Chemotherapy Induced Systolic DysfunctionPhase 1BASiC-CICNCT06304896
Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy
A Phase 1 study testing Carvedilol, Ramipril and Rosuvastatin in people with Chemotherapy Induced Systolic Dysfunction, run by Arab Contractors Medical Centre at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Induced Systolic Dysfunction
- What is being tested?
- Carvedilol, Ramipril and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent prior to performing study procedures.
- A cancer patient who is a candidate for a guideline-directed, anthracycline-based chemotherapy with or without the anti-HER2 trastuzumab.
- Baseline LVEF ≥ 50% without evident structural heart disease by pre-treatment echocardiographic examination.
Who cannot join
- Critically ill Cancer patients who are admitted to ICU.
- Ischemic cardiomyopathy with LVEF ≤ 50%.
- Dilated cardiomyopathy with LVEF ≤ 50%.
- Advanced valvular heart disease (severe valvular affection in the form of stenosis or regurgitation).
- Systolic BP < 90 mmHg or diastolic BP < 60 mmHg.
- Liver cell failure.
Show all 12Show fewer
- End-stage chronic kidney disease on regular dialysis.
- Pregnancy.
- Lactation.
- Chronic muscle diseases such as dermatomyositis, polymyositis, or muscular dystrophy.
- Acute trauma or burns within 2 weeks.
- History of allergy to the implemented drugs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Arab Contractors Medical Centre
Cairo
Eslam Abbas, MBChB, MSc, 01023054574 ext. +2, islam.omr@med.au.edu.eg
About this study
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.
Read the 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 evidence/opinion 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 patient's heart from the toxic effects of the chemotherapeutic intervention is unclear.
Additionally, The 2022 ACC/AHA/HFSA American guidelines recommend that in asymptomatic patients with cancer therapy-related cardiomyopathy (ejection fraction<50%), angiotensin-receptor blocker (ARBs)and 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 ACEi/ARB 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 and/or 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 0.5 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 test/NT-proBNP followed by serial testing every 2 months for a total of 6 months.
- Being tested
- Carvedilol, Ramipril, Rosuvastatin, Colchicine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Also called Carvid, Coreg
Carvedilol 6.25 mg oral tablets. Prescribed: Twice daily PO with 200 mL of water.
RamiprilDrug
Also called Tritace, Altace
Ramipril 2.5 mg oral capsules. Prescribed: Once daily PO with 200 mL of water.
RosuvastatinDrug
Also called Crestor
Rosuvastatin 20 mg oral tablets. Prescribed: Once daily PO with 200 mL of water.
ColchicineDrug
Also called Colcrys, Mitigare
Colchicine 0.6 mg oral tablets/capsules. Prescribed: Once daily PO with 200 mL of water.
PlaceboDrug
Placebo oral capsules. Prescribed: Once daily PO with 200 mL of water.
| Study group | Role | What they receive |
|---|---|---|
| The Cardioprotective Group (CPG) | Active comparator | 50 patients will receive a low-dose Beta-blockers in the form of Carvedilol 6.25 mg PO twice daily, a low-dose ACE inhibitors in the form of Ramipril 2.5 mg PO once daily, and a statin in the form of rosuvastatin 20 mg oral tablets. Receives: Drug: Carvedilol; Drug: Ramipril; Drug: Rosuvastatin |
| The Immunomodulatory Group (IMG) | Active comparator | 50 patients will receive Colchicine 0.6 PO once daily. Receives: Drug: Colchicine |
| The Placebo Control Group (PCG) | Placebo comparator | 50 patients will receive a placebo as a control group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemotherapy-induced cardiomyopathy
An identification of a drop in the LVEF using echocardiography more than or equal to 10% from the baseline at the time of presentation and/or a decline of the LVEF less than 50%.
Measured: 6 months
Chemotherapy-induced cardiomyopathy
An identification of at least one value of serum NT-proBNP over 125 pg/mL in patients less than 75 years of age, or 450pg/mL in patients more than 75 years of age.
Measured: 6 months
Secondary outcomes (2)
Major Adverse Cardiovascular Events
The non-fatal major cardiovascular adverse events include:
- Non-fatal myocardial infarction.
- Non-fatal stroke.
- Hospitalization due to unstable angina.
- Hospitalization due to serious arrhythmias.
- Hospitalization due to heart failure.
Measured: 6 months
All-Cause Mortality
Mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy Induced Systolic DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arab Contractors Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Abbas, MBChB, MSc, Arab Contractors Medical Centre
- Investigators
- Eslam Abbas, MBChB, MSc, Principal investigator, Arab Contractors Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304896
- Sponsor's protocol ID
- #18240343
- Acronym
- BASiC-CIC
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sun X, Duan J, Gong C, Feng Y, Hu J, Gu R, Xu B. Colchicine Ameliorates Dilated Cardiomyopathy Via SIRT2-Mediated Suppression of NLRP3 Inflammasome Activation. J Am Heart Assoc. 2022 Jul 5;11(13):e025266. doi: 10.1161/JAHA.122.025266. Epub 2022 Jun 29.
PubMed 35766262Zhang FS, He QZ, Qin CH, Little PJ, Weng JP, Xu SW. Therapeutic potential of colchicine in cardiovascular medicine: a pharmacological review. Acta Pharmacol Sin. 2022 Sep;43(9):2173-2190. doi: 10.1038/s41401-021-00835-w. Epub 2022 Jan 19.
PubMed 35046517Kuo MC, Chang SJ, Hsieh MC. Colchicine Significantly Reduces Incident Cancer in Gout Male Patients: A 12-Year Cohort Study. Medicine (Baltimore). 2015 Dec;94(50):e1570. doi: 10.1097/MD.0000000000001570.
PubMed 26683907Zhang T, Chen W, Jiang X, Liu L, Wei K, Du H, Wang H, Li J. Anticancer effects and underlying mechanism of Colchicine on human gastric cancer cell lines in vitro and in vivo. Biosci Rep. 2019 Jan 15;39(1):BSR20181802. doi: 10.1042/BSR20181802. Print 2019 Jan 31.
PubMed 30429232Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.
PubMed 35083827Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
PubMed 35363499Bosch X, Rovira M, Sitges M, Domenech A, Ortiz-Perez JT, de Caralt TM, Morales-Ruiz M, Perea RJ, Monzo M, Esteve J. Enalapril and carvedilol for preventing chemotherapy-induced left ventricular systolic dysfunction in patients with malignant hemopathies: the OVERCOME trial (preventiOn of left Ventricular dysfunction with Enalapril and caRvedilol in patients submitted to intensive ChemOtherapy for the treatment of Malignant hEmopathies). J Am Coll Cardiol. 2013 Jun 11;61(23):2355-62. doi: 10.1016/j.jacc.2013.02.072. Epub 2013 Apr 10.
PubMed 23583763Golwala H. Enalapril/carvedilol for prevention of chemotherapy-induced heart failure: an end to the problem. J Am Coll Cardiol. 2013 Dec 24;62(25):2450-2451. doi: 10.1016/j.jacc.2013.06.059. Epub 2013 Sep 4. No abstract available.
PubMed 24013049Spallarossa P, Guerrini M, Arboscello E, Sicbaldi V. Enalapril and carvedilol for preventing chemotherapy-induced left ventricular systolic dysfunction. J Am Coll Cardiol. 2013 Dec 24;62(25):2451-2452. doi: 10.1016/j.jacc.2013.07.077. Epub 2013 Sep 4. No abstract available.
PubMed 24013048Smiseth OA, Edvardsen T, Skulstad H. Cardioprotection during chemotherapy: need for faster transfer of knowledge from cardiology to oncology and role for a cardio-oncologist. J Am Coll Cardiol. 2013 Jun 11;61(23):2363-4. doi: 10.1016/j.jacc.2013.02.073. Epub 2013 Apr 10. No abstract available.
PubMed 23583243Guglin M, Krischer J, Tamura R, Fink A, Bello-Matricaria L, McCaskill-Stevens W, Munster PN. Randomized Trial of Lisinopril Versus Carvedilol to Prevent Trastuzumab Cardiotoxicity in Patients With Breast Cancer. J Am Coll Cardiol. 2019 Jun 11;73(22):2859-2868. doi: 10.1016/j.jacc.2019.03.495.
PubMed 31171092Gulati G, Heck SL, Ree AH, Hoffmann P, Schulz-Menger J, Fagerland MW, Gravdehaug B, von Knobelsdorff-Brenkenhoff F, Bratland A, Storas TH, Hagve TA, Rosjo H, Steine K, Geisler J, Omland T. Prevention of cardiac dysfunction during adjuvant breast cancer therapy (PRADA): a 2 x 2 factorial, randomized, placebo-controlled, double-blind clinical trial of candesartan and metoprolol. Eur Heart J. 2016 Jun 1;37(21):1671-80. doi: 10.1093/eurheartj/ehw022. Epub 2016 Feb 21.
PubMed 26903532Kalay N, Basar E, Ozdogru I, Er O, Cetinkaya Y, Dogan A, Inanc T, Oguzhan A, Eryol NK, Topsakal R, Ergin A. Protective effects of carvedilol against anthracycline-induced cardiomyopathy. J Am Coll Cardiol. 2006 Dec 5;48(11):2258-62. doi: 10.1016/j.jacc.2006.07.052. Epub 2006 Nov 9.
PubMed 17161256Shah P, Garris R, Abboud R, Vasudev R, Patel H, Doshi R, Shamoon F, Bikkina M. Meta-Analysis Comparing Usefulness of Beta Blockers to Preserve Left Ventricular Function During Anthracycline Therapy. Am J Cardiol. 2019 Sep 1;124(5):789-794. doi: 10.1016/j.amjcard.2019.05.046. Epub 2019 Jun 6.
PubMed 31307662Wittayanukorn S, Qian J, Westrick SC, Billor N, Johnson B, Hansen RA. Prevention of Trastuzumab and Anthracycline-induced Cardiotoxicity Using Angiotensin-converting Enzyme Inhibitors or beta-blockers in Older Adults With Breast Cancer. Am J Clin Oncol. 2018 Sep;41(9):909-918. doi: 10.1097/COC.0000000000000389.
PubMed 28537988
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine Versus Beta-blockers, Angiotensin-converting Enzyme Inhibitors, and Statins for Prevention of Chemotherapy-Induced Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06304896
- Acronym / sponsor ID
- BASiC-CIC / #18240343
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Arab Contractors Medical CentreUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 evidence/opinion 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 patient's heart from the toxic effects of the chemotherapeutic intervention is unclear.
Additionally, The 2022 ACC/AHA/HFSA American guidelines recommend that in asymptomatic patients with cancer therapy-related cardiomyopathy (ejection fraction<50%), angiotensin-receptor blocker (ARBs)and 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 ACEi/ARB 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 and/or 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 0.5 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 test/NT-proBNP followed by serial testing every 2 months for a total of 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Cardioprotective Group (CPG) | Active comparator | Drug: Carvedilol, Drug: Ramipril, Drug: Rosuvastatin50 patients will receive a low-dose Beta-blockers in the form of Carvedilol 6.25 mg PO twice daily, a low-dose ACE inhibitors in the form of Ramipril 2.5 mg PO once daily, and a statin in the form of rosuvastatin 20 mg oral tablets. |
| The Immunomodulatory Group (IMG) | Active comparator | Drug: Colchicine50 patients will receive Colchicine 0.6 PO once daily. |
| The Placebo Control Group (PCG) | Placebo comparator | Drug: Placebo50 patients will receive a placebo as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing and able to provide written informed consent prior to performing study procedures.
- A cancer patient who is a candidate for a guideline-directed, anthracycline-based chemotherapy with or without the anti-HER2 trastuzumab.
- Baseline LVEF ≥ 50% without evident structural heart disease by pre-treatment echocardiographic examination.
Key exclusion criteria (12 listed)
- Critically ill Cancer patients who are admitted to ICU.
- Ischemic cardiomyopathy with LVEF ≤ 50%.
- Dilated cardiomyopathy with LVEF ≤ 50%.
- Advanced valvular heart disease (severe valvular affection in the form of stenosis or regurgitation).
- Systolic BP < 90 mmHg or diastolic BP < 60 mmHg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarvedilolAlso: Carvid, CoregCarvedilol 6.25 mg oral tablets. Prescribed: Twice daily PO with 200 mL of water. | Drug | The Cardioprotective Group (CPG) |
| RamiprilAlso: Tritace, AltaceRamipril 2.5 mg oral capsules. Prescribed: Once daily PO with 200 mL of water. | Drug | The Cardioprotective Group (CPG) |
| RosuvastatinAlso: CrestorRosuvastatin 20 mg oral tablets. Prescribed: Once daily PO with 200 mL of water. | Drug | The Cardioprotective Group (CPG) |
| ColchicineAlso: Colcrys, MitigareColchicine 0.6 mg oral tablets/capsules. Prescribed: Once daily PO with 200 mL of water. | Drug | The Immunomodulatory Group (IMG) |
| PlaceboPlacebo oral capsules. Prescribed: Once daily PO with 200 mL of water. | Drug | The Placebo Control Group (PCG) |
Primary outcome
Chemotherapy-induced cardiomyopathy
Time frame: 6 months
An identification of a drop in the LVEF using echocardiography more than or equal to 10% from the baseline at the time of presentation and/or a decline of the LVEF less than 50%.
Chemotherapy-induced cardiomyopathy
Time frame: 6 months
An identification of at least one value of serum NT-proBNP over 125 pg/mL in patients less than 75 years of age, or 450pg/mL in patients more than 75 years of age.
2 secondary outcomes
Major Adverse Cardiovascular Events
Time frame: 6 months
All-Cause Mortality
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 35766262Sun X, Duan J, Gong C, Feng Y, Hu J, Gu R, Xu B. Colchicine Ameliorates Dilated Cardiomyopathy Via SIRT2-Mediated Suppression of NLRP3 Inflammasome Activation. J Am Heart Assoc. 2022 Jul 5;11(13):e025266. doi: 10.1161/JAHA.122.025266. Epub 2022 Jun 29.
- Background: PubMed 35046517Zhang FS, He QZ, Qin CH, Little PJ, Weng JP, Xu SW. Therapeutic potential of colchicine in cardiovascular medicine: a pharmacological review. Acta Pharmacol Sin. 2022 Sep;43(9):2173-2190. doi: 10.1038/s41401-021-00835-w. Epub 2022 Jan 19.
- Background: PubMed 26683907Kuo MC, Chang SJ, Hsieh MC. Colchicine Significantly Reduces Incident Cancer in Gout Male Patients: A 12-Year Cohort Study. Medicine (Baltimore). 2015 Dec;94(50):e1570. doi: 10.1097/MD.0000000000001570.
- Background: PubMed 30429232Zhang T, Chen W, Jiang X, Liu L, Wei K, Du H, Wang H, Li J. Anticancer effects and underlying mechanism of Colchicine on human gastric cancer cell lines in vitro and in vivo. Biosci Rep. 2019 Jan 15;39(1):BSR20181802. doi: 10.1042/BSR20181802. Print 2019 Jan 31.
- Background: PubMed 35083827Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.
- Background: PubMed 35363499Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
- Background: PubMed 23583763Bosch X, Rovira M, Sitges M, Domenech A, Ortiz-Perez JT, de Caralt TM, Morales-Ruiz M, Perea RJ, Monzo M, Esteve J. Enalapril and carvedilol for preventing chemotherapy-induced left ventricular systolic dysfunction in patients with malignant hemopathies: the OVERCOME trial (preventiOn of left Ventricular dysfunction with Enalapril and caRvedilol in patients submitted to intensive ChemOtherapy for the treatment of Malignant hEmopathies). J Am Coll Cardiol. 2013 Jun 11;61(23):2355-62. doi: 10.1016/j.jacc.2013.02.072. Epub 2013 Apr 10.
- Background: PubMed 24013049Golwala H. Enalapril/carvedilol for prevention of chemotherapy-induced heart failure: an end to the problem. J Am Coll Cardiol. 2013 Dec 24;62(25):2450-2451. doi: 10.1016/j.jacc.2013.06.059. Epub 2013 Sep 4. No abstract available.
- Background: PubMed 24013048Spallarossa P, Guerrini M, Arboscello E, Sicbaldi V. Enalapril and carvedilol for preventing chemotherapy-induced left ventricular systolic dysfunction. J Am Coll Cardiol. 2013 Dec 24;62(25):2451-2452. doi: 10.1016/j.jacc.2013.07.077. Epub 2013 Sep 4. No abstract available.
- Background: PubMed 23583243Smiseth OA, Edvardsen T, Skulstad H. Cardioprotection during chemotherapy: need for faster transfer of knowledge from cardiology to oncology and role for a cardio-oncologist. J Am Coll Cardiol. 2013 Jun 11;61(23):2363-4. doi: 10.1016/j.jacc.2013.02.073. Epub 2013 Apr 10. No abstract available.
- Background: PubMed 31171092Guglin M, Krischer J, Tamura R, Fink A, Bello-Matricaria L, McCaskill-Stevens W, Munster PN. Randomized Trial of Lisinopril Versus Carvedilol to Prevent Trastuzumab Cardiotoxicity in Patients With Breast Cancer. J Am Coll Cardiol. 2019 Jun 11;73(22):2859-2868. doi: 10.1016/j.jacc.2019.03.495.
- Background: PubMed 26903532Gulati G, Heck SL, Ree AH, Hoffmann P, Schulz-Menger J, Fagerland MW, Gravdehaug B, von Knobelsdorff-Brenkenhoff F, Bratland A, Storas TH, Hagve TA, Rosjo H, Steine K, Geisler J, Omland T. Prevention of cardiac dysfunction during adjuvant breast cancer therapy (PRADA): a 2 x 2 factorial, randomized, placebo-controlled, double-blind clinical trial of candesartan and metoprolol. Eur Heart J. 2016 Jun 1;37(21):1671-80. doi: 10.1093/eurheartj/ehw022. Epub 2016 Feb 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eslam Abbas, MBChB, MSc principal investigator
Arab Contractors Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carvedilol, Ramipril and Rosuvastatin in people with Chemotherapy Induced Systolic Dysfunction, run by Arab Contractors Medical Centre at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eslam Abbas, MBChB, MSc (01023054574 ext. +2, islam.omr@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy-induced cardiomyopathy (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06304896, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.