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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03924102

Recruitment Status Not yet recruiting

First Posted April 23, 2019

Last update posted March 12, 2021

Study Description

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.

  • Condition or Disease:Acute Decompensated Heart Failure
  • Intervention/Treatment: Drug: Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • Official Title: Cardiac Perfusion and Metabolism With [11C] Acetate PET/CT is Associated With Hematopoietic System Activation in Acute Decompensated Heart Failure: An Imaging Sub-study
  • Estimated Study Start Date: December 2021
  • Estimated Primary Completion Date: October 2022
  • Estimated Study Completion Date: October 2022
Arms and interventions
Arm Intervention/treatment
Experimental: patients with acute decompensated systolic and diastolic heart
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.
Outcome Measures
  • Primary Outcome Measures: 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. [ Time Frame: 3 years ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

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).

Contacts and Locations
Contacts

Contact: Pradeep Bhambhvani, MD 205-934-1388 pbhambhvani@uabmc.edu

Contact: April Riddle, BSRT 205-934-6504 ariddle@uabmc.edu

Locations

United States, Alabama
University of Alabama at Birmingham Medical Center
Birmingham

Sponsors and Collaborators

University of Alabama at Birmingham

More Information
  • Responsible Party: University of Alabama at Birmingham
  • ClinicalTrials.gov Identifier: NCT03924102 History of Changes
  • Other Study ID Numbers: R19-056
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: March 12, 2021
  • Last Verified: March 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Heart Failure