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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03924102
Other study ID # R19-056
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date December 31, 2025
Est. completion date October 31, 2026

Study information

Verified date April 2023
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this sub-study is to use positron emission tomography and computed tomography imaging (PET/CT) with an investigational drug called [11C] acetate to see if inflammation in patients with acute decompensated heart failure (ADHF) can cause changes in blood flow and oxygen use in the heart. This study may help physicians better understand how to treat patients diagnosed with ADHF in the future.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 31, 2026
Est. primary completion date October 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least 18 years of age. - Enrollment in the UAB CMC-ADHF study under the separate UAB approved research protocol (IRB-300000114, PI Rajapreyar) - Negative urine or serum ß-hCG test within 48 hours of [11C] acetate administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing. Exclusion Criteria: - Inability to provide informed consent - Pregnancy - Inability to lie still for the imaging study - Weight exceeding the weight limit of the PET imaging table (500 pounds).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT
A rest and stress imaging study will be conducted on the PET/CT scanner with [11C] Acetate.

Locations

Country Name City State
United States University of Alabama at Birmingham Medical Center Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inflammation in patients with acute decompensated heart failure (ADHF) will be measured with rest-stress [11C] acetate PET/CT to see if the inflammation can cause changes in the blood flow and oxygen use in the heart. 3 years
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