Heart FailureNCT07613762
High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation
A study testing High-Flow Nasal Cannula (HFNC) in people with Heart Failure and Exercise Tolerance (Measured in Minutes), run by Universidad de Santiago de Chile at 1 site in Chile.
Trial summary
The goal of this clinical trial is to learn if a high-flow nasal cannula (HFNC) - a device that delivers warm, humidified air through a small tube placed in the nostrils - can improve exercise tolerance in adults with heart failure (HF) who are entering a cardiac rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Exercise Tolerance (Measured in Minutes), Cardiac Rehabilitation
- What is being tested?
- High-Flow Nasal Cannula (HFNC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2026to Mar 2027
- Phase
- Interventional
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 or older
- Medical diagnosis of heart failure (documented in clinical record or referral)
- Electrocardiogram performed within the last 6 months
- Functional capacity class II or III according to the New York Heart Association (NYHA) classification
- Stable pharmacological treatment
- Stable and controlled comorbidities
- Available to complete two evaluation sessions
- Able and willing to provide written informed consent
Who cannot join
- Diagnosis of respiratory disease (chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary hypertension)
- Myocardial infarction within the past 3 months
- Hospitalization due to heart failure within the past 4 weeks
- Cognitive impairment or inability to follow the study protocol
- Neuromuscular or osteoarticular conditions that limit treadmill test performance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Complejo Hospitalario San José
Santiago, Santiago Metropolitan, 8380418
Claudia Román, MPH, +56225680000 ext. 280019, claudia.roman@redsalud.gob.cl
About this study
Official title: Effect of High-Flow Nasal Cannula Use on Exercise Tolerance and Physical Performance in Heart Failure Patients Enrolled in a Cardiac Rehabilitation Program: A Randomized Crossover Trial
The goal of this clinical trial is to learn if a high-flow nasal cannula (HFNC) - a device that delivers warm, humidified air through a small tube placed in the nostrils - can improve exercise tolerance in adults with heart failure (HF) who are entering a cardiac rehabilitation program. The main questions it aims to answer are: Can HFNC help people with heart failure exercise for a longer time during a treadmill test? and does HFNC lower how hard people feel they are working during exercise?
Researchers will compare exercise performance with HFNC to exercise performance without HFNC to see if HFNC helps people with HF tolerate exercise better. Participants will:
Read more
Complete two treadmill exercise tests, one with HFNC and one without, in a randomly assigned order.
Wait 48 to 72 hours between the two tests to allow full recovery. Have their heart rate, blood pressure, oxygen level, and breathing rate measured before and after each test.
Read the detailed description
Heart failure is a chronic syndrome characterized by reduced cardiac output, exercise intolerance, and dyspnea. Despite the well-established benefits of cardiac rehabilitation, many HF patients have severely limited exercise capacity, which restricts the intensity and duration of training they can safely perform.
High-flow nasal cannula (HFNC) delivers heated, humidified air at flow rates of 50-60 L/min. Its physiological effects include reduction of inspiratory work, washout of nasopharyngeal dead space, generation of positive end-expiratory pressure, and improved mucociliary transport. These mechanisms may facilitate exercise in patients with cardiorespiratory limitations.
STUDY DESIGN. Randomized crossover trial. Each participant acts as their own control, completing two incremental treadmill tests in random order, separated by a washout period of 48-72 hours: Condition A (experimental): HFNC via AIRVO 2™ device (Fisher \& Paykel Healthcare) with asymmetric nasal cannula at 50-60 L/min, FiO₂ 0.21, temperature 34-37°C. Condition B (control): no ventilatory support device. Randomization will be performed using randomizer.org. Before the experimental condition, participants will undergo an acclimatization period in which flow is increased by 10 L/min every 5-10 minutes until reaching the target flow or maximum tolerated flow.
EXERCISE PROTOCOL. An incremental protocol will be used on the treadmill, which will consist of incline and a progressive increase in speed and grade. The test ends at voluntary exhaustion or when predefined safety stopping criteria are met.
SAFETY. The test will be stopped if any of the following occur: chest pain, severe dyspnea (Borg ≥8), nausea or presyncope, cyanosis, SpO₂ below 90%, or heart rate above 85% of age-predicted maximum. The testing site will be equipped with automated external defibrillator, bag-valve mask, emergency oxygen, and at least one team member certified in advanced life support. Direct transfer to the hospital emergency service is available on-site (Complejo Hospitalario San José).
OUTCOMES. Primary outcomes are maximum treadmill test duration (seconds) and perceived exertion (Modified Borg Scale, 0-10), measured immediately after each test. Secondary outcomes - blood pressure, heart rate, SpO₂, respiratory rate, and rate-pressure product - are measured at baseline and immediately post-test.
STATISTICAL ANALYSIS. Data normality will be assessed using the Shapiro-Wilk test (n<50). Paired t-test or Wilcoxon signed-rank test will be applied depending on data distribution. Sample size was calculated for a crossover design (two-tailed, α=0.05, power=80%, dz=0.8), yielding 23 participants; 28 will be recruited assuming 20% dropout.
CO-INVESTIGATORS: Monserrat Delgado Valverde, Monserrat Orellana Morales, Emily Quiñileo Riffo, and Sergio Silva Valverde (Escuala de Kinesiología, Universidad de Santiago de Chile). Claudia Román Ureta, Paulina Castro Olivares (Complejo Hospitalario San José).
SETTING. Cardiovascular rehabilitation program, Complejo Hospitalario San José, Independencia, Santiago, Chile.
- Being tested
- High-Flow Nasal Cannula (HFNC)
- Keywords
- High-Flow Nasal Cannula, HFNC, Heart Failure, Cardiac Rehabilitation, Exercise Tolerance, Incremental Treadmill Test, Crossover Trial, Dyspnea, Physical Performance, Cardiopulmonary Rehabilitation
- Medical subject headings
- Heart Failure, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Nasal Cannula (HFNC)Device
HFNC delivered via AIRVO 2™ (Fisher \& Paykel Healthcare, Auckland, New Zealand) with a nasal cannula at 50-60 L/min, FiO₂ 0.21, temperature 34-37°C. The cannula is removed immediately after the test is completed.
| Study group | Role | What they receive |
|---|---|---|
| HFNC (Experimental) | Experimental | Participants will perform an incremental treadmill test while using high-flow nasal cannula (HFNC) via AIRVO 2™ device with a nasal cannula at 50-60 L/min, FiO₂ 0.21, and temperature set at 34-37°C according to participant comfort. An acclimatization period will be performed before the test, increasing flow by 10 L/min every 5-10 minutes until reaching the target flow. Receives: Device: High-Flow Nasal Cannula (HFNC) |
| No HFNC (Control) | No intervention | Participants will perform an incremental treadmill test without any ventilatory support device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum treadmill test duration
Maximum time achieved by the participant during the incremental treadmill test, measured in seconds
Measured: Immediately after each test session (up to 24 minutes)
Perceived exertion
Participant's subjective perception of effort measured using the Modified Borg Scale (0-10), where 0 is nothing at all and 10 is extremely heavy
Measured: Immediately after each test session
Secondary outcomes (5)
Heart rate
Heart rate measured in beats per minute using pulse oximetry
Measured: Baseline and immediately after each test session
Blood pressure
Systolic and diastolic blood pressure measured in mmHg using a sphygmomanometer
Measured: Baseline and immediately after each test session
Oxygen saturation
Peripheral oxygen saturation (SpO₂) measured as a percentage using pulse oximetry
Measured: Baseline and immediately after each test session
Respiratory rate
Respiratory rate measured in breaths per minute using a vital signs monitor
Measured: Baseline and immediately after each test session
Rate-pressure product
Calculated as systolic blood pressure multiplied by heart rate (mmHg × beats/min), used as an indirect indicator of myocardial oxygen demand
Measured: Baseline and immediately after each test session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will complete both study conditions in a randomly assigned order, separated by a washout period of 48 to 72 hours to allow full physical recovery. Sequence allocation (HFNC → No HFNC, or No HFNC → HFNC) will be determined using randomizer.org prior to the first test session.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Santiago de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Gálvez Reyes, Universidad de Santiago de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613762
- Sponsor's protocol ID
- NIC 23-2026
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared during the study period. Data will be stored on a password-protected server at Universidad de Santiago de Chile for 5 years after study completion. Only anonymized data, with no information that could identify participants, may be deposited in a public repository after the custody period ends. Any future use of the data will require a specific and separate consent process.
Publications
Mazzucco G, Torres-Castro R, Intelangelo L, Lista-Paz A, Escalante JP, Zumeta-Olaskoaga L, Veiga G, Etxarri AA. Is non-invasive ventilation effective in improving the exercise capacity in patients with cardiac heart failure?: A randomised crossover trial. PLoS One. 2025 Jul 7;20(7):e0327399. doi: 10.1371/journal.pone.0327399. eCollection 2025.
PubMed 40622949Fang TP, Chen YH, Hsiao HF, Cho HY, Tsai YH, Huang CC, Hsieh MJ, Wu HP, Lin HL. Effect of high flow nasal cannula on peripheral muscle oxygenation and hemodynamic during paddling exercise in patients with chronic obstructive pulmonary disease: a randomized controlled trial. Ann Transl Med. 2020 Mar;8(6):280. doi: 10.21037/atm.2020.03.87.
PubMed 32355724Candia C, Lombardi C, Merola C, Ambrosino P, D'Anna SE, Vicario A, De Marco S, Molino A, Maniscalco M. The Role of High-Flow Nasal Cannula Oxygen Therapy in Exercise Testing and Pulmonary Rehabilitation: A Review of the Current Literature. J Clin Med. 2023 Dec 30;13(1):232. doi: 10.3390/jcm13010232.
PubMed 38202239Chua MT, Kuan WS. The use of high-flow nasal cannula in acute decompensated heart failure. J Emerg Crit Care Med. 2017;1:22. doi:10.21037/jeccm.2017.08.06
Carvalho LA, Brandao DC, Campos SL, Vidal TMS, Remigio MI, Martins SM, Dornelas de Andrade A. Noninvasive Ventilation Before Maximum Exercise Test Increases Exercise Tolerance in Subjects With Heart Failure: A Crossover Study. Arch Phys Med Rehabil. 2017 May;98(5):849-855. doi: 10.1016/j.apmr.2016.09.129. Epub 2016 Oct 26.
PubMed 27794485Gao H, Chen L, Kang X. High-flow nasal cannula oxygen therapy in patients with acute heart failure: a meta-analysis. J Nurse Pract. 2023;19(5):104602. doi:10.1016/j.nurpra.2023.104602
Tremblay-Gravel M, Nozza A, Glezer S, Kamada A, Boulet J, Parent MC, Giraldeau G, Racine N, Nigam A, Cloutier I, Pierre R, Rouleau JL, O'Meara E, Ducharme A, Tardif JC. Oxygen supplementation in ambulatory patients with heart failure: a randomized proof-of-concept study. Eur Heart J Open. 2025 Jun 11;5(3):oeaf074. doi: 10.1093/ehjopen/oeaf074. eCollection 2025 May.
PubMed 40584583Buchfuhrer MJ, Hansen JE, Robinson TE, Sue DY, Wasserman K, Whipp BJ. Optimizing the exercise protocol for cardiopulmonary assessment. J Appl Physiol Respir Environ Exerc Physiol. 1983 Nov;55(5):1558-64. doi: 10.1152/jappl.1983.55.5.1558.
PubMed 6643191Morris BA, Sinaei R, Smart NA. Resistance is not futile: a systematic review of the benefits, mechanisms and safety of resistance training in people with heart failure. Heart Fail Rev. 2024 Jul;29(4):827-839. doi: 10.1007/s10741-024-10402-0. Epub 2024 Apr 15.
PubMed 38619757Bozkurt B, Fonarow GC, Goldberg LR, Guglin M, Josephson RA, Forman DE, Lin G, Lindenfeld J, O'Connor C, Panjrath G, Pina IL, Shah T, Sinha SS, Wolfel E; ACC's Heart Failure and Transplant Section and Leadership Council. Cardiac Rehabilitation for Patients With Heart Failure: JACC Expert Panel. J Am Coll Cardiol. 2021 Mar 23;77(11):1454-1469. doi: 10.1016/j.jacc.2021.01.030.
PubMed 33736829Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023 Jan 18;118(17):3272-3287. doi: 10.1093/cvr/cvac013.
PubMed 35150240Sociedad Chilena de Cardiología y Cirugía Vascular, Ministerio de Salud. Insuficiencia cardíaca. Santiago (Chile); 2015. 96 p.
Dell'Era S, Roux N, Gimeno-Santos E, Terrasa S. The High Flow Nasal Cannula Improves the Exercise Capacity in Patients with COPD: Randomized, Crossover Clinical Trial. Rev Am Med Respir. 2019;19(1):16-26.
Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.
PubMed 23877260Li J, Scott JB, Fink JB, Reed B, Roca O, Dhand R. Optimizing high-flow nasal cannula flow settings in adult hypoxemic patients based on peak inspiratory flow during tidal breathing. Ann Intensive Care. 2021 Nov 27;11(1):164. doi: 10.1186/s13613-021-00949-8.
PubMed 34837553