Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study

Sponsor
City of Hope Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04537871
Collaborator
National Cancer Institute (NCI) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
350
Enrollment
1
Location
33.7
Anticipated Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • 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

Detailed Description

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

  2. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
350 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST)
Actual Study Start Date :
Nov 18, 2020
Anticipated Primary Completion Date :
Sep 9, 2023
Anticipated Study Completion Date :
Sep 9, 2023

Arms and Interventions

ArmIntervention/Treatment
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
Undergo bioelectric impedance analysis
Other Names:
  • BIA
  • Bioelectric Impedance
  • Bioelectric Impedance Test
  • Bioelectrical Impedance Analysis
  • Bioimpedance Analysis
  • Procedure: Biospecimen Collection
    Undergo collection of blood samples

    Procedure: Cardiopulmonary Exercise Testing
    Undergo cardiopulmonary exercise test
    Other Names:
  • CPET
  • CPX
  • Procedure: Echocardiography
    Undergo echocardiogram

    Procedure: Physical Performance Testing
    Undergo physical function tests
    Other Names:
  • Physical Fitness Testing
  • Physical Function Testing
  • Procedure: Pulmonary Function Test
    Undergo pulmonary function test
    Other Names:
  • lung function test
  • PFT
  • Pulmonary Function Testing
  • Pulmonary Function Tests
  • Other: Questionnaire Administration
    Ancillary studies

    Procedure: Ultrasound
    Undergo musculoskeletal ultrasound

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1City of Hope Comprehensive Cancer CenterDuarteCaliforniaUnited States91010

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Saro H Armenian, City of Hope Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT04537871
    Other Study ID Numbers:
    • 19424
    • NCI-2020-06749
    • 19424
    • P30CA033572
    • R01HL150069
    First Posted:
    Sep 3, 2020
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 9, 2022