Quantifying New Heart Muscle Cells

NCT ID: NCT06587165

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-23
• Study Completion Date: 2027-03-01

Brief Summary

Regenerative therapies could provide new ways of treating heart failure. Unlike many organs in the human body, such as the skin and the GI tract, the ability to regenerate heart muscle decreases after birth, but the precise timing of this decrease and how this decrease is altered in heart disease are uncertain. The investigators will use an innovative approach to quantify cellular heart regeneration in pediatric patients, an appropriate population for determining this decline as well as the potential for reactivating heart muscle regeneration.

The study has now been registered on ClinicalTrials.gov, despite its initiation on July 23, 2015, as registration was not mandated at the original study site, the University of Pittsburgh Medical Center. However, following the transfer of the study to Weill Cornell Medicine, adherence to institutional requirements necessitated its registration on ClinicalTrials.gov.

Conditions

Tetralogy of Fallot With Pulmonary Stenosis; Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

N15-thymidine

Study participants will receive thymidine preparations for pre-defined blocks of time prior to the scheduled routine resection of myocardium.

Group Type: EXPERIMENTAL

N15-thymidine

Intervention Type: OTHER

50mg/kg (oral administration)

Interventions

N15-thymidine

50mg/kg (oral administration)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients at 30 days of age to 1 year of age undergoing scheduled elective cardiac surgery will be eligible for study inclusion.
• The investigators will recruit patients at 30 days of age to 1 year of age with those types of heart disease whose surgical approach has a high probability of myocardial resection.
• Diagnosis of ToF/PS or other types of heart disease that have a high likelihood of requiring surgery that involves routine resection of myocardium that becomes available for research

Exclusion Criteria

• Patients with low chance of having resection of myocardium as part of their surgical care.

• Minimum Eligible Age: 30 Days
• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

California Institute of Technology

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bernhard Kuhn, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rashida Blackwood, BS, MPH

Role: CONTACT

rab4029@med.cornell.edu

646-962-9036

Facility Contacts

Rashida Blackwood

Role: primary

rab4029@med.cornell.edu

6469629036

Other Identifiers

7R01HL151386-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-03027194

Identifier Type: -

Identifier Source: org_study_id