Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure

NCT ID: NCT02254382

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-03-31

Brief Summary

This is a multicenter, prospective, randomized clinical trial (pilot study). 20 participants with diastolic heart failure will be assigned to ventilation therapy (AutoSet CS ™ ASV device; therapy group). The trial will run for 6 months, after which change in echocardiographic parameters of diastolic left ventricular function, sleep and quality of life parameters will be evaluated.

Conditions

Diastolic Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adaptive servo ventilation (ASV)

This group will receive ventilation therapy (AutoSet CS, ASV device)

Group Type: EXPERIMENTAL

Adaptive servo ventilation (ASV)

Intervention Type: DEVICE

Non-invasive Ventilation used to control central and obstructive sleep apnea.

Interventions

Adaptive servo ventilation (ASV)

Non-invasive Ventilation used to control central and obstructive sleep apnea.

Intervention Type: DEVICE

Other Intervention Names

AutoSet CS

Eligibility Criteria

Inclusion Criteria

• Clinical signs and symptoms of heart failure according to the ESC guidelines
• Echocardiographic evidence of a preserved systolic left ventricular function (echocardiographic left ventricular ejection fraction > 50%)
• Polysomnographic evidence of at least moderate sleep-disordered breathing: apnea-hypopnea index (AHI) > 15 / h with ≥ 50% central events and with with a central AHI of ≥ 10/h (AHI based on total sleeping time, TST)
• BNP or NT-pro BNP ≥ 300 pg / ml
• NYHA class II or III
• Patient tolerates the ventilation treatment (1h sample ventilation)
• Stable drug therapy in the last 4 weeks prior to randomization (no iv diuretic therapy or increasing the dose of diuretics to ≥ 100%)
• Minimum age of patients of 18 years
• patient willing to undergo study procedures
• signed informed consent

Exclusion Criteria

• Oxygen saturation (sO2) <92% of the days in peace without O2 therapy, measured baseline (start time) in the pulse oximetry or polysomnography in a cape. BGA (the measurement must be max. Lie back 1 week)
• Patients, who have a risk professional with symptomatic sleep apnea
• Known COPD with FEV1 <70%
• patients with NYHA stadium IV
• Advanced congenital heart defects
• pericardial diseases
• Existing PAP or bi-level therapy (including adaptive servo-ventilation) in the last 3 months
• Acute cardiac event in the last 3 months
• BMI ≥ 35kg / m²
• Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olaf Oldenburg, MD

Role: PRINCIPAL_INVESTIGATOR

Herz- und Diabeteszentrum NRW, Bad Oeynhausen

Locations

University Hospital Regensburg

Regensburg, Bavaria, Germany

Heart and Diabetes Centre

Bad Oeynhausen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

MA130514

Identifier Type: -

Identifier Source: org_study_id