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

Not Applicable

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

Registration Number: CTRI/2014/05/004583

Lead Sponsor: Medanta The Medicity

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 320

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Secondary endpoints (from baseline to up to three years) will be: <br/ ><br>- 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%). <br/ ><br>- Comparison of the rate of completion of the planned chemotherapy among groups. <br/ ><br>- Comparison of the rate of heart failure among groups.Timepoint: 3 years