Non-invasive Ventilation in Patients With Cardiac Heart Failure

NCT05433610 | Completed

• 1 other identifier: 344/2021
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Rehabilitation; Exercise Test; Heart Failure; Aerobic Exercise

Outcome Measures

Primary Outcomes (1)

• Change from baseline in exercise tolerance

  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 Outcomes (8)

• Change in Dyspnea

  At the end of exercise

• Change in Cardiac Rate

  At the end of exercise

• Change in Oxygen Saturation

  At the end of exercise

• Change in Global Comfort

  At the end of exercise

• Change in Lower Limbs Fatigue

  At the end of exercise

Study Arms (3)

Constant Treadmill Load Test (CTLT) using non-invasive ventilation (NIV)

EXPERIMENTAL

Exercise capacity testing using PS in HF patients

Device: Non-invasive Ventilation

Constant Treadmill Load Test (CTLT) using NIV

EXPERIMENTAL

Exercise capacity testing using CPAP in HF patients

Device: Non-invasive Ventilation

Constant Treadmill Load Test (CTLT) without NIV

ACTIVE COMPARATOR

Exercise capacity testing without NIV in HF patients

Device: Non-invasive Ventilation

Interventions

Non-invasive Ventilation DEVICE

Exercise capacity testing using the device

Also known as: Noninvasive Ventilations

Constant Treadmill Load Test (CTLT) using NIV; Constant Treadmill Load Test (CTLT) using non-invasive ventilation (NIV); Constant Treadmill Load Test (CTLT) without NIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Gran Rosario: lead

Study Sites (1)

University of Gran Rosario

Rosario, Santa Fe Province, 2000, Argentina

Location

Related Publications (5)

• O'Donnell DE, D'Arsigny C, Raj S, Abdollah H, Webb KA. Ventilatory assistance improves exercise endurance in stable congestive heart failure. Am J Respir Crit Care Med. 1999 Dec;160(6):1804-11. doi: 10.1164/ajrccm.160.6.9808134.

  PMID: 10588589 BACKGROUND

• Bittencourt HS, Reis HF, Lima MS, Gomes M Neto. Non-Invasive Ventilation in Patients with Heart Failure: A Systematic Review and Meta-Analysis. Arq Bras Cardiol. 2017 Feb;108(2):161-168. doi: 10.5935/abc.20170001. Epub 2017 Jan 16.

  PMID: 28099587 BACKGROUND

• Gosker HR, Wouters EF, van der Vusse GJ, Schols AM. Skeletal muscle dysfunction in chronic obstructive pulmonary disease and chronic heart failure: underlying mechanisms and therapy perspectives. Am J Clin Nutr. 2000 May;71(5):1033-47. doi: 10.1093/ajcn/71.5.1033.

  PMID: 10799364 BACKGROUND

• Borghi-Silva A, Carrascosa C, Oliveira CC, Barroco AC, Berton DC, Vilaca D, Lira-Filho EB, Ribeiro D, Nery LE, Neder JA. Effects of respiratory muscle unloading on leg muscle oxygenation and blood volume during high-intensity exercise in chronic heart failure. Am J Physiol Heart Circ Physiol. 2008 Jun;294(6):H2465-72. doi: 10.1152/ajpheart.91520.2007. Epub 2008 Mar 28.

  PMID: 18375714 BACKGROUND

• 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 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Interventional, crossover, randomized.

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 27, 2022
• Study Start: June 28, 2022
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

AR (1)