The Effect of CRT on the Hypercapnic Ventilatory Response

NCT02203383 | Suspended DMC

• 1 other identifier: 14/LO/0078
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Central Sleep Apnoea (CSA) affects up to half of patients with severe heart failure and is associated with a poor prognosis. CSA is manifest as episodes of deep breathing interspersed with very shallow or absent breathing and is largely due to an exaggerated response to rising carbon dioxide in the blood, which normally drives how hard we breathe. Cardiac Resynchronization therapy (CRT), in which a pacemaker is implanted to improve co-ordinated contraction of the heart, has been shown to reduce the severity of CSA in some patient groups. We aim to determine whether this improvement is due to normalization of the body's response to carbon dioxide in the blood. Our hypothesis is that CRT improves CSA by normalizing the brain's response to carbon dioxide.

Conditions

Sleep Disordered Breathing; Heart Failure

Keywords

Cardiac Resynchronization Therapy; Central Sleep Apnoea; Sleep Disordered Breathing; Heart Failure; Hypercapnic Ventilatory Response

Outcome Measures

Primary Outcomes (1)

• The change in gradient of minute ventilation vs end tidal CO2 before and after CRT (the hypercapnic ventilatory response).

  6 weeks and 6 months

Secondary Outcomes (4)

• 6 minute walk distance

  6 weeks and 6 months

• Change in resting PaCO2

  6 weeks and 6 months

• Change in left ventricular ejection fraction

  6 weeks and 6 months

• Change in plasma B-Type Natriuretic Peptide level

  6 weeks and 6 months

Study Arms (2)

Pts with CSA for CRT implantation

Patients with heart failure (EF\<40%) and moderate to severe CSA (\>15 events per hour, \>50% Central)

Device: CRT Implantation

No Sleep Apnoea for CRT implantation

Heart failure (EF \< 40%) but no significant sleep apnoea (\<5 events per hour).

Device: CRT Implantation

Interventions

CRT Implantation DEVICE

Implantation of a biventricular pacemaker or defibrillator.

Also known as: INVIVE, INCEPTA, AUTOGEN

No Sleep Apnoea for CRT implantation; Pts with CSA for CRT implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure with reduced ejection fraction (\<40% on echocardiography) due to undergo implantation of a biventricular pacemaker, with either no significant sleep disordered breathing or moderate to severe CSA.

You may qualify if:

• Heart failure with reduced ejection fraction (\<40%)
• Either no significant sleep disordered breathing or moderate to severe CSA
• Able to consent to the study
• Ambulatory
• Aged 18-100 years

You may not qualify if:

• Patients on Non-Invasive Ventilation
• Predominant OSA
• Unable to consent or attend for the study

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Royal Brompton and Harefield NHS Foundation Trust

London, SW6 6NP, United Kingdom

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Heart Failure; Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Ali Vazir, PhD

  Imperial College. Royal Brompton Hospital

  PRINCIPAL INVESTIGATOR

• Martin Cowie, MD

  Imperial College London

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: July 29, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 9, 2016

Record last verified: 2016-11

Locations

GB (1)