Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304896
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-05
Brief Title:
Colchicine Versus Beta-blockers Angiotensin-converting Enzyme Inhibitors and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy
Sponsor:
Arab Contractors Medical Centre
Organization:
Arab Contractors Medical Centre
Study Overview
Official Title:
Colchicine Versus Beta-blockers Angiotensin-converting Enzyme Inhibitors and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BASiC-CIC
Brief Summary:
BASiC-CIC Trial is a multicenter double-blinded randomized placebo-controlled clinical trial to investigate whether repurposing colchicine or a combination of beta-blockers angiotensin-converting enzyme ACE inhibitors and statins will be effective as a prophylactic treatment for the prevention of chemotherapy-induced cardiomyopathy reduction of major adverse cardiovascular events and all-cause mortality
Detailed Description:
The 2021 European Society of Cardiology ESC guidelines recommend that the treatment with angiotensin-converting enzyme inhibitors ACEi and a beta-blocker preferably carvedilol should be considered in cancer patients developing left ventricle systolic dysfunction defined as a 10 or more decrease in left ventricular ejection fraction LVEF from baseline value or a value lower than 50 during anthracycline chemotherapy This statement has a class of recommendation of II with a level of evidence B which means that the weight of evidenceopinion is in favor of the usefulness of these treatments The statement recommends starting the dual treatment after echocardiographic evidence of cardiac affection Therefore whether pre-treatment with these dual cardio-protective agents will protect the patients heart from the toxic effects of the chemotherapeutic intervention is unclear
Additionally The 2022 ACCAHAHFSA American guidelines recommend that in asymptomatic patients with cancer therapy-related cardiomyopathy ejection fraction50 angiotensin-receptor blocker ARBsand beta-blockers are reasonable to prevent progression to heart failure and improve cardiac function The statement also recommends starting the dual treatment after echocardiographic evidence of cardiac affection However these guidelines state that in patients at risk of cancer therapy-related cardiomyopathy initiation of beta blockers and ACEiARB for the primary prevention of drug-induced cardiomyopathy is of uncertain benefit and further clinical research is an unmet need Accordingly the effectiveness of preemptive use of ACEi-ARB andor selected beta-blockers such as carvedilol and nebivolol in reducing the risk of cancer therapy-related cardiomyopathy has been investigated in a number of small clinical trials with conflicting findings Additionally statins have pleiotropic therapeutic effects that range from endothelial stabilization to suppression of inflammation However its role in decreasing disease morbidity repeated hospitalization in established chronic heart failure is also uncertain
On the other hand colchicine is an immunomodulator that accumulates in the white blood cells and affects them in a variety of ways including decreasing motility mobilization and adhesion Generally colchicine appears to inhibit multiple proinflammatory mechanisms while enabling increased levels of anti-inflammatory mediators In a randomized trial involving patients with chronic coronary disease the risk of cardiovascular events was significantly lower among those who received 05 mg of colchicine once daily than among those who received a placebo Accordingly colchicine can reduce the risk of cardiovascular events in patients with chronic coronary artery disease but its efficacy in improving the functional status in patients with established chronic heart failure is also uncertain While the use of this immunomodulatory agent in established heart failure is uncertain its effectiveness in the prophylactic reduction of chemotherapy-induced cardiomyopathy in patients with normal pre-treatment ejection fraction has not been investigated
Accordingly 150 enrolled cancer patients who are candidates for guideline-directed anthracycline-based chemotherapy with or without the anti-HER2 trastuzumab at the time of presentation will undergo the following
General and Local cardiac examination
CBC
Chemistry Panel including KFTs LFTs
Serum electrolytes levels
Baseline resting surface 12 leads ECG followed by serial recording monthly for a total of 6 months
Baseline Echocardiography followed by serial imaging every 2 months for a total of 6 months
Baseline serum BNP testNT-proBNP followed by serial testing every 2 months for a total of 6 months
Additionally The 2022 ACCAHAHFSA American guidelines recommend that in asymptomatic patients with cancer therapy-related cardiomyopathy ejection fraction50 angiotensin-receptor blocker ARBsand beta-blockers are reasonable to prevent progression to heart failure and improve cardiac function The statement also recommends starting the dual treatment after echocardiographic evidence of cardiac affection However these guidelines state that in patients at risk of cancer therapy-related cardiomyopathy initiation of beta blockers and ACEiARB for the primary prevention of drug-induced cardiomyopathy is of uncertain benefit and further clinical research is an unmet need Accordingly the effectiveness of preemptive use of ACEi-ARB andor selected beta-blockers such as carvedilol and nebivolol in reducing the risk of cancer therapy-related cardiomyopathy has been investigated in a number of small clinical trials with conflicting findings Additionally statins have pleiotropic therapeutic effects that range from endothelial stabilization to suppression of inflammation However its role in decreasing disease morbidity repeated hospitalization in established chronic heart failure is also uncertain
On the other hand colchicine is an immunomodulator that accumulates in the white blood cells and affects them in a variety of ways including decreasing motility mobilization and adhesion Generally colchicine appears to inhibit multiple proinflammatory mechanisms while enabling increased levels of anti-inflammatory mediators In a randomized trial involving patients with chronic coronary disease the risk of cardiovascular events was significantly lower among those who received 05 mg of colchicine once daily than among those who received a placebo Accordingly colchicine can reduce the risk of cardiovascular events in patients with chronic coronary artery disease but its efficacy in improving the functional status in patients with established chronic heart failure is also uncertain While the use of this immunomodulatory agent in established heart failure is uncertain its effectiveness in the prophylactic reduction of chemotherapy-induced cardiomyopathy in patients with normal pre-treatment ejection fraction has not been investigated
Accordingly 150 enrolled cancer patients who are candidates for guideline-directed anthracycline-based chemotherapy with or without the anti-HER2 trastuzumab at the time of presentation will undergo the following
General and Local cardiac examination
CBC
Chemistry Panel including KFTs LFTs
Serum electrolytes levels
Baseline resting surface 12 leads ECG followed by serial recording monthly for a total of 6 months
Baseline Echocardiography followed by serial imaging every 2 months for a total of 6 months
Baseline serum BNP testNT-proBNP followed by serial testing every 2 months for a total of 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None