- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04190433
Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial
AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment (ATACAR) Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To compare cardiac function changes (delta left ventricular ejection fraction [LVEF]) over six months in patients with a new diagnosis of reduced LVEF after anthracycline-based therapy for lymphoma randomized to either standard therapy (carvedilol and lisinopril) or standard therapy plus pravastatin and spironolactone.
SECONDARY OBJECTIVE:
I. To compare cardiac function recovery rates over six months in patients with a new diagnosis of reduced LVEF after anthracycline-based therapy for lymphoma, sarcoma, or breast cancer randomized to either standard therapy (carvedilol and lisinopril) or standard therapy plus pravastatin and spironolactone.
II. To compare the time to recovery of cardiac function in patients with a new diagnosis of reduced LVEF after anthracycline-based therapy for lymphoma, sarcoma, or breast cancer randomized to either standard therapy (carvedilol and lisinopril) or standard therapy plus pravastatin and spironolactone.
OUTLINE: Patients are randomized in to 1 of 2 groups.
GROUP I: Patients receive carvedilol orally (PO) and lisinopril orally (PO), up-titrated to maximum tolerated doses as per standard clinical practice for 6 months.
GROUP II: Patients receive standard clinical practice therapy as in Group I. Patients also receive pravastatin PO and spironolactone PO for 6 months.
After completion of study treatment, patients are followed up at the 6 month visit.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Sierra Slade
- Phone Number: 507-422-5433
- Email: Slade.Sierra@mayo.edu
Study Contact Backup
- Name: Trevor Stromme
- Phone Number: 507-293-2754
- Email: stromme.trevor@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- >= 18 years of age.
- New diagnosis of reduced cardiac function.
- Any prior anthracycline-based cancer therapy for hematological malignancy, breast cancer, or sarcoma.
Exclusion Criteria:
- History of heart failure (HF) of any class and type, or diagnosis of cardiomyopathy prior to anthracycline therapy.
- On active therapy with a fibrate, niacin or eplerenone, or statin.
- History of myopathy/rhabdomyolysis.
- History of statin intolerance.
- Active treatment for hyperlipidemia.
- History of gout.
- Active treatment for liver disease.
- Unexplained persistent elevations of serum transaminases (above upper limit of normal over two weeks).
- Pregnancy.
- Breast-feeding.
- Hyperkalemia (above upper limit of normal).
- Addison disease.
- Estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m^2.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group I (carvedilol, lisinopril)
Patients receive carvedilol orally (PO) and lisinopril orally (PO), up-titrated to maximum tolerated doses as per standard clinical practice for 6 months.
|
Given PO
Other Names:
Given PO
Other Names:
|
Experimental: Group II (pravastatin, spironolactone)
Patients receive standard clinical practice therapy as in Group I. Patients also receive pravastatin PO and spironolactone PO for 6 months.
|
Given PO
Other Names:
Given PO
Other Names:
Given PO
Other Names:
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delta change in left ventricular ejection fraction [LVEF])
Time Frame: Baseline up to 6 months
|
Will be a comparison of the average delta change in LVEF from start to six months of therapy between group 1 and 2 via an independent groups t-test or Wilcoxon as appropriate after testing distributional assumptions.
|
Baseline up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac function recovery rates between group 1 and group 2
Time Frame: Baseline up to 6 months
|
Incidence rates will be compared using a simple test for equality of binomial proportions (χ ^ 2 -test or Fisher Exact).
|
Baseline up to 6 months
|
Time to recovery of cardiac function between group 1 and group 2
Time Frame: Baseline up to 6 months
|
Will be a comparison of the average delta change in LVEF from start to six months of therapy between group 1 and 2 via an independent groups t-test or Wilcoxon as appropriate after testing distributional assumptions.
|
Baseline up to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joerg Herrmann, Mayo Clinic in Rochester
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Cardiomyopathies
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Antimetabolites
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Protective Agents
- Natriuretic Agents
- Cardiotonic Agents
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Membrane Transport Modulators
- Diuretics
- Hormone Antagonists
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Antioxidants
- Angiotensin-Converting Enzyme Inhibitors
- Mineralocorticoid Receptor Antagonists
- Diuretics, Potassium Sparing
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Pravastatin
- Spironolactone
- Carvedilol
- Lisinopril
Other Study ID Numbers
- 19-007547
- NCI-2021-13928 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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