NCT02254382

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 17, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

September 29, 2014

Last Update Submit

April 13, 2017

Conditions

Diastolic Heart Failure

Keywords

diastolic heart failure

Outcome Measures

Primary Outcomes (1)

  • Change in Apnea-Hypopnea-Index (AHI)

    6 months

Secondary Outcomes (24)

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

    6 months

  • Change in sleep quality determined by parameters of polysomnography

    6 months

  • Change in sleep efficacy determined by parameters of polysomnography

    6 months

  • Change of echocardiographic parameter of diastolic left ventricular ejection fraction function E/è

    6 months

  • Change of echocardiographic parameters of diastolic function

    6 months

  • +19 more secondary outcomes

Study Arms (1)

Adaptive servo ventilation (ASV)

EXPERIMENTAL

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

Device: Adaptive servo ventilation (ASV)

Interventions

Adaptive servo ventilation (ASV)DEVICE

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

Also known as: AutoSet CS
Adaptive servo ventilation (ASV)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Heart and Diabetes Centre

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Study Officials

  • Olaf Oldenburg, MD

    Herz- und Diabeteszentrum NRW, Bad Oeynhausen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 1, 2014

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 17, 2017

Record last verified: 2017-04

Locations

DE(2)