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

Diastolic Heart Failure Clinical Trial

— ParadiseHF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02254382
• Other study ID #: MA130514
• Status: Terminated
• Phase: N/A
• First received: September 29, 2014
• Last updated: April 13, 2017
• Start date: March 2016
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diastolic Heart Failure
• Heart Failure
• Heart Failure, Diastolic

Intervention

Device:
• Adaptive servo ventilation (ASV)
Non-invasive Ventilation used to control central and obstructive sleep apnea.

Locations

Country	Name	City	State
Germany	Heart and Diabetes Centre	Bad Oeynhausen	North Rhine-Westphalia
Germany	University Hospital Regensburg	Regensburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Apnea-Hypopnea-Index (AHI)		6 months
Secondary	Change in total sleeping time (TST) determined by parameters of polysomnography	Total sleeping time (TST) will be measured in minutes (min).	6 months
Secondary	Change in sleep quality determined by parameters of polysomnography	Sleep Quality will be defined by sleep architecture (time spent in sleep Phase 1,2,3 and REM).	6 months
Secondary	Change in sleep efficacy determined by parameters of polysomnography	Sleep efficacy is defined as TST/total time spent in bed, i.e. sleep/awake periods.	6 months
Secondary	Change of echocardiographic parameter of diastolic left ventricular ejection fraction function E/è	E (mitral inflow velocity) and è (mitral annular early diastolic velocity) are parameters to measure filling of the left ventricle with blood.The E/è Ratio gives an estimation of the filling pressure of the left ventricle.	6 months
Secondary	Change of echocardiographic parameters of diastolic function		6 months
Secondary	Change of NYHA stage		6 months
Secondary	Change of nocturia		6 months
Secondary	Changes of questionnaires: ESS	ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime.	6 months
Secondary	Changes of questionnaires: MLHFQ	MLHFQ (Minnesota Living with Heart Failure) estimates how much HF impairs the daily life of a patient.	6 months
Secondary	Changes of questionnaires (PHQ9)	PHQ9 (Patient health questionnaire) assesses depression of a patient.	6 months
Secondary	Changes of questionnaires (SF12HSQ)	SF12HSQ (short form health status) assesses physical and mental health status.	6 months
Secondary	Change in NT-pro BNP and BNP	NT-pro BNP and BNP (unit ng/l) are comprehensive protein markers of heart diseases, inflammations and cardiovascular disorders. Outcome: Assessment of heart disease status.	6 months
Secondary	Changes in blood gas analysis		6 months
Secondary	Change of galactin-3		6 months
Secondary	Change in 6 minute walk test (MWT)		6 months
Secondary	Hospitalisations (reason)	Reasons will be described in the corresponding files: Type of disease: Treatment related or unrelated?	6 months
Secondary	Hospitalisations (cumulative length)	Length of hospitalizations are measured in days (d). Severity of disease.	6 months
Secondary	Change in morning blood pressure		6 months
Secondary	Change in morning heart rate		6 months
Secondary	Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE)		6 months
Secondary	Changes in parameters of cardiac repolarisation (QT(c), TpTe(c) intervals, TpTe/QT ratio) in ECG at rest	Electrocardiogram parameters are being put together to assess the patient`s heart function status. Outcome: Number of patients with normal heart function.	6 months
Secondary	Changes in occurrence of ventricular and supraventricular arrhythmias (PSG-ECG)	Parameters are being put together to assess the patient`s heart function status. Outcome: Number of patients with arrhythmias.	6 months
Secondary	Analysis of compliance data		6 months
Secondary	Changes in spiroergometry data (substudy)		6 months