Heart Failure
Conditions
Brief summary
This is a prospective study in which a process of identifying and reducing heart failure (HF) risk will be applied to cancer survivors \>55 years old with chemotherapy \>5 years ago. The overall goal of this study to identify the feasibility and value of risk-guided cardiac rehabilitation (exercise, risk factor modification, and behavioural support) as a component of survivorship care.
Detailed description
Participants enrolled in this study will be randomized to cardio-oncology disease management plan ( CO-DMP) that involves the use of surveillance imaging to detect subclinical left ventricular dysfunction (LVD), clinical review to ensure optimal risk factor control and cardio-protection and exercise/sedentariness intervention. The intervention will be delivered over a period of 6 months. Usual care patients will then cross over the CO-DMP for 6 months. The outcome from this study will show that subclinical LVD is more common among long term cancer survivors, and a CO-DMP is feasible in reducing HF risk factors in this sub group of survivors.
Interventions
OTHERHeart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)
A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.
OTHERUsual care
provided by participants' usual healthcare professional(s)
Sponsors
Baker Heart and Diabetes Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor will receive study data based on pooled de identified dataset.
Intervention model description
Randomization to CO-DMP or usual care
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. History of cancer \> 10 years ago 2. Have received potentially toxic chemotherapy Anthracycline (any dose) Trastuzumab (Herceptin) in breast-cancer with the HER2 mutation OR Tyrosine kinase inhibitors (e.g. sunitinib) OR Left chest radiotherapy
Exclusion criteria
1. Ejection fraction at baseline echo \<50% 2. Valvular stenosis or regurgitation of \>moderate severity 3. History of previous heart failure (baseline New York Heart Association (NYHA) classification \>2) 4. Systolic BP \<110 mmHg 5. Pulse \<60/minute if not on beta blocker 6. Inability to acquire interpretable images (identified from baseline echo) 7. Contraindications to beta blockers or angiotensin-converting enzyme inhibitors 8. 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 9. Already taking both angiotensin converting enzyme inhibitors/angiotensin receptor blockers and beta blockers, or intolerance (or allergy) to both. 10. Unable to provide written informed consent to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in exercise capacity | Over a period of 6 months | Cardio pulmonary fitness (peak oxygen uptake (VO2 peak)) from baseline to follow up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence | Over a period of 6 months | proportion of ACEi and beta blocker tablets taken |
| Neuromuscular strength | Over a period of 6 months | Maximal isometric grip strength (kg) assessed using a digital grip strength dynamometer |
| Endurance | Over a period of 6 months | Increase in total exercise duration. |
| Left ventricular function | Over a period of 6 months | Change in global longitudinal strain (GLS) using echocardiographic speckle-tracking |
Countries
Australia
Contacts
Primary ContactJoel Smith
Backup ContactThomas H Marwick, MD,PhD,MPH
Outcome results
None listed