High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation

NCT07613762 | Not Yet Recruiting

• 1 other identifier: NIC 23-2026
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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: 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.

Conditions

Heart Failure; Exercise Tolerance (Measured in Minutes); Cardiac Rehabilitation

Keywords

High-Flow Nasal Cannula; HFNC; Heart Failure; Cardiac Rehabilitation; Exercise Tolerance; Incremental Treadmill Test; Crossover Trial; Dyspnea; Physical Performance; Cardiopulmonary Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Maximum treadmill test duration

  Maximum time achieved by the participant during the incremental treadmill test, measured in seconds

  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

  Immediately after each test session

Secondary Outcomes (5)

• Heart rate

  Baseline and immediately after each test session

• Blood pressure

  Baseline and immediately after each test session

• Oxygen saturation

  Baseline and immediately after each test session

• Respiratory rate

  Baseline and immediately after each test session

• Rate-pressure product

  Baseline and immediately after each test session

Study Arms (2)

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.

Device: High-Flow Nasal Cannula (HFNC)

No HFNC (Control)

NO INTERVENTION

Participants will perform an incremental treadmill test without any ventilatory support device.

Interventions

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.

HFNC (Experimental)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Santiago de Chile: lead

Study Sites (1)

Complejo Hospitalario San José

Santiago, Santiago Metropolitan, 8380418, Chile

Location

Related Publications (17)

• 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.

  PMID: 40622949 BACKGROUND

• Fang 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.

  PMID: 32355724 BACKGROUND

• Candia 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.

  PMID: 38202239 BACKGROUND

• Chua 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

  BACKGROUND

• 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.

  PMID: 27794485 BACKGROUND

• Gao 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

  BACKGROUND

• 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.

  PMID: 40584583 BACKGROUND

• Buchfuhrer 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.

  PMID: 6643191 BACKGROUND

• Morris 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.

  PMID: 38619757 BACKGROUND

• Bozkurt 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.

  PMID: 33736829 BACKGROUND

• Savarese 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.

  PMID: 35150240 BACKGROUND

• Sociedad Chilena de Cardiología y Cirugía Vascular, Ministerio de Salud. Insuficiencia cardíaca. Santiago (Chile); 2015. 96 p.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23877260 BACKGROUND

• Li 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.

  PMID: 34837553 BACKGROUND

• Dibben GO, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease: a meta-analysis. Eur Heart J. 2023 Feb 7;44(6):452-469. doi: 10.1093/eurheartj/ehac747.

  PMID: 36746187 BACKGROUND

• Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.

  PMID: 35363499 BACKGROUND

Related Links

• Universidad de Santiago de Chile - Sponsor institution

MeSH Terms

Conditions

Heart Failure; Dyspnea

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Manuel A Gálvez, MSc

CONTACT

+56 9 4229 3780; manuel.galvez.r@usach.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor and Clinical Researcher, Escuela de Kinesiología, Universidad de Santiago de Chile

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)