Kansas City, MONCT06015191Now EnrollingIRB Ready

Congenital Heart Disease in Children Clinical Trial in Kansas City, MO

Access cutting-edge congenital heart disease in children treatment through this clinical trial at a research site in Kansas City. Study-provided care at no cost to qualified participants.

Sponsored by Children's Mercy Hospital Kansas City

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Expert Care in Kansas City

Access congenital heart disease in children specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related congenital heart disease in children treatment provided free

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Why Participate?

  • No-Cost Study Care

  • Local to Kansas City

    Convenient for MO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Kansas City site if eligible
  4. 4Begin participation

About This Congenital Heart Disease in Children Study in Kansas City

The goal of this randomized controlled trial is to evaluate the effectiveness of video conferencing for the delivery of live-supervised, real-time cardiac rehabilitation (CR) exercise training to groups of adolescents with congenital heart disease (CHD) in their homes. Participants will be randomized to either the remote cardiac rehab (RCR) group or active control group. The RCR group will participate in live, group-based exercise training (3-5 participants per exercise session), in their homes 3 days per week for 45 minutes over 12-weeks. Exercise sessions will be led and supervised by a live health coach via telehealth video technology. The active control group will be provided informational handouts on health exercise for their cardiac diagnosis. The primary aim is to compare between group changes (0-12-weeks) in cardiorespiratory fitness (VO2peak). Secondary aims are to compare between group changes (0-12-weeks) in cardiac function (echocardiography), lean body mass, and physical frailty. Exploratory aims will compare between group changes (0-12-weeks) in physical function, quality of life, skeletal muscle function, and physical activity self-efficacy. Additionally, exploratory aims will explore the impact of demographic characteristics, program participation, program satisfaction, and daily physical activity on changes in cardiorespiratory fitness.

Sponsor: Children's Mercy Hospital Kansas City

Who Can Participate

Inclusion Criteria

Age 12-19 years old
Male or Female
Diagnosed with one of three congenital heart diseases: Univentricular heart with Fontan Palliation Tetralogy of Fallot with transannular patch Dextro-transposition of the great arteries with arterial switch operation
Primary Cardiology clearance for exercise participation
Internet access in their homes
Available for in-home exercise between 4-7pm on at least 3 days of the Monday-Friday work week
English Speaking
Achieving maximal effort on a cardiopulmonary exercise test, defined as RER ≥1.1 and/or in the judgement of the supervising exercise physiologist, a maximal effort was achieved but exercise capacity is limited by musculoskeletal deconditioning.

Exclusion Criteria

Physically or developmentally unable to perform outcomes assessments or participate in moderate-to-vigorous intensity physical activity
Participating in \> 15 MET-hours per week (mean weekly average over the past 12-months) of organized athletic/exercise activity (not including school physical education class).
Height less than 132cm
Pregnancy or planned surgery or procedure (excluding outpatient, non-cardiac procedures) within the 12-week study period.
Meeting at least 1 exercise test safety or screening criteria on most recent exercise test (pre-study) or baseline outcomes visit exercise test
Presence of significant cardiac dysfunction that would impair safe participation in moderate-to-vigorous intensity exercise
Significant changes baseline echocardiogram or most recent clinical echocardiogram (from past clinical echocardiogram) such as decrease in ventricular and/or valvar function, new obstruction, or any new structural abnormalities
Uncontrolled or poorly controlled asthma
Presence of implanted cardioverter-defibrillator
Pacemaker with rate-responsive function initiated
Reliance on ventricular assist device
Prescribed milrinone medication
Listed for heart transplantation
Active engagement in hormone replacement for gender transition

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Kansas City?

Yes, this clinical trial (NCT06015191) has an active research site in Kansas City, MO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Congenital Heart Disease in Children Treatment Options in Kansas City, MO

If you're searching for congenital heart disease in children treatment options in Kansas City, MO, this clinical trial (NCT06015191) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Kansas City research site is actively enrolling participants for this clinical trial. You'll receive care from experienced congenital heart disease in children specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all congenital heart disease in children clinical trials near you to find additional studies recruiting in your area.

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