NCT01041924

Brief Summary

Normally breathing is controlled by a reflex that responds to the levels of carbon dioxide (CO2) in the blood. In heart failure, where the heart muscle is damaged and therefore does not pump as well, this reflex is exaggerated. The result is a vicious circle: blood CO2 levels fluctuate wildly and as a result breathing also fluctuates with patients hyperventilating at times and briefly stopping breathing at others. During sleep this is called central sleep apnoea (CSA). Patients with CSA wake up throughout the night and whilst some patients are oblivious to this, others are consciously breathless and many patients are tired during the day and feel unable to perform their daily activities. As part of the body's stress response to the erratic pattern of breathing, both blood pressure and heart rate may rise to a level that is harmful in a failing heart, exacerbating the underlying heart failure. Indeed patients who demonstrate this CSA die sooner than those who have heart failure and stable breathing. There are no proven specific therapies for CSA that stabilise breathing, improve sleep quality, and prolong life. We have designed a system which delivers very small doses of CO2, when the blood level of CO2 is predicted to be low. During short daytime recordings, using this system, we have demonstrated that it is possible to stabilise the body's CO2 levels. We aim to test what happens when CO2 is given overnight whilst the patient is sleeping to see whether we can stabilise their breathing over longer durations and whether sleep quality could be improved so that patients are less tired during the day. In addition, we would like to measure whether the stress response is lessened if the breathing is successfully stabilised.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2010

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
27 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

January 5, 2010

Status Verified

January 1, 2010

Enrollment Period

8 months

First QC Date

January 4, 2010

Last Update Submit

January 4, 2010

Conditions

Sleep Apnea, Central

Keywords

Sleep apneaPeriodic breathingHeart Failure

Outcome Measures

Primary Outcomes (2)

  • Extent of respiratory instability

    over 8 hours

  • Arousals

    over 8 hours

Secondary Outcomes (6)

  • End-tidal CO2

    per breath

  • 24 hour urinary catecholamines

    per 24 hours

  • Mean heart rate

    per 1 s

  • Number of ectopic heart beats

    per 8 hours

  • Mean blood pressure

    every 9 hours

  • +1 more secondary outcomes

Interventions

Carbon dioxideOTHER

2% inhaled CO2 for up to 8 hours.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 18 to 79 years of age who have New York Heart Association (NYHA) functional class I through IV heart failure due to ischemic, hypertensive, or idiopathic dilated cardiomyopathy and whose condition had been stabilized by means of optimal medical therapy for at least one month;
  • An LVEF of less than 40% and central sleep apnea, defined as 15 or more episodes of apnea and hypopnea per hour of sleep, more than 50 percent of which are determined to be central rather than obstructive.

You may not qualify if:

  • Pregnancy,
  • Myocardial infarction,
  • Unstable angina or cardiac surgery within the previous three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Foundation G. Monasterio

Pisa, Pisa, 56124, Italy

Location

Imperial NHS Trust

London, London, W21NY, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Sleep Apnea, CentralSleep Apnea SyndromesHeart Failure

Interventions

Carbon Dioxide

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Carbon Compounds, InorganicInorganic ChemicalsGasesOxidesOxygen Compounds

Study Officials

  • Darrel P Francis, MD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 5, 2010

Study Start

February 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

January 5, 2010

Record last verified: 2010-01

Locations

GB(1)IT(1)