest (L.I.F.E., Milan, Italy) measuring electrocardiogram (ECG), and chest excursions at the level of the xiphoid, thoracic manubrium, and abdomen; 3) independent home-based apnoea training supported by hand-outs, videos and weekly phone calls to monitor progress and adherence, answer questions and encourage further progression with duration of breath-hold.

Behavioral: Breathing training

Control

NO INTERVENTION

The control group receives standard of care. They perform the study measurements before and after the intervention period of 12 weeks. They are offered to perform the breathing training after study completion.

Interventions

Breathing training BEHAVIORAL

Slow nasal breathing with intermittent end-expiratory apnoea for 15 min twice per day over 12 weeks.

Breathing training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New York Heart Association (NYHA) functional classes II and III
• LVEF either \<50% or ≥50%
• V̇E/V̇CO2 slope ≥36, and/or a pattern of exercise oscillatory ventilation defined by established criteria
• Optimal guideline-directed medical therapy for \>3 months
• Written informed consent

You may not qualify if:

• Heart failure decompensation within the preceding 3 months
• Non-cardiac conditions and comorbidities associated with hyperventilation like pulmonary diseases
• Inability or unwillingness to perform apnoea training

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Preventive Cardiology and Sports Medicine, Bern University Hospital, Inselspital

Bern, 3010, Switzerland

Location

Related Publications (1)

• Eser P, Kaesermann D, Calamai P, Kalberer A, Stutz L, Huber S, Duffin J, Wilhelm M. Excess ventilation and chemosensitivity in patients with inefficient ventilation and chronic coronary syndrome or heart failure: a case-control study. Front Physiol. 2025 Jan 22;15:1509421. doi: 10.3389/fphys.2024.1509421. eCollection 2024.

  PMID: 39911179 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Matthias Wilhelm, Prof. MD

  Preventive Cardiology & Sports Medicine, Dept. of Cardiology, University Hospital Berne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 27, 2021
• Study Start: March 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)