Non-invasive Ventilation in Patients With Cardiac Heart Failure

December 14, 2022 updated by: Guillermo A. Mazzucco, University of Gran Rosario

Is Non-invasive Ventilation Effective in Improving the Exercise Capacity in Patients With Cardiac Heart Failure?: A Randomized Controlled Trial

Patients with heart failure (HF) have a reduced exercise tolerance as the main result of the disease. This exercise intolerance is due to heart conditions, but also to dysfunction of the respiratory and peripheral muscles. Various factors such as chronic hypoxia, oxidative stress, nutritional depletion, peripheral muscle disuse, effects of medications, and sympathetic-vagal imbalance are major contributors to deconditioning. In this scenario, the use of non-invasive ventilatory support (NIV) arises as an adjunct to cardiac rehabilitation in the attempt to improve the functional capacity of patients, since NIV reduces work of breathing, improves oxygenation and increases lung compliance associated with improved ejection volume, due to increased intrathoracic pressure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The main objective is to evaluate whether the use of NIV during Constant Treadmill Load Tests (CTLT) enhances exercise performance in Cardiac Heart Failure (CHF) patients on a treadmill.

Each recruited patient will be evaluated on 4 occasions, with two different evaluations, an incremental test (IT) to find out the maximum aerobic speed reached and then, in randomized order, three CTLT at 85% of the maximum reached in the IT . Two of the three CTLT will be performed with the use of NIV, with PS (IPAP 10cmH2O and EPAP 5cmH2O) and CPAP (5cmH2O) mode, and the rest will be without the use of NIV. The main study variable will be the time tolerated on the treadmill during CTLT.

Participants will have 5 minutes to adapt to NIV, 5-minute warm-up at 50% and then will start with the CTLT at 85% of the maximum aerobic speed reached in the IT.

In total, each patient will be evaluated four times on four different visits.

Sample size: For the sample's calculation, the maximum time in CTLC was chosen as the main study variable because it is a sensitive measure to detect changes after interventions (both pharmacological and non-pharmacological) and widely used in clinical trials. A minimum difference to detect of 100 seconds from previous literature was determined. Taking this data into account, and using a level of α of 0.05, a 1-β power of 0.80, and an effect size of 0.8, the sample size calculation for a paired t-test investigators found that at least 12 participants are needed. The calculation was made using the Gpower 3.1.9.7 software.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • University of Gran Rosario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ejection fraction demonstrated by echocardiography ≤ 40% (in the last 12 months).
  • NYHA functional class I - III.
  • Clinical stability, defined as four weeks prior to the start of the study without hospitalizations.
  • Signed informed consent.
  • ≥ 18 years of age.

Exclusion Criteria:

  • Chronic obstructive pulmonary disease (COPD), unstable angina or significant arrhythmias.
  • Myocardial infarction in the last 3 months, primary valve disease and anemia (hemoglobin under 13 g/dl for men or 12 g/dl for women).
  • Patients who are smokers or ex-smokers of less than one year.
  • Patients with cognitive impairment that prevents the correct understanding of the evaluations.
  • Any neuromuscular or osteoarticular condition that limits test performance.
  • Refusal to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Constant Treadmill Load Test (CTLT) using non-invasive ventilation (NIV)
Exercise capacity testing using PS in HF patients
Device: Non-invasive Ventilation
Exercise capacity testing using the device
Other Names:
  • Noninvasive Ventilations
Experimental: Constant Treadmill Load Test (CTLT) using NIV
Exercise capacity testing using CPAP in HF patients
Device: Non-invasive Ventilation
Exercise capacity testing using the device
Other Names:
  • Noninvasive Ventilations
Active Comparator: Constant Treadmill Load Test (CTLT) without NIV
Exercise capacity testing without NIV in HF patients
Device: Non-invasive Ventilation
Exercise capacity testing using the device
Other Names:
  • Noninvasive Ventilations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in exercise tolerance
Time Frame: At the end of exercise
Change in Maximun Walking time tolerated in a Constant Treadmill Load Test (CTLT) in seconds on treadmill between PS, CPAP and WNIT
At the end of exercise

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Dyspnea
Time Frame: At the end of exercise
Degree of dyspnea will be determined by this validated scale with a result between 0 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum.
At the end of exercise
Change in Cardiac Rate
Time Frame: At the end of exercise
Difference in Cardiac Rate (beats per minute) using a pulse oximetry (Masimo Radical 7) and a heart rate monitor (Polar FT1) between PS, CPAP and WNIT
At the end of exercise
Change in Oxygen Saturation
Time Frame: At the end of exercise
Change in Oxygen Saturation using a pulse oximetry (Masimo Radical 7) between PS, CPAP and WNIT
At the end of exercise
Change in Global Comfort
Time Frame: At the end of exercise
Change in global comfort according to the device used with Visual Analogue Scale (VAS). The VAS is a 10 cm line with anchor statements on the left (very unpleasant) and on the right (very pleasant) 0-10cm.
At the end of exercise
Change in Lower Limbs Fatigue
Time Frame: At the end of exercise
Change in Lower limbs fatigue perception using the Modified Borg Scale (Degree of fatigue will be determined by this validated scale with a result between 0 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum.
At the end of exercise
Change in Blood Pressure
Time Frame: At the end of exercise
Change in Systolic and Dyastolic blood preassure in mmHg at the beginning and at the end.
At the end of exercise
Change in Recovery heart rate
Time Frame: At the end of exercise
Change in heart rate (beats per minute) in the first minute, in the second minute and in the third minute after the test, using pulse oximetry (Masimo Radical 7)
At the end of exercise
Change in the motive for stopping the test
Time Frame: At the end of exercise
Change in reason for stopping the test. A dichotomous question will be asked regarding the reason for stopping the test, whether it was due to dyspnea or lower limb fatigue.
At the end of exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Gran Rosario

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2022

Primary Completion (Actual)

December 5, 2022

Study Completion (Actual)

December 5, 2022

Study Registration Dates

First Submitted

June 15, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Estimate)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 344/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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