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Breast CarcinomaPhase 2NCT04190433

Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial

A Phase 2 study testing Carvedilol, Lisinopril and Pravastatin in people with Breast Carcinoma and Hematopoietic and Lymphoid Cell Neoplasm, run by Mayo Clinic.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carvedilol, Lisinopril and Pravastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Sep 2020to 18 Apr 2023
Phase
Phase 2
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

  • >= 18 years of age.
  • New diagnosis of reduced cardiac function.
  • Any prior anthracycline-based cancer therapy for hematological malignancy, breast cancer, or sarcoma.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

About this study

Official title: AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment (ATACAR) Trial

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Carvedilol, Lisinopril, Pravastatin, Spironolactone
Medical subject headings
Breast Neoplasms, Hematologic Neoplasms, Lymphoma, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarvedilolDrug

    Also called Coreg

    Given PO

  • LisinoprilDrug

    Also called N2-[(1S)-1-Carboxy-3-phenylpropyl]-L-lysyl-L-proline, Dihydrate, Prinivil, Zestril

    Given PO

  • PravastatinDrug

    Also called [1S-[1alpha(betaS*,deltaS*),2alpha,6alpha,8beta(R*),8aalpha]]-1,2,6,7,8,8a-Hexahydro-beta,!d,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-1-naphthaleneheptanoic Acid

    Given PO

  • SpironolactoneDrug

    Also called 17-Hydroxy-7alpha-mercapto-3-oxo-17alpha-pregn-4-ene-21-carboxylic Acid, gamma Lactone, Acetate, Aldactone, SC 9420, SPL

    Given PO

Study groups in NCT04190433
Study groupRoleWhat they receive
Group I (carvedilol, lisinopril)Active comparatorPatients receive carvedilol orally (PO) and lisinopril orally (PO), up-titrated to maximum tolerated doses as per standard clinical practice for 6 months.
Receives: Drug: Carvedilol; Drug: Lisinopril
Group II (pravastatin, spironolactone)ExperimentalPatients receive standard clinical practice therapy as in Group I. Patients also receive pravastatin PO and spironolactone PO for 6 months.
Receives: Drug: Carvedilol; Drug: Lisinopril; Drug: Pravastatin; Drug: Spironolactone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Delta change in left ventricular ejection fraction [LVEF])

    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.

    Measured: Baseline up to 6 months

Secondary outcomes (2)

  1. Cardiac function recovery rates between group 1 and group 2

    Incidence rates will be compared using a simple test for equality of binomial proportions (χ ^ 2 -test or Fisher Exact).

    Measured: Baseline up to 6 months

  2. Time to recovery of cardiac function between group 1 and group 2

    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.

    Measured: Baseline up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2019
  2. Study start1 Sep 2020
  3. Primary completion18 Apr 2023
  4. Study completion18 Apr 2023

Why it stopped: Administratively closed due to low/no accrual

Resources

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 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04190433
Sponsor's protocol ID
19-007547
Other IDs
NCI-2021-13928
Status last verified
May 2023
First submitted
5 Dec 2019
Last updated
24 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carvedilol, Lisinopril and Pravastatin in people with Breast Carcinoma and Hematopoietic and Lymphoid Cell Neoplasm, run by Mayo Clinic.

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 13 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: withdrawn, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delta change in left ventricular ejection fraction [LVEF]) (time frame: Baseline up to 6 months). 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 NCT04190433.

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 24 May 2023.

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