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New treatment option for Heart Failure
Official title The HIMALAYAS Trial and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05023785
What this study is testing
- What it's testing
- Pediatric, adolescent and young adult cancer survivors (PAYA-CS) are at higher risk of cardiovascular (CV) morbidity and mortality. This is a consequence of prior cancer-related therapies that have the potential of producing cardiac dysfunction, reducing cardiorespiratory fitness (reduced VO2peak) and psychosocial morbidities (i.e., anxiety and depression).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- Be a PAYA-CS, defined as ≤39 years of age at the time of cancer diagnosis;
- Be 18-45 years of age at the time of enrolment;
- Received cancer treatment(s) with known cardiovascular risks (e.g., anthracyclines, trastuzumab, radiotherapy, platinum-based agents, vascular...
- Be cancer-free at the time of enrollment;
- Stage B Heart Failure (SBHF)
You likely can't join if
- Have an absolute or unresolved relative contraindication to exercise according to the American College of Sports Medicine guidelines;
- Have an untreated physical or mental health concern that precludes safe and effective exercise participation;
- Have established CVD (excluding mildly reduced LVEF as described above);
- Be pregnant at time of recruitment;
- Be currently engaging in frequent high-intensity exercise (\>1 high-intensity exercise session per week);
- Have substantial barriers to participating, including (1) living too far from study centre or (2) being unable or willing to comply with the study...
See the full eligibility criteria
- Be a PAYA-CS, defined as ≤39 years of age at the time of cancer diagnosis;
- Be 18-45 years of age at the time of enrolment;
- Received cancer treatment(s) with known cardiovascular risks (e.g., anthracyclines, trastuzumab, radiotherapy, platinum-based agents, vascular endothelial growth factor inhibitors, tyrosine kinase inhibitors);
- Be cancer-free at the time of enrollment;
- Stage B Heart Failure (SBHF)
- In patients with availability of pre-treatment imaging:
- ≥10% decrease in LVEF at post-treatment compared to pre-treatment
- ≥15% decrease in GLS at post-treatment compared to pre-treatment
- No pre-treatment imaging:
- LVEF ≤53% in women/51% in men
- GLS \>-18%
- Left ventricular hypertrophy (LV mass/body surface area: \>95 g/m2 for women or \>115 g/m2 for men)
- Concentric remodelling (\>0.42 relative wall thickness)
- Diastolic dysfunction (≥ grade 1)
- BNP ≥35pg/ml or NT-proBNP ≥125pg/ml
- Have an absolute or unresolved relative contraindication to exercise according to the American College of Sports Medicine guidelines;
- Have an untreated physical or mental health concern that precludes safe and effective exercise participation;
- Have established CVD (excluding mildly reduced LVEF as described above);
- Be pregnant at time of recruitment;
- Be currently engaging in frequent high-intensity exercise (\>1 high-intensity exercise session per week);
- Have substantial barriers to participating, including (1) living too far from study centre or (2) being unable or willing to comply with the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.