Clinical trial NCT02493907: Corrected Left Ventricular Electrical Delay Predicting Response to Cardiac Resynchronization Therapy
Official title: A Prospective Clinical Trial of Corrected Left Ventricular Electrical Delay Predicting Response to Cardiac Resynchronization Therapy in Chinese With Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Heart Failure
Cardiac Resynchronization Therapy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Southern Medical University, China
name: Fudan University
name: Beijing Chao Yang Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2015-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Left Ventricular End Systolic Volume (LVESV)
timeFrame: baseline and 6 months
Secondary outcomes:
measure: New York Heart Association (NYHA)
timeFrame: baseline and 6 months
measure: left ventricular ejection fraction (LVEF)
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jingfeng Wang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: