Cardiovascular Function in Acute Leukemia

NCT03760237 | Completed

• 1 other identifier: UPCC48418
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Leukemia, Myeloid, Acute; Leukemia, Lymphoid, Acute; Cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• Left Ventricular dysfunction

  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 Outcomes (3)

• Incidence of Cardiovascular Events

  1 year

• Incidence of Symptomatic Heart Failure

  1 year

• Incidence of Cardiac Death and all mortality

  1 year

Study Arms (1)

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

Interventions

observation only OTHER

No intervention, observational study only

Acute Leukemia

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are newly diagnosed with acute leukemia

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Cardiotoxicity

Condition Hierarchy (Ancestors)

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

Study Officials

• Marielle Scherrer-Crosbie, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: November 30, 2018
• Study Start: December 10, 2018
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-05

Locations

US (1)