Cardiovascular Function in Acute Leukemia

Completed

• Conditions: Leukemia, Lymphoid, Acute; Cardiotoxicity; Leukemia, Myeloid, Acute
• Interventions: Other: observation only

• Registration Number: NCT03760237
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-11-29
• Study First Posted: 2018-11-30
• Study Start: 2018-12-10
• Status Verified: 2024-05
• Primary Completion: 2024-05-06
• Study Completion: 2024-05-06
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute Leukemia	observation only	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.

Primary Outcome Measures

Name	Time	Method
Left Ventricular dysfunction	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 Outcome Measures

Name	Time	Method
Incidence of Cardiovascular Events	1 year
Incidence of Symptomatic Heart Failure	1 year
Incidence of Cardiac Death and all mortality	1 year

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States