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

NCT03924102 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: R19-056
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

patients with acute decompensated systolic and diastolic heart

EXPERIMENTAL

Drug: Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT

Interventions

Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT DRUG

A rest and stress imaging study will be conducted on the PET/CT scanner with \[11C\] Acetate.

patients with acute decompensated systolic and diastolic heart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Interventions

Metabolism

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Molecular Imaging and Therapeutics

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 23, 2019
• Study Start: December 31, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

US (1)