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Diastolic Heart FailureParadiseHFNCT02254382

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

A study testing Adaptive servo ventilation (ASV) in people with Diastolic Heart Failure, run by ResMed at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diastolic Heart Failure
What is being tested?
Adaptive servo ventilation (ASV)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
2 sitesGermany
Study dates
Mar 2016to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

2 sites in 1 country.

Germany2 sites

  • Heart and Diabetes Centre

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • University Hospital Regensburg

    Regensburg, Bavaria, 93053

Other trials in Germany

About this study

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.

Being tested
Adaptive servo ventilation (ASV)
Keywords
diastolic heart failure
Medical subject headings
Heart Failure, Diastolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adaptive servo ventilation (ASV)Device

    Also called AutoSet CS

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

Study groups in NCT02254382
Study groupRoleWhat they receive
Adaptive servo ventilation (ASV)ExperimentalThis group will receive ventilation therapy (AutoSet CS, ASV device)
Receives: Device: Adaptive servo ventilation (ASV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Apnea-Hypopnea-Index (AHI)

    Measured: 6 months

Secondary outcomes (24)

  1. Change in total sleeping time (TST) determined by parameters of polysomnography

    Total sleeping time (TST) will be measured in minutes (min).

    Measured: 6 months

  2. 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).

    Measured: 6 months

  3. 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.

    Measured: 6 months

  4. 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.

    Measured: 6 months

  5. Change of echocardiographic parameters of diastolic function

    Measured: 6 months

  6. Change of NYHA stage

    Measured: 6 months

  7. Change of nocturia

    Measured: 6 months

  8. Changes of questionnaires: ESS

    ESS (Epworth Sleepiness Scale) estimates the sleepiness of a person during daytime.

    Measured: 6 months

  9. Changes of questionnaires: MLHFQ

    MLHFQ (Minnesota Living with Heart Failure) estimates how much HF impairs the daily life of a patient.

    Measured: 6 months

  10. Changes of questionnaires (PHQ9)

    PHQ9 (Patient health questionnaire) assesses depression of a patient.

    Measured: 6 months

  11. Changes of questionnaires (SF12HSQ)

    SF12HSQ (short form health status) assesses physical and mental health status.

    Measured: 6 months

  12. 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.

    Measured: 6 months

  13. Changes in blood gas analysis

    Measured: 6 months

  14. Change of galactin-3

    Measured: 6 months

  15. Change in 6 minute walk test (MWT)

    Measured: 6 months

  16. Hospitalisations (reason)

    Reasons will be described in the corresponding files: Type of disease: Treatment related or unrelated?

    Measured: 6 months

  17. Hospitalisations (cumulative length)

    Length of hospitalizations are measured in days (d). Severity of disease.

    Measured: 6 months

  18. Change in morning blood pressure

    Measured: 6 months

  19. Change in morning heart rate

    Measured: 6 months

  20. Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE)

    Measured: 6 months

  21. 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.

    Measured: 6 months

  22. 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.

    Measured: 6 months

  23. Analysis of compliance data

    Measured: 6 months

  24. Changes in spiroergometry data (substudy)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2014 (estimated)
  2. Study startMar 2016
  3. Primary completionMar 2017
  4. Study completionMar 2017

Why it stopped: Recruitment rates too low

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02254382
Sponsor's protocol ID
MA130514
Acronym
ParadiseHF
Status last verified
Apr 2017
First submitted
29 Sep 2014
Last updated
17 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Adaptive servo ventilation (ASV) in people with Diastolic Heart Failure, run by ResMed at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recruitment rates too low). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Apnea-Hypopnea-Index (AHI) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02254382.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.

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