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NCT04977180 · ClinicalTrials.gov registry record · Phase 2

Cardioprotection in AML

A Phase 2 study of Acute Myeloid Leukemia and AML, sponsored by University of Virginia.

Recruiting
Registry status
Phase 2
Development phase
70
Enrollment target
1
Study location

NCT04977180 is a Phase 2 study of Acute Myeloid Leukemia and AML that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 70 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04977180, a Phase 2 study of Acute Myeloid Leukemia and AML, is actively recruiting participants, sponsored by University of Virginia.

RECRUITING
Registry status
Phase 2
Development phase
70 participants
Enrollment target
1
Study location

Study Summary

Patients with acute myeloid leukemia (AML) often receive a drug called daunorubicin. Daunorubicin is a type of drug called an anthracycline, which increases the risk of some damage to the heart. Beta blockers and angiotensin-converting enzyme inhibitors (ACEi) are two types of drugs that are often used (and are FDA approved) to treat the type of damage to the heart caused by anthracyclines. They have also been used in some populations to prevent this type of heart damage. In this study, participants will be randomly assigned to either preventively take a beta blocker and ACEi or not to receive these. The primary purpose of the study is to look at how often people in each group develop this type of heart damage. The study investigators will also collect data about your quality of life and other changes in your heart function. Frequency and severity of anthracycline-induced cardiotoxicity among patients receiving acute myeloid leukemia (AML) chemotherapy is unknown. We hypothesize that up-titrating study agents to maximum tolerated dosage at the time of induction (starting treatment for AML) will prevent the development of systolic dysfunction as determined on serial echocardiography.

Conditions Studied

Acute Myeloid Leukemia AML

Interventions

  • DRUG Cardioprotection

Study Locations (1)

Virginia

  • University of Virginia - Charlottesville

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2022-03-04
Est. Completion 2028-09
Phase Phase 2

Sponsor

University of Virginia

449 total trials

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What the Registry Record Tells You About NCT04977180

The ClinicalTrials.gov registry entry for NCT04977180 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (40% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Cardioprotection is the first listed.

NCT04977180 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT04977180 about?

NCT04977180 is a clinical study titled "Cardioprotection in AML". Patients with acute myeloid leukemia (AML) often receive a drug called daunorubicin. Daunorubicin is a type of drug called an anthracycline, which increases the risk of some damage to the heart. Beta blockers and angiotensin-converting enzyme inhibitors (ACEi) are two types of drugs that are often u...

What is the current status of trial NCT04977180?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2022-03-04. Estimated completion is 2028-09.

What conditions does trial NCT04977180 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, AML.

What interventions are being tested in trial NCT04977180?

The interventions under investigation include: Cardioprotection (DRUG).

Who is sponsoring clinical trial NCT04977180?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04977180 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.