Corrected Left Ventricular Electrical Delay Predicting Response to Cardiac Resynchronization Therapy

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Heart Failure; Cardiac Resynchronization Therapy

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Juan Lei, M.D., Ph.D.; Phone Number: +86-13650894373; Email: leijuan_1@hotmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
      • Contact: Juan Lei, M.D., Ph.D.; Phone Number: +86-13650894373; Email: leijuan_1@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Heart failure patients received CRT in Sun Yat-sen Memorial Hospital, Sun Yat-sen University. Informed consent must be obtained for all of the included patients.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
heart failure; heart failure patients with CRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left Ventricular End Systolic Volume (LVESV)	change in LVESV	baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New York Heart Association (NYHA)	change in NYHA	baseline and 6 months
left ventricular ejection fraction (LVEF)	change in LVEF	baseline and 6 months

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Fudan University; First Affiliated Hospital, Sun Yat-Sen University; Beijing Chao Yang Hospital; Southern Medical University, China
• Investigators: Principal Investigator: Jingfeng Wang, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: [2014] ethics register [34]