Clinical trial · Interventional
Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial
AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment (ATACAR) Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administratively closed due to low/no accrual
Summary
Brief summary (as posted)
This phase II trial compares two drug therapy plans for the correction of heart function changes (reduced ejection function) in patients who have undergone anthracycline-based treatment for lymphoma, sarcoma, or breast cancer. "Reduced ejection fraction" means the left ventricle of the heart is pumping a reduced blood volume with each heartbeat. Treatment is recommended, and the purpose of this research is to compare two different drug therapy plans (standard therapy with carvedilol and lisinopril and standard therapy with carvedilol and lisinopril plus pravastatin and spironolactone) and their effects on improvement of heart function. All of these drugs are heart medications, and carvedilol and lisinopril are commonly used to improve heart function. Adding pravastatin, a cholesterol lowering drug with additional beneficial effects on the cardiovascular system, and spironolactone, a water pill with additional beneficial effects on the cardiovascular system, may lead to even better (and faster) improvements in heart function.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carvedilol | Drug | — | UNRESOLVED |
| Lisinopril | Drug | — | UNRESOLVED |
| Pravastatin | Drug | — | UNRESOLVED |
| Spironolactone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group I (carvedilol, lisinopril)
- description
- Patients receive carvedilol orally (PO) and lisinopril orally (PO), up-titrated to maximum tolerated doses as per standard clinical practice for 6 months.
- interventionNames
- Drug: Carvedilol
- Drug: Lisinopril
- type
- EXPERIMENTAL
- label
- Group II (pravastatin, spironolactone)
- description
- Patients receive standard clinical practice therapy as in Group I. Patients also receive pravastatin PO and spironolactone PO for 6 months.
- interventionNames
- Drug: Carvedilol
- Drug: Lisinopril
- Drug: Pravastatin
- Drug: Spironolactone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available