Cardiovascular Function in Acute Leukemia

Leukemia, Myeloid, Acute Clinical Trial

Official title:

Cardiovascular Function in Leukemia Patients: an Observational Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03760237
• Other study ID #: UPCC48418
• Status: Completed
• Start date: December 10, 2018
• Est. completion date: May 6, 2024

Study information

• Verified date: May 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 6, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiotoxicity
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Lymphoid, Acute
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• observation only
No intervention, observational study only

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Cardiovascular Events		1 year
Secondary	Incidence of Symptomatic Heart Failure		1 year
Secondary	Incidence of Cardiac Death and all mortality		1 year