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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Timothy J. Nelson, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01708863
First received: October 15, 2012
Last updated: February 4, 2014
Last verified: February 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708863

Contacts
Contact: Karen P Krucker, RN 507-255-4774 krucker.karen@mayo.edu
Contact: Julia M Thebiay 507-538-8425 thebiay.julia@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Karen P Krucker, RN    507-255-4774    krucker.karen@mayo.edu   
Principal Investigator: Timothy J Nelson, MD PhD         
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: February 4, 2014
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 August 28, 2014