Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
182 participants
OBSERVATIONAL
2010-10-31
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cardiac Resynchronisation Therapy In Patients With Heart Failure: Mechanistic Insights From Cardiac MRI And Electroanatomical Mapping
NCT04322877
Predicting Response to Cardiac Resynchronization Therapy in Heart Failure
NCT00359372
Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study
NCT00632372
Cardiac Resynchronization Therapy, Dyspnea and Exercise Tolerance in Patients With Congestive Heart Failure (CHF)
NCT00700700
Developing a New, Dynamic, Therapeutic Pacemaker Algorithm for Stabilising Periodic Breathing in Chronic Heart Failure.
NCT01044407
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
OBJECTIVE To conduct a physiological observational study to measure hypercapnic ventilatory responses in a group of CHF patients before and 3 months after implantation of clinically indicated CRT devices. Additionally to conduct nocturnal polysomnography to establish if any change in chemosensitivity is related to the presence of SDB at baseline and, where present, any change in SDB after implantation.
HYPOTHESIS Primary hypothesis: CRT implantation will be associated with a reduction in the hypercapnic ventilatory response from baseline to 3 months post implantation.
Additional hypothesis: This reduction in hypercapnic ventilatory response after CRT implantation will be greatest in those CHF patients with SDB at baseline.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients undergoing clinically indicated CRT implantation
Patients may be included in the study if they fulfil the following;
1. Age ≥18 years old
2. Fulfil the current guidance for the implantation of a CRT device; optimal medical treatment for heart failure, broad QRS complex on electrocardiogram with or without evidence of cardiac dyssynchrony as appropriate, LVEF \<35%, functional impairment as defined by an NYHA class of III-IV
3. Clinically stable with no unplanned admission to hospital for preceding 4 weeks
4. No changes in medications for heart failure in preceding 4 weeks
5. Able to read and understand patient information sheet and give informed consent
Patients must be excluded from the study if they fulfil they the following;
1. On positive pressure treatment for known sleep disordered breathing at the time of inclusion
2. Other known condition (untreated) likely to significantly disturb sleep eg. Restless legs syndrome, pain from any cause etc.
3. Pregnancy
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Fulfil the current guidance for the implantation of a CRT device; optimal medical treatment for heart failure, broad QRS complex on electrocardiogram with or without evidence of cardiac dyssynchrony as appropriate, LVEF \<35%, functional impairment as defined by an NYHA class of III-IV
3. Clinically stable with no unplanned admission to hospital for preceding 4 weeks
4. No changes in medications for heart failure in preceding 4 weeks
5. Able to read and understand patient information sheet and give informed consent
Exclusion Criteria
2. Other known condition (untreated) likely to significantly disturb sleep eg. Restless legs syndrome, pain from any cause etc.
3. Pregnancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Imperial College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rebecca Lucas
Mrs
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Brompton Hospital
London, London, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
National Institute of Clinical Excellence; technology appraisal about CRT devices
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10/H0706/5
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.