Identifying Targets of Maladaptive Metabolic Responses in Heart Failure
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03032627|
Recruitment Status : Active, not recruiting
First Posted : January 26, 2017
Last Update Posted : March 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Procedure: Collection of discarded heart tissue||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Identifying Targets of Maladaptive Metabolic Responses in Heart Failure|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Subjects will be recruited by a coordinator through electronic medical record (EMR) searches to identify those undergoing left ventricle assist device (LVAD) implantation and explantation, heart transplant, valve replacement or repair, endomyocardial biopsy during catheterization, and arterial bypass surgery. Prior to the procedure, potential subjects will be informed about the clinical study and if interested, they will be consented.
Procedure: Collection of discarded heart tissue
Discarded heart tissue will be collected from patients undergoing the aforementioned cardiac surgeries.
- Analyses of collected tissues [ Time Frame: Restricted to the time around surgical procedure ]Tissue samples collected during surgery will be analyzed by way of immunoblot and qrtPCR of mRNA for metabolic enzymes on neutralized acid extracts.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032627
|United States, Florida|
|Translational Research Institute for Metabolism and Diabetes|
|Orlando, Florida, United States, 32804|
|Principal Investigator:||Richard E Pratley, MD||Translational Research Institute for Metabolism and Diabetes|