Cardiac Perfusion and Metabolism With [11C] Acetate PET/CT is Associated With Hematopoietic System Activation in Acute Decompensated Heart Failure: An Imaging Sub-study

Phase 1

Withdrawn

• Conditions: Acute Decompensated Heart Failure
• Interventions: Drug: Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT

• Registration Number: NCT03924102
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-07
• Study Start: 2025-12-31
• Primary Completion: 2026-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 β-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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with acute decompensated systolic and diastolic heart	Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Alabama at Birmingham Medical Center; 🇺🇸 Birmingham, Alabama, United States