What side effects are associated with this type of intervention?

Common treatments for Congenital Heart Disease (CHD) include medications, surgical interventions, and physical therapy programs such as passive range of motion (ROM) exercises. Medications like diuretics, ACE inhibitors, and beta-blockers can cause side effects such as electrolyte imbalances, hypotension, and fatigue. Surgical interventions, while often necessary, carry risks of infection, bleeding, and arrhythmias. Passive ROM exercise programs, aimed at improving physical function and cardiovascular outcomes, are generally safe but may cause temporary muscle soreness or fatigue. Overall, the side effects vary depending on the specific treatment modality used.

What prior FDA approvals exist?

The FDA has approved several treatments for Congenital Heart Disease (CHD), including medications and surgical interventions. Medications such as sildenafil have been used to manage pulmonary arterial hypertension in pediatric patients with CHD, improving exercise capacity and cardiovascular function. Additionally, surgical procedures like the Norwood procedure are critical for managing complex CHD conditions such as Hypoplastic Left Heart Syndrome (HLHS). While the passive ROM exercise program is not a drug, it aims to improve physical function and potentially cardiovascular outcomes in infants with CHD, similar to how medications and surgeries aim to enhance overall heart function and patient quality of life.

What other types of research exist?

Promising novel alternatives to Passive ROM Exercise Program for Congenital Heart Disease patients include: 1) High-Intensity Interval Training (HIIT), which has shown benefits in improving cardiovascular fitness and physical function. 2) Supervised Exercise Therapy (SET), which combines structured exercise with professional supervision to enhance outcomes. 3) Advanced strength training programs tailored to pediatric patients, which can improve muscle function and overall physical health. 4) Emerging pharmacotherapies targeting specific cardiovascular improvements in CHD patients, such as novel vasodilators or metabolic modulators.

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Exercise Therapy for Hypoplastic Left Heart Syndrome (T4G RCT Trial)

Phase 3

Waitlist Available

Research Sponsored by HealthCore-NERI

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized infants with HLHS or other single RV anomalies

Planned Norwood procedure

Must not have

Non-cardiac diagnosis associated with growth failures

Chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan, or Turner syndromes)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months of age or superior cavopulmonary connection (scpc) evaluation clinic visit, whichever comes first

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a gentle exercise program for babies with serious heart conditions who have had a specific surgery. The exercises involve moving the baby's arms and legs to help them grow better. This could also help their brain development and reduce their hospital stay.

Who is the study for?

This trial is for hospitalized infants with heart conditions like HLHS or single right ventricle anomalies, who are full-term (>=37 weeks), under 30 days old, and scheduled for the Norwood procedure. Parents must agree to follow the study rules and give consent. Infants with very low birth weight, certain genetic syndromes, non-cardiac growth issues, those listed for a transplant or expected to be discharged within two weeks of screening can't join.

What is being tested?

The TEAM 4 Growth RCT is testing a passive range of motion exercise therapy program on infants after they've had heart surgery called the Norwood procedure. It's designed to see if this therapy helps in their recovery and growth post-surgery.

What are the potential side effects?

Since it involves gentle exercises done by a therapist without active effort from the infant, side effects might be minimal but could include mild discomfort or fatigue during or after therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My infant is hospitalized with a single ventricle heart condition.

Select...

I am scheduled for a Norwood heart surgery.

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I am less than 30 days old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My condition, not related to my heart, is causing growth issues.

Select...

I have a genetic condition like Trisomy, Noonan, or Turner syndromes affecting my growth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months of age or superior cavopulmonary connection (scpc) evaluation clinic visit, whichever comes first

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months of age or superior cavopulmonary connection (scpc) evaluation clinic visit, whichever comes first

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months of age or superior cavopulmonary connection (scpc) evaluation clinic visit, whichever comes first for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

weight-for-age z-score

Secondary study objectives

DXA

Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) subdomain scores

Tests of Infant Motor Performance (TIMP)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Passive range-of-motionExperimental Treatment1 Intervention

daily assisted exercise sessions lasting 15-20 minutes, conducted by trained physical therapists, for up to 21 days prior to hospital discharge, plus standard of care

Group II: Standard of careActive Control1 Intervention

standard of care at study site

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Congenital Heart Disease (CHD) include surgical interventions, catheter-based procedures, and pharmacological therapies. Surgical interventions, such as the Norwood procedure, aim to correct structural heart defects to improve blood flow and oxygenation. Catheter-based procedures, like balloon angioplasty, help to open narrowed blood vessels, enhancing circulation. Pharmacological therapies, including diuretics and beta-blockers, manage symptoms by reducing fluid overload and controlling heart rate. Passive Range of Motion (ROM) exercise programs, as studied in trials, improve physical function and potentially cardiovascular outcomes by enhancing muscle strength and circulation, which is crucial for CHD patients to maintain overall health and reduce the risk of complications.

Importance of characteristics and modalities of physical activity and exercise in the management of cardiovascular health in individuals with cardiovascular disease (Part III).