Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02814942

Prospective Evaluation of Asians With CRT for Heart Failure

Aim:To determine the baseline characteristics of heart failure patients in Singapore undergoing cardiac resynchronization therapy (CRT); the long term outcome and predictors of response to CRT.

Methodology:Among patients undergoing CRT for severe heart failure according to indications stipulated in international Cardiology guidelines, baseline demographic data is collected. Age, gender, NYHA functional class, co-morbidities, QRS width on ECG, presence of left bundle branch block pattern on ECG, presence of atrial fibrillation, left ventricular ejection fraction (LVEF) on echocardiogram, ventricular dimensions, 6 min walk test distance are collected. In addition, during the CRT implant procedure, blood is drawn from the vascular access and analysed for NT-pro BNP levels and other biomarkers of heart failure.

The echocardiographic and ECG parameters and blood biomarkers are reanalysed at 6 months and 12 months following CRT implant. Response to CRT is defined as a reduction in the iLVESV (left ventricular end-systolic volume index to body surface area) of >/= 15% and/or an increase in the LVEF of >/= 10%.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Heart Failure Cardiac Resynchronisation Therapy Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National University Hospital

Singapore

Location status: Recruiting

Location contact

Pipin Kojodjojo, MD PHD

CONTACT

67795555

Swee Chong Seow, MD

PRINCIPAL_INVESTIGATOR

About this study

Among patients undergoing CRT for severe heart failure according to indications stipulated in international Cardiology guidelines, baseline demographic data is collected. Age, gender, NYHA functional class, comorbidities, QRS width on ECG, presence of left bundle branch block pattern on ECG, presence of atrial fibrillation, left ventricular ejection fraction (LVEF) on echocardiogram, ventricular dimensions, 6 min walk test distance are collected. In addition, during the CRT implant procedure, blood is drawn from the vascular access and analysed for NT-pro BNP levels and other biomarkers of heart failure. The echocardiographic and ECG parameters and blood biomarkers are reanalysed at 6 months and 12 months following CRT implant. Response to CRT is defined as a reduction in the iLVESV (left ventricular end-systolic volume index to body surface area) of >/= 15% and/or an increase in the LVEF of >/= 10%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Broad QRS (>120 ms)
  • EF < 40%
  • Symptomatic heart failure
  • Not on optimal medical therapy

Exclusion criteria

  • Pregnant
  • < 18 years of age
  • Infection
  • Unable to consent

Treatment and study plan

cardiac resynchronization therapy

Device

Cardiac resynchronization therapy with or without ICD

Primary outcomes

  1. Echocardiographic response to CRT

    Time frame: 6 months

    A subject is considered an echocardiographic responder to CRT if there is:

    • reduction in the iLVESV (left ventricular end-systolic volume index to body surface area) of >/= 15% OR
    • an increase in the LVEF of >/= 10% during follow-up echocardiography at 6 months

Secondary outcomes

  1. Neuroendocrine response to CRT

    Time frame: 6 months

    A subject is considered to have a neuro-endocrine response to CRT if BNP levels at 6 months post CRT implant has fallen more than 30% from baseline

  2. Clinical response to CRT

    Time frame: 6 months

    A subject is considered a positive clinical responder to CRT if:

    • NYHA class has improved by at least 1 class OR
    • 6 minutes walking test has increased by at least 10%

  3. Hospitalization For Cardiovascular events

    Time frame: 8 years

    Hospitalisation for acute coronary syndrome, heart failure, arrhythmias, ICD shocks or any unplanned admissions for any cardiac interventions or surgery

  4. Mortality

    Time frame: 8 years

    Mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Pipin Kojodjojo, MD PHD

CONTACT

67795555

Sponsors and collaborators

Lead sponsor

National University Heart Centre, Singapore

Other

Registry information

Acronym: PEACH

Important dates

Study start
2011
Primary completion
2030
Study completion
2030
First posted
Jun 28, 2016
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.