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Completed

NCT Number: NCT03760237

Cardiovascular Function in Acute Leukemia

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

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Key information

Conditions

Leukemia, Myeloid, Acute Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Lymphoid, Acute Leukemia, Myeloid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Radiation Injuries Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation only

Other

No intervention, observational study only

Primary outcomes

  1. 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%.

Secondary outcomes

  1. Incidence of Cardiovascular Events

    Time frame: 1 year

  2. Incidence of Symptomatic Heart Failure

    Time frame: 1 year

  3. Incidence of Cardiac Death and all mortality

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Cardiovascular Function in Leukemia Patients: an Observational Prospective Study

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 30, 2018
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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