- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07613762
High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation
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:
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Manuel A Gálvez, MSc
- 전화번호: +56 9 4229 3780
- 이메일: manuel.galvez.r@usach.cl
연구 장소
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, 칠레, 8380418
- Complejo Hospitalario San José
-
연락하다:
- Claudia Román, MPH
- 전화번호: 280019 +56225680000
- 이메일: claudia.roman@redsalud.gob.cl
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: HFNC (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.
|
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.
|
|
간섭 없음: No HFNC (Control)
Participants will perform an incremental treadmill test without any ventilatory support device.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Maximum treadmill test duration
기간: Immediately after each test session (up to 24 minutes)
|
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
기간: Immediately after each test session
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Heart rate
기간: Baseline and immediately after each test session
|
Heart rate measured in beats per minute using pulse oximetry
|
Baseline and immediately after each test session
|
|
Blood pressure
기간: Baseline and immediately after each test session
|
Systolic and diastolic blood pressure measured in mmHg using a sphygmomanometer
|
Baseline and immediately after each test session
|
|
Oxygen saturation
기간: Baseline and immediately after each test session
|
Peripheral oxygen saturation (SpO₂) measured as a percentage using pulse oximetry
|
Baseline and immediately after each test session
|
|
Respiratory rate
기간: Baseline and immediately after each test session
|
Respiratory rate measured in breaths per minute using a vital signs monitor
|
Baseline and immediately after each test session
|
|
Rate-pressure product
기간: Baseline and immediately after each test session
|
Calculated as systolic blood pressure multiplied by heart rate (mmHg × beats/min), used as an indirect indicator of myocardial oxygen demand
|
Baseline and immediately after each test session
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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
- 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.
- 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.
- Sociedad Chilena de Cardiología y Cirugía Vascular, Ministerio de Salud. Insuficiencia cardíaca. Santiago (Chile); 2015. 96 p.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NIC 23-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
심부전에 대한 임상 시험
-
Fondation Hôpital Saint-Joseph모병
-
Medical University of BialystokMedical University of Lodz; Poznan University of Medical Sciences; Nicolaus Copernicus University 그리고 다른 협력자들종료됨심부전, 수축기 | 박출률이 감소된 심부전 | 심부전 New York Heart Association Class IV | 심부전 New York Heart Association Class III폴란드
-
Novartis Pharmaceuticals완전한핵심 연구의 12개월 치료 기간을 성공적으로 완료한 환자(de Novo Heart Recipients)는 EC-MPS 치료에 관심이 있었습니다.
-
University of WashingtonAmerican Heart Association완전한심부전,울혈 | 미토콘드리아 변경 | 심부전 New York Heart Association Class IV미국
High-Flow Nasal Cannula (HFNC)에 대한 임상 시험
-
University Hospital, Antwerp완전한어린이 | 후두경 | 산소 요법벨기에
-
University of Maryland, BaltimoreVapotherm, Inc.완전한