Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study

NCT04537871 | Active Not Recruiting

• 4 other identifiers: 19424NCI-2020-06749P30CA033572R01HL150069
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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: 1. cardiac (left ventricular function/ contractility \[systolic, diastolic, cardiac output, strain\], ventricular-arterial (VA) coupling, arterial elastance); 2. pulmonary (obstructive, restrictive lung disease, diffusion capacity); 3. 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 4. hematologic function, adjusting for potential confounding variables (e.g. age, sex) and time since HCT.

  Up to 24 months post-hematopoietic cell transplantation (HCT)

Study Arms (1)

Observational (physical assessment)

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.

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

Interventions

Bioelectric Impedance Analysis PROCEDURE

Undergo bioelectric impedance analysis

Also known as: BIA, Bioelectric Impedance, Bioelectric Impedance Test, Bioelectrical Impedance Analysis, Bioimpedance Analysis

Observational (physical assessment)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Observational (physical assessment)

Cardiopulmonary Exercise Testing PROCEDURE

Undergo cardiopulmonary exercise test

Also known as: CPET, CPX

Observational (physical assessment)

Echocardiography PROCEDURE

Undergo echocardiogram

Observational (physical assessment)

Physical Performance Testing PROCEDURE

Undergo physical function tests

Also known as: Physical Fitness Testing, Physical Function Testing

Observational (physical assessment)

Pulmonary Function Test PROCEDURE

Undergo pulmonary function test

Also known as: lung function test, PFT, Pulmonary Function Testing, Pulmonary Function Tests

Observational (physical assessment)

Questionnaire Administration OTHER

Ancillary studies

Observational (physical assessment)

Ultrasound PROCEDURE

Undergo musculoskeletal ultrasound

Observational (physical assessment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute leukemia (myeloid, lymphoid), lymphoma (non-Hodgkin, Hodgkin), multiple myeloma or myelodysplastic syndromes

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Hematologic Neoplasms; Hodgkin Disease; Myelodysplastic Syndromes; Lymphoma, Non-Hodgkin; Multiple Myeloma

Interventions

Exercise Test; Clostridium perfringens epsilon-toxin; Respiratory Physiological Phenomena; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Neoplasms by Site; Lymphoma; Bone Marrow Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Circulatory and Respiratory Physiological Phenomena; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Saro H Armenian

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 3, 2020
• Study Start: November 18, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

US (1)