Observational study on new echocardiographic modality for early detection and prevention of heart muscle damage during cancer chemotherapy

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/05/004583
• Date of registration: 06-05-2014
• Prospective Registration: Yes
• Primary sponsor: Medanta The Medicity
• Public title: Observational study on new echocardiographic modality for early detection and prevention of heart muscle damage during cancer chemotherapy
• Scientific title: Strain sUrveillance during Chemotherapy for imroving Cardiovascular OUtcomes - SUCCOUR Study
• Date of first enrolment: 12-05-2014
• Target sample size: 320
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8418
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

Australia, Belgium, Bulgaria, Canada, Germany, India, Italy, Japan, Norway, Romania, Spain

Contacts

• Name: Dr Manish Bansal
• Affiliation: Medanta The Medicity

• Name: Dr Manish Bansal
• Affiliation: Medanta The Medicity

Key inclusion & exclusion criteria

Inclusion criteria: i. Patients actively undergoing chemotherapy at increased risk of cardiotoxicity;

use of anthracycline WITH (not necessarily concurrently)

trastuzumab (Herceptin) in breast-cancer with the HER2 mutation OR

tyrosine kinase inhibitors (eg sunitinib) OR

cumulative anthracycline doses >450g/m2 OR

increased risk of HF (age >65y, type 2 diabetes mellitus, hypertension, previous cardiac injury eg. myocardial infarction)

ii. Live within a geographically accessible area for follow-up

iii. Are able and willing to provide written informed consent to participate in the study (this includes the ability to communicate fluently with the investigator and that the patient is mentally competent)
Exclusion criteria: ï?? Unable to provide written informed consent to participate in this study

ï?? Participating in another clinical research trial where randomized treatment would be unacceptable

ï?? Valvular stenosis or regurgitation of >moderate severity

ï?? History of previous heart failure (baseline NYHA >2)

ï?? Systolic BP <110mmHg

ï?? Pulse <60/minute

ï?? Inability to acquire interpretable images (identified from baseline echo)

ï?? Contraindications/Intolerance to beta blockers or ACE inhibitors

ï?? Oncologic (or other) life expectancy <12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Patients undergoing chemotherapy and having high risk of cardiotoxixity

Intervention(s)

Intervention1: conventional echocardiography: In one group, heart failure will be diagnosed using conventional echocardiography which uses standard two-dimensional, three-dimensional, and Doppler ultrasound to create images of the heart.
Control Intervention1: specialized echocardiography i.e. strain imaging: the patients undergoing strain imaging are expected to be initiated on heart failure treatment at an earlier stage of illness as compared to the patients in the other group but the nature of the treatment (drugs/ doses) will be identical.

Primary Outcome(s)

Consistent with the study hypothesis, the primary study end-point is change in 3D ejection fraction from baseline to up to three years, as determined by a blinded core laboratory and analyzed on an intention-to-treat basis according to random study group allocation.Timepoint: 3 years

Secondary Outcome(s)

Secondary endpoints (from baseline to up to three years) will be:

- Development of cardiotoxicity â?? ie a categorical analysis of reduced LVEF concordant with the recent guidelines (reduction of LVEF of more than 5% to less than 55% with symptoms of heart failure, or an asymptomatic reduction of LVEF of more than 10% to less than 55%).

- Comparison of the rate of completion of the planned chemotherapy among groups.

- Comparison of the rate of heart failure among groups.Timepoint: 3 years

Secondary ID(s)

NIL

Source(s) of Monetary Support

Medanta, The Medicity

Secondary Sponsor(s)

Menzies Research Institute

Ethics review

Status: Approved
Approval date: 13/01/2014
Contact:

Medanta Institutional Ethics Committee