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

ResMed

Status: Terminated

Conditions: Diastolic Heart Failure

Treatments: Device: Adaptive servo ventilation (ASV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02254382

MA130514

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Adaptive servo ventilation (ASV)

Experimental group

Description:

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

Treatment:

Device: Adaptive servo ventilation (ASV)