Quantifying New Heart Muscle Cells

NCT06587165 | Recruiting

• 2 other identifiers: 24-030271947R01HL151386-05
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of labeled cardiomyocytes for each patient

  The investigators will use, multi-isotope imaging mass spectrometry (MIMS) to quantify the generation of new cardiomyocytes by examining myocardial samples that are routinely resected and discarded during cardiac surgery. Investigators will then calculate the percentage of labeled, i.e. newly generated, cardiomyocytes, for each patient. The data from the analysis of myocardial samples will be the test results. Investigators will first compare these results with technical controls.

  6 months

Study Arms (1)

N15-thymidine

EXPERIMENTAL

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

Other: N15-thymidine

Interventions

N15-thymidine OTHER

50mg/kg (oral administration)

N15-thymidine

Eligibility Criteria

• Age: 30 Days - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• California Institute of Technology: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bernhard Kuhn, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rashida Blackwood, BS, MPH

CONTACT

646-962-9036; rab4029@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: September 19, 2024
• Study Start: July 23, 2015
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)