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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Timothy J. Nelson, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01708863
First received: October 15, 2012
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  Purpose

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 10-20 patients.


Condition
Hypoplastic Left Heart Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A PROSPECTIVE STUDY OF PATIENTS WITH HYPOPLASTIC LEFT HEART SYNDROME FOLLOWING STAGE II SURGICAL PALLIATION

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children with Hypoplastic Left Heart Syndrome (HLHS)
HLHS patients requiring Stage II Glenn surgery

  Eligibility

Ages Eligible for Study:   up to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children with HLHS up to 18 months of age requiring a planned Stage II bi-directional Glenn surgery

Criteria

Inclusion Criteria:

  • Up to 18 months of age
  • Undergoing planned Stage II Glenn palliative surgery
  • History of successful modified Norwood procedure utilizing a RV-PA shunt
  • 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, extra-cardiac syndromes, or cancer

  • The following conditions within 15 days prior to the date of the Stage II Glenn surgery:

    • Cardiogenic shock
    • Pulmonary hypertension requiring chronic medical therapy (e.g. supplemental oxygen, vasodilator)
    • Arrhythmia that required medication for control
  • Any documented infection requiring treatment with IV antibiotics, and/or current infection being treated with antibiotics

  • The following complications of their congenital heart disease:

    • Any condition requiring urgent, or unplanned procedure 15 days prior to Stage II Glenn surgery
  • Tricuspid repair and/or aortic arch repair at the time of Stage II Glenn surgery

  • Length of hospitalization of more than 60 days for Stage I Norwood procedure

    • Chylothorax requiring dietary modifications
    • Seizure or neurological injury
    • Moderate to severe tricuspid regurgitation prior to Stage II Glenn surgery
    • History of extracorporeal membrane oxygenator (ECMO) support
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708863

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55901
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Timothy J. Nelson, Timothy J. Nelson, M.D., Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01708863     History of Changes
Other Study ID Numbers: 12-002887
Study First Received: October 15, 2012
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Hypoplastic Left Heart Syndrome
Stage II palliative surgery
Glenn procedure
 Congenital heart defect
Congenital heart disease
Underdeveloped left ventricle

Additional relevant MeSH terms:
Hypoplastic Left Heart Syndrome
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 16, 2013