Trial record 4 of 47 for:    "Hypoplastic left heart syndrome"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01708863
Recruitment Status : Unknown
Verified March 2016 by Timothy J. Nelson, Mayo Clinic.
Recruitment status was:  Recruiting
First Posted : October 17, 2012
Last Update Posted : March 15, 2016
University of Oklahoma
Information provided by (Responsible Party):
Timothy J. Nelson, Mayo Clinic

Brief Summary:

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 or disease
Hypoplastic Left Heart Syndrome

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2012
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Children with Hypoplastic Left Heart Syndrome (HLHS)
HLHS patients requiring Stage II Glenn surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Months   (Child)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01708863

Contact: Karen S Miller 507-266-5510
Contact: Karen M Cavanaugh 507-538-8425

United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55901
Contact: Karen S Miller    507-266-5510   
Contact: Karen M Cavanaugh    507-538-8425   
Principal Investigator: Muhammad Y Qureshi, MBBS         
United States, Oklahoma
Oklahoma University Children's Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Stephanie Mitchell    405-271-2128   
Contact: Nicholas Farley    405-271-4411 ext 44403   
Principal Investigator: Harold M Burkhart, M.D.         
Sponsors and Collaborators
Timothy J. Nelson
University of Oklahoma
Study Director: Timothy J Nelson, MD, PhD Mayo Clinic
Principal Investigator: Muhammad Y Qureshi, MBBS Mayo Clinic

Responsible Party: Timothy J. Nelson, Program Director, Mayo Clinic Identifier: NCT01708863     History of Changes
Other Study ID Numbers: 12-002887
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016

Keywords provided by Timothy J. Nelson, 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
Pathologic Processes
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities