Clinical trial NCT04537871: Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study
Official title: Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Hematopoietic and Lymphoid Cell Neoplasm
Hodgkin Lymphoma
Myelodysplastic Syndrome
Non-Hodgkin Lymphoma
Plasma Cell Myeloma
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-09-03
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute leukemia (myeloid, lymphoid), lymphoma (non-Hodgkin, Hodgkin), multiple myeloma or myelodysplastic syndromes

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cardiovascular reserve capacity, as measured by VO2peak, in HCT survivors
timeFrame: Up to 24 months post-hematopoietic cell transplantation (HCT)
measure: Determinants of VO2peak impairment in HCT survivors
timeFrame: Up to 24 months post-hematopoietic cell transplantation (HCT)
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Saro H Armenian
role: PRINCIPAL_INVESTIGATOR
References: