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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad de Santiago de Chile

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: HFNC (Experimental)Experimental treatment 1 intervention
Group B: No HFNC (Control)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Maximum treadmill test duration

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

Time frame
Immediately after each test session (up to 24 minutes)
2

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

Time frame
Immediately after each test session

Secondary outcomes

1

Heart rate

Heart rate measured in beats per minute using pulse oximetry

Time frame
Baseline and immediately after each test session
2

Blood pressure

Systolic and diastolic blood pressure measured in mmHg using a sphygmomanometer

Time frame
Baseline and immediately after each test session
3

Oxygen saturation

Peripheral oxygen saturation (SpO₂) measured as a percentage using pulse oximetry

Time frame
Baseline and immediately after each test session
4

Respiratory rate

Respiratory rate measured in breaths per minute using a vital signs monitor

Time frame
Baseline and immediately after each test session

Other outcomes

Sponsors and contacts

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