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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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The investigators are examining the relationship between heart rate and heart contraction in patients with heart failure and pacemakers, aiming to improve quality of life.
Heart rate lowering is a cornerstone of the management of chronic heart failure (CHF) and the degree of lowering is closely related to improvements in longevity, hospitalisation rate and heart function. The investigators have shown that increasing heart rates using pacemakers does not increase exercise capacity in CHF patients. This might be because the optimal heart rate range for contraction is narrower for patients with CHF. At higher heart rates, heart contraction might be less strong. The investigators now want to examine the relationship between heart rate and heart contraction in patients with heart failure and pacemakers. Tailored pacemaker heart rate setting's, individually optimised for heart contractility as assessed by cardiac ultrasound, will be investigated to examine the effects on exercise tolerance .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard pacemaker settings | No Intervention | Standard pacemaker settings will be programmed and the patient will complete a symptom limited exercise tolerance test with metabolic gas exchange | |
| Tailored pacemaker settings | Experimental | The pacemaker settings will be altered to match optimal heart rate range with respect to cardiac contractility, as determined by echocardiography. This will be programmed and the patient will complete a symptom limited exercise tolerance test with metabolic gas exchange. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored pacemaker settings | Device | Tailored pacemaker settings, optimised for cardiac contractility: Pacemaker settings, optimised for cardiac contractility as determined by echocardiography, will be programmed |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Exercise Time | Exercise duration in seconds | Assessed following the second treadmill test, 1 week later |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Oxygen Consumption (pVO2) | Peak Oxygen Consumption (pVO2) measured by metabolic gas exchange | Assessed following the second treadmill test, 1 week later |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Gierula, BSc | Contact | 00441333923131 | J.Gierula@leeds.ac.uk | |
| Klaus K Witte, MD | Contact | k.k.witte@leeds.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| John Gierula, BSc | University of Leeds | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds Institute of Cardiovascular and Metabolic Medicine | Recruiting | Leeds | West Yorkshire | LS2 9JT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21185094 | Background | Al-Najjar Y, Witte KK, Clark AL. Chronotropic incompetence and survival in chronic heart failure. Int J Cardiol. 2012 May 17;157(1):48-52. doi: 10.1016/j.ijcard.2010.11.018. Epub 2010 Dec 23. | |
| 20525704 | Background | Shelton RJ, Ingle L, Rigby AS, Witte KK, Cleland JG, Clark AL. Cardiac output does not limit submaximal exercise capacity in patients with chronic heart failure. Eur J Heart Fail. 2010 Sep;12(9):983-9. doi: 10.1093/eurjhf/hfq086. Epub 2010 Jun 4. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 1, 2018 | |
| Reset | Dec 6, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 1, 2018 | Dec 6, 2018 |
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| 18571253 | Background | Witte KK, Clark AL. Chronotropic incompetence does not contribute to submaximal exercise limitation in patients with chronic heart failure. Int J Cardiol. 2009 May 29;134(3):342-4. doi: 10.1016/j.ijcard.2008.02.014. Epub 2008 Jun 20. |
| 16996845 | Background | Thackray SD, Ghosh JM, Wright GA, Witte KK, Nikitin NP, Kaye GC, Clark AL, Tweddel A, Cleland JG. The effect of altering heart rate on ventricular function in patients with heart failure treated with beta-blockers. Am Heart J. 2006 Oct;152(4):713.e9-13. doi: 10.1016/j.ahj.2006.07.007. |
| 16923470 | Background | Witte KK, Clark AL. Resting left ventricular function, however measured, is poorly related to exercise capacity in chronic heart failure. Am J Cardiol. 2006 Sep 1;98(5):709-10. doi: 10.1016/j.amjcard.2006.05.002. Epub 2006 Jul 5. No abstract available. |
| 16875998 | Background | Witte KK, Clark AL. Chronotropic incompetence in heart failure. J Am Coll Cardiol. 2006 Aug 1;48(3):595; author reply 595-6. doi: 10.1016/j.jacc.2006.05.014. Epub 2006 Jul 12. No abstract available. |
| 16159968 | Background | Witte KK, Cleland JG, Clark AL. Chronic heart failure, chronotropic incompetence, and the effects of beta blockade. Heart. 2006 Apr;92(4):481-6. doi: 10.1136/hrt.2004.058073. Epub 2005 Sep 13. |
| 12804929 | Background | Thackray SD, Witte KK, Nikitin NP, Clark AL, Kaye GC, Cleland JG. The prevalence of heart failure and asymptomatic left ventricular systolic dysfunction in a typical regional pacemaker population. Eur Heart J. 2003 Jun;24(12):1143-52. doi: 10.1016/s0195-668x(03)00199-4. |
| 29226818 | Derived | Gierula J, Paton MF, Lowry JE, Jamil HA, Byrom R, Drozd M, Garnham JO, Cubbon RM, Cairns DA, Kearney MT, Witte KK. Rate-Response Programming Tailored to the Force-Frequency Relationship Improves Exercise Tolerance in Chronic Heart Failure. JACC Heart Fail. 2018 Feb;6(2):105-113. doi: 10.1016/j.jchf.2017.09.018. Epub 2017 Dec 6. |