Heart FailurePEACHNCT02814942
Prospective Evaluation of Asians With CRT for Heart Failure
An observational study of Heart Failure and Cardiac Resynchronisation Therapy, run by National University Heart Centre, Singapore at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiac Resynchronisation Therapy
- What is being tested?
- Cardiac Resynchronization Therapy
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2011to Dec 2030
- How long will I take part?
- 8 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Singaporean patients with broad QRS complexes, EF <40%, heart failure, requiring CRT
Who may be able to join
- Broad QRS (>120 ms)
- EF < 40%
- Symptomatic heart failure
- Not on optimal medical therapy
Who cannot join
- Pregnant
- < 18 years of age
- Infection
- Unable to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pipin Kojodjojo, MD PHD contact
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
Pipin Kojodjojo, MD PHD, 67795555
Swee Chong Seow, MD
About this study
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%.
Read the detailed description
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%.
- Conditions
- Heart Failure, Cardiac Resynchronisation Therapy
- Being tested
- Cardiac Resynchronization Therapy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Resynchronization TherapyDevice
Cardiac resynchronization therapy with or without ICD
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure receiving CRT | Heart failure patients with QRS > 120ms receiving CRT Receives: Device: Cardiac Resynchronization Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic response to CRT
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
Measured: 6 months
Secondary outcomes (4)
Neuroendocrine response to CRT
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
Measured: 6 months
Clinical response to CRT
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%
Measured: 6 months
Hospitalization For Cardiovascular events
Hospitalisation for acute coronary syndrome, heart failure, arrhythmias, ICD shocks or any unplanned admissions for any cardiac interventions or surgery
Measured: 8 years
Mortality
Mortality
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- National University Heart Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pipin Kojodjojo, National University Heart Centre, Singapore
- Investigators
- Swee Chong Seow, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814942
- Sponsor's protocol ID
- 2016/00608
- Other IDs
- 2016
- Acronym
- PEACH
- Status last verified
- Mar 2021
- First submitted
- 22 Jun 2016
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Asians With CRT for Heart Failure
- ClinicalTrials.gov ID
- NCT02814942
- Acronym / sponsor ID
- PEACH / 2016/00608
- Conditions
- Heart Failure, Cardiac Resynchronisation Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- National University Heart Centre, SingaporeUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Detailed description
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%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure receiving CRT | – | Device: Cardiac Resynchronization TherapyHeart failure patients with QRS > 120ms receiving CRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Singaporean patients with broad QRS complexes, EF <40%, heart failure, requiring CRT
Key inclusion criteria (4 listed)
- Broad QRS (>120 ms)
- EF < 40%
- Symptomatic heart failure
- Not on optimal medical therapy
Key exclusion criteria (4 listed)
- Pregnant
- < 18 years of age
- Infection
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Resynchronization TherapyCardiac resynchronization therapy with or without ICD | Device | Heart Failure receiving CRT |
Primary outcome
Echocardiographic response to CRT
Time frame: 6 months
A subject is considered an echocardiographic responder to CRT if there is: 1. reduction in the iLVESV (left ventricular end-systolic volume index to body surface area) of >/= 15% OR 2. an increase in the LVEF of >/= 10% during follow-up echocardiography at 6 months
4 secondary outcomes
Neuroendocrine response to CRT
Time frame: 6 months
Clinical response to CRT
Time frame: 6 months
Hospitalization For Cardiovascular events
Time frame: 8 years
Mortality
Time frame: 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pipin Kojodjojo, MD PHD contact
Swee Chong Seow, MD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiac Resynchronisation Therapy, run by National University Heart Centre, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pipin Kojodjojo, MD PHD (67795555), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic response to CRT (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.