Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study

City of Hope

Status: Active, not recruiting

Conditions: Plasma Cell Myeloma; Hodgkin Lymphoma; Hematopoietic and Lymphoid Cell Neoplasm; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Non-Hodgkin Lymphoma; Acute Myeloid Leukemia

Treatments: Other: Questionnaire Administration; Procedure: Ultrasound; Procedure: Echocardiography; Procedure: Physical Performance Testing; Procedure: Bioelectric Impedance Analysis; Procedure: Biospecimen Collection; Procedure: Pulmonary Function Test; Procedure: Cardiopulmonary Exercise Testing

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04537871

19424 (Other Identifier)

P30CA033572 (U.S. NIH Grant/Contract)

NCI-2020-06749 (Registry Identifier)

R01HL150069 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

350 participants in 1 patient group

Observational (physical assessment)

Description:

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.

Treatment:

Procedure: Cardiopulmonary Exercise Testing

Procedure: Pulmonary Function Test

Procedure: Biospecimen Collection

Procedure: Bioelectric Impedance Analysis

Procedure: Physical Performance Testing

Procedure: Echocardiography

Procedure: Ultrasound

Other: Questionnaire Administration