Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study

Acute Myeloid Leukemia Clinical Trial

Official title:

Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04537871
• Other study ID #: 19424
• Secondary ID: NCI-2020-0674919
• Status: Recruiting
• Start date: November 18, 2020
• Est. completion date: December 4, 2024

Study information

• Verified date: May 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates how well the heart, lungs, and muscles are working individually, and how these systems are working together in transplant survivors. Information collected in this study may help doctors to understand why hematopoietic stem cell transplant survivors are at higher risk for developing cardiovascular disease.

Description:

PRIMARY OBJECTIVES:

I. Evaluate cardiovascular reserve capacity, as measured by peak oxygen consumption (VO2peak), in hematopoietic cell transplantation (HCT) survivors.

II. Define the determinants of VO2peak impairment in HCT survivors.

OUTLINE:

Patients undergo echocardiogram to assess cardiac function and mechanics, cardiopulmonary exercise test, pulmonary function test, musculoskeletal ultrasound, bioelectrical impedance analysis to measure total lean body mass and percent body fat), physical function tests, and collection of blood samples within 45 days from the start of conditioning therapy, and at 6 months, 1 year, and 2 years post-transplant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 4, 2024
• Est. primary completion date: December 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age at HCT >= 18 years

• Diagnosis of acute leukemia (myeloid, lymphoid), lymphoma (non-Hodgkin, Hodgkin), multiple myeloma or myelodysplastic syndromes

• Planning to undergo first autologous or allogeneic transplant

• Able to fluently read and write in English

• Able to understand and sign the study specific informed consent form (ICF)

• Physically able and willing to complete all study procedures

Exclusion Criteria:

• Unstable bone lesions per electronic medical record review and/or notification from patient's primary physician

• Unstable angina or history of acute myocardial Infarction (< 5 days of any planned study procedures)

• Recurrent syncope

• Acute myocarditis or pericarditis

• Symptomatic severe aortic stenosis

• Uncontrolled arrhythmia causing symptoms

• Pulmonary embolus < 3 month of study procedures

• Thrombosis of lower extremities

• Moderate or severe persistent asthma (National Asthma Education & Prevention)

• Room air desaturation at rest =< 85%

• Non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)

• Anemia (hemoglobin [Hgb] < 8 g/dL)

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Hematopoietic and Lymphoid Cell Neoplasm
• Hodgkin Lymphoma
• Leukemia
• Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Non-Hodgkin Lymphoma
• Plasma Cell Myeloma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Procedure:
• Bioelectric Impedance Analysis
Undergo bioelectric impedance analysis
• Biospecimen Collection
Undergo collection of blood samples
• Cardiopulmonary Exercise Testing
Undergo cardiopulmonary exercise test
• Echocardiography
Undergo echocardiogram
• Physical Performance Testing
Undergo physical function tests
• Pulmonary Function Test
Undergo pulmonary function test

Other:
• Questionnaire Administration
Ancillary studies

Procedure:
• Ultrasound
Undergo musculoskeletal ultrasound

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (3)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular reserve capacity, as measured by VO2peak, in HCT survivors	We will measure initial VO2peak in patients prior to HCT and its post-HCT trajectory over time; compare VO2peak in HCT survivors at baseline (pre-HCT), 6m, 1Y, and 2Y post-HCT to established age- and sex-normative data; and define the association between VO2peak and self-reported health-related quality of life (HRQOL) at baseline/over time.	Up to 24 months post-hematopoietic cell transplantation (HCT)
Primary	Determinants of VO2peak impairment in HCT survivors	We will use Generalized Estimating Equation(GEE) and generalized linear models to examine the correlation between VO2peak and measures of: cardiac (left ventricular function/ contractility [systolic, diastolic, cardiac output, strain], ventricular-arterial (VA) coupling, arterial elastance); pulmonary (obstructive, restrictive lung disease, diffusion capacity); musculoskeletal (body composition [% lean muscle mass], muscle quality, two minute step in place test, 30 second sit to stand test, timed up and go); and; hematologic function, adjusting for potential confounding variables (e.g. age, sex) and time since HCT.	Up to 24 months post-hematopoietic cell transplantation (HCT)