Program to enhance heart health in patients getting stem cell transplants
Cardio-Oncology Prehabilitation Program to Improve Cardiac Reserve in High-Risk Patients Undergoing Hematopoietic Stem Cell Transplantation
This study tests a heart health program for patients with cardiovascular risks who are getting stem cell transplants to see if it helps them get fitter and avoid heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05945121 on ClinicalTrials.gov |
What this trial studies
This study evaluates a Cardio-Oncology Prehabilitation program aimed at improving cardiorespiratory fitness and reducing cardiovascular complications in high-risk patients undergoing hematopoietic stem cell transplantation. It focuses on patients with existing cardiovascular risk factors and assesses the feasibility and preliminary effectiveness of the intervention. Participants will engage in a structured program designed to enhance their cardiovascular health before the transplant procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are referred for hematopoietic stem cell transplantation and have at least one cardiovascular risk factor.
Not a fit: Patients with severe cardiovascular conditions or those unable to ambulate unassisted may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve heart health and reduce complications for patients undergoing stem cell transplants.
How similar studies have performed: Other studies have shown promising results with prehabilitation programs in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult 18 years or older * Referred for HSCT evaluation * Presence of least one CV risk factor at enrollment (hypertension, hyperlipidemia, atrial fibrillation, obesity, heart failure, history of coronary artery disease, diabetes) * Able to ambulate unassisted * Ability to understand and the willingness to sign a written informed consent * Ability to use Polar Flow heart rate application Exclusion Criteria: * Severe anemia (hemoglobin \<7 gm/dl) * Untreated high-risk coronary artery disease (left main, triple vessel disease) * Severe aortic stenosis * Recent fracture as assessed via self-report * Gross balance deficits * Severe pain with basic movement * Unable to ambulate unassisted or exercise * NYHA class IV heart failure * Adults unable to give consent, pregnant women, and prisoners are excluded from this study.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Salim Hayek — University of Michigan Rogel Cancer Center
- Study coordinator: Cancer AnswerLine
- Email: CancerAnswerLine@med.umich.edu
- Phone: 1-800-865-1125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.