Cardiovascular Function in Acute Leukemia

July 25, 2023 updated by: Abramson Cancer Center at Penn Medicine

Cardiovascular Function in Leukemia Patients: an Observational Prospective Study

An observational, prospective study to describe the rates and predictors of cardiovascular events in patients with acute leukemia.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Patients recently diagnosed with acute leukemia and who will initiating chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year.

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who are newly diagnosed with acute leukemia

Description

Inclusion Criteria:

  • Older than 18 years of age,
  • New diagnosis of untreated acute leukemia (prior treatment for myelodysplastic syndrome or myeloproliferative neoplams or prior treatment with an anthracycline for breast cancer, Hodgkin's lymphoma, non-Hodgkin's lymphoma or another diagnosis will be included).
  • Signed the informed consent form

Exclusion Criteria:

• Unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Acute Leukemia
Observation only. Patients newly diagnosed with acute leukemia who are scheduled to start treatment with chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year.
Other: observation only
No intervention, observational study only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left Ventricular dysfunction
Time Frame: 1 year
defined as a reduction in Left Ventricular Ejection Fraction of more than 10 percentage points from baseline and to less than 50%.
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Cardiovascular Events
Time Frame: 1 year
1 year
Incidence of Symptomatic Heart Failure
Time Frame: 1 year
1 year
Incidence of Cardiac Death and all mortality
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2018

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

November 29, 2018

First Submitted That Met QC Criteria

November 29, 2018

First Posted (Actual)

November 30, 2018

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC48418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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