A Prospective Study of Patients With Hypoplastic Left Heart Syndrome (HLHS) Following Stage II Surgical Palliation



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:4/5/2019
Start Date:October 2012
End Date:November 2020
Contact:Karen S Miller
Email:miller.karen1@mayo.edu
Phone:507-266-5510

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Hypoplastic left heart syndrome (HLHS) is a severe form of congenital heart disease that
consists of multiple obstructions to flow through the left heart and aorta, as well as
hypoplasia of the left ventricle. Most patients require a three-stage surgical protocol
starting within days of birth. Stage I of this process is the Norwood reconstruction (within
the first few days of life), Stage II (usually required within 3-8 months) involves creation
of a direct connection between the patient's superior vena cava and the pulmonary arterial
confluence (bidirectional Glenn anastomosis), and the last stage is creation of a Fontan
circulation (typically within the first 2-4 years). This "single ventricle" approach requires
the right ventricle to perform as the only circulatory pump for the entire body.

Our long-term goal is to develop regenerative strategies to strengthen and augment the right
ventricular muscle of the single-ventricle heart following surgical palliation in HLHS
patients. To determine the safety and feasibility of a cell-based therapeutic intervention at
the Stage II surgery, we aim to document the natural history of post-surgical care in HLHS
patients having undergone standard of care with protocol specific follow-up over the course
of a 6-month period.

This prospective study will document the natural history in patients with HLHS after planned
Stage II surgical palliation with a focus on cardiovascular parameters within 6 months
following surgery in 10 patients.


Inclusion Criteria:

- Individuals with HLHS having undergone Stage I surgical palliation and undergoing
planned Stage II palliative Glenn surgery.

- Individuals up to 18 months of age are eligible if written informed consent can be
obtained from both parents and/or legal guardians, unless one parent is not reasonably
available.

Exclusion Criteria:

- Severe chronic diseases, extensive extra-cardiac syndromic features, or history of
cancer

The following complications of congenital heart disease:

- Any condition requiring urgent, or unplanned procedure within 15 days prior to Stage
II surgical repair.

- Severe pulmonary hypertension (reported in the medical record as >70% systemic
pressure).

- Other clinical concerns as documented by a site investigator that would predict (more
likely to happen than not to happen) a risk of severe complications or very poor
outcome during or after Stage II surgical repair.
We found this trial at
3
sites
Rochester, Minnesota 55905
Principal Investigator: Muhammad Y Qureshi, MBBS
Phone: 507-266-5510
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Rochester, MN
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Joseph W. Rossano, M.D.
Phone: 267-425-6614
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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Oklahoma City, Oklahoma 73104
Principal Investigator: Harold M Burkhart, M.D.
Phone: 405-271-8001
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Oklahoma City, OK
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