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NCT Number: NCT04537871

Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bioelectric Impedance Analysis

Procedure

Undergo bioelectric impedance analysis

Other names: BIA, Bioelectric Impedance, Bioelectric Impedance Test, Bioelectrical Impedance Analysis, Bioimpedance Analysis

Biospecimen Collection

Procedure

Undergo collection of blood samples

Cardiopulmonary Exercise Testing

Procedure

Undergo cardiopulmonary exercise test

Other names: CPET, CPX

Echocardiography

Procedure

Undergo echocardiogram

Physical Performance Testing

Procedure

Undergo physical function tests

Other names: Physical Fitness Testing, Physical Function Testing

Pulmonary Function Test

Procedure

Undergo pulmonary function test

Other names: lung function test, PFT, Pulmonary Function Testing, Pulmonary Function Tests

Questionnaire Administration

Other

Ancillary studies

Ultrasound

Procedure

Undergo musculoskeletal ultrasound

Primary outcomes

  1. Cardiovascular reserve capacity, as measured by VO2peak, in HCT survivors

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

    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.

  2. Determinants of VO2peak impairment in HCT survivors

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

    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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST)

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2020
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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