None listed
Conditions
Brief summary
The purpose of this research is to explore the effect of stopping heart medication in cancer patients whose hearts have recovered from chemotherapy-related cardiac dysfunction (CTRCD). Who is it for? You may be eligible for this study if you are aged 18 or older, you have been previously diagnosed with asymptomatic CTRCD and you are currently taking CTRCD medications including Angiotensin Converting Enzyme inhibitors (ACEi) and/or Beta Blockers (BB). Study details All participants who choose to enrol in this study will be randomly divided into one of two groups by chance (similar to flipping a coin). One group will continue their heart medications as prescribed. The second group will cease their heart medications (Angiotensin Converting Enzyme inhibitors (ACEi) and/or Beta Blockers (BB)) under medical supervision, this will occur over a staged period. All participants regardless of their group allocation will undergo monthly clincial review. An echocardiogram (heart ultrasound, approximately one hour), Electrocardiogram (ECG), blood tests and cardiac magnetic resonance imaging (CMR) will be taken at the start and end of study involvement. It is hoped this research will determine whether completely stopping cardiac medications including ACE inhibitors and beta blockers is safe and whether this has any negative impacts on patients with previous chemotherapy related cardiac dysfunction. If this treatment cessation is safe it may be used to improve health outcomes for future cancer patients who are affected by chemotherapy related cardiac dysfunction.
Interventions
Supervised withdrawal of cardioprotective therapies will occur in a staged fashion soon post randomisation by the research team, which includes a cardiologist. The prinicipal investigator will be responsible for the overall medication withdrawal.
Firstly, beta-blockers will be titrated down to cessation with weekly dose reductions. Subsequently, angiotensin converting enzyme inhibitors/angiotensin receptor blockers will be titrated down to cessation with weekly dose reductions. We aim for parti
Supervised withdrawal of cardioprotective therapies will occur in a staged fashion soon post randomisation by the research team, which includes a cardiologist. The prinicipal investigator will be responsible for the overall medication withdrawal. Firstly, beta-blockers will be titrated down to cessation with weekly dose reductions. Subsequently, angiotensin converting enzyme inhibitors/angiotensin receptor blockers will be titrated down to cessation with weekly dose reductions. We aim for participants to cease all revelant medications within 6 weeks of randomisation. Should participants experience symptoms suggestive of heart failure, they will be reviewed by the research team and discussed with an independent cardiologist for recommencement of medical therapy. Adherence to withdrawal will be monitored at protocol stipulated clinical reviews.
Sponsors
Nepean Blue Mountains Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
17 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Previously diagnosed asymptomatic chemotherapy related cardiac dysfunction (CTRCD) (defined as: LVEF drop >10% to a value below <55% from baseline or GLS drop greater than or equal to 12% from baseline) LVEF of >50%. NYHA Class I Current CTRCD therapy – Angiotensin Converting Enzyme inhibitor (ACEi) AND/OR Beta Blocker (BB) Completed HER2 receptor therapy (traztuzumab/pertuzumab)
Exclusion criteria
• History of ischaemic heart disease • Hypertension requiring medical therapy • Moderate or greater severity valvular disease • Chronic kidney disease • Atrial, supraventricular, or ventricular arrhythmia requiring BB therapy • Pregnancy • < 16 years old
Outcome results
None listed