Ventilation therapy supports heart functioning in obese people with respiratory failure

Not Applicable

Completed

• Conditions: Obesity hypoventilation syndrome, chronic hypercapnic respiratory failure; Respiratory

• Registration Number: ISRCTN16950250
• Lead Sponsor: niversity of Pavol Jozef Šafárik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-11-15
• Study Start: 2024-07-18
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Clinically stable patients with OHS and severe hypercapnia during the daytime
2. Referred to the tertiary clinic for the initiation of long-term NIV to alleviate chronic respiratory failure

Exclusion Criteria

1. Inability to provide written informed consent
2. Neuromuscular, chest wall, or metabolic disease resulting in hypercapnia
3. Acute respiratory tract infection
4. Chronic obstructive pulmonary disease (COPD)
5. Systolic LV failure as evidenced by LV ejection fraction <45% on transthoracic echocardiography

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac output (in litres per minute), stroke volume (in milliliters), and heart rate (in beats per minute) measured by impedance cardiography (ICG) at baseline, and after 3 and 12 months of using noninvasive ventilation for treatment of chronic respiratory failure

Secondary Outcome Measures

Name	Time	Method
Biochemical markers analysed in venous blood: serum troponin 1 (pg/ml), N-terminal pro-B-type natriuretic peptide (pg/ml), tumor necrosis factor-alpha (pg/ml), and interleukin-6 (pg/ml), measured at baseline, and after 3 and 12 months of using non-invasive ventilation for treatment of chronic respiratory failure