Corrected Left Ventricular Electrical Delay Predicting Response to Cardiac Resynchronization Therapy

Chronic Heart Failure Clinical Trial

Official title:

A Prospective Clinical Trial of Corrected Left Ventricular Electrical Delay Predicting Response to Cardiac Resynchronization Therapy in Chinese With Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02493907
• Other study ID #: [2014] ethics register [34]
• Status: Recruiting
• Phase: N/A
• First received: July 2, 2015
• Last updated: April 27, 2017
• Start date: December 2014
• Est. completion date: December 2018

Study information

• Verified date: April 2017
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Juan Lei, M.D., Ph.D.
• Phone: +86-13650894373
• Email: leijuan_1[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cardiac resynchronization therapy (CRT) is a well-established treatment for patients with severe systolic heart failure (HF) and ventricular desynchronization. Despite the consistently observed structural and functional improvements as well as reductions in HF events and mortality in large multicenter randomized trials, 30% patients remain classified as nonresponders. Present evidences showed that QRS duration was the most effective parameter to predict responsivity of CRT in patients with severe HF. But some studies showed that QRS duration could be influenced by obesity and gender. Accordingly, the simple QRS interval width of body surface electrocardiograph should not be the most satisfactory parameter for screening patients suitable for CRT. Recent study showed that left ventricular electrical delay, as measured by the time from the onset of QRS to the LV electrogram peak (QLV), predicted CRT response. At long QLV intervals, atrioventricular optimization (AVO) can increase the likelihood of structural response to CRT. However, it is unclear whether it is suitable for Chinese patients. The investigators would like to validate this relation in a Chinese population and explore if a corrected QLV might do better to predict the responsivity of CRT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• •More than 18 Years

• Informed consent signed

• NYHA class = II, an ejection fraction of = 0.35, QRS duration of = 150 milliseconds with Non-LBBB) or = 120 milliseconds with LBBB, who treated with CRT

• The Estimated survival time was more than one year

• sinus rhythm, pacemaker independent

Exclusion Criteria:

• •NYHA class I symptoms

• Severe liver or kidney dysfunction

• Valvular heart disease

• Pregnancy or lactation women

• percutaneous coronary intervention (PCI) or cardiac artery bypass graft (CABG) within 3 month

• Have malignant tumors and the Estimated survival time was less than one year

• an enzyme-positive myocardial infarction within 3 months before enrollment, or atrial fibrillation

• any reasons cannot complete follow-up; Or researchers think that don't suit to be included in the research of other conditions

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Chronic Heart Failure
• Heart Failure

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (6)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Beijing Chao Yang Hospital, First Affiliated Hospital, Sun Yat-Sen University, Fudan University, Southern Medical University, China, The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular End Systolic Volume (LVESV)	change in LVESV	baseline and 6 months
Secondary	New York Heart Association (NYHA)	change in NYHA	baseline and 6 months
Secondary	left ventricular ejection fraction (LVEF)	change in LVEF	baseline and 6 months