Heart FailureNCT03032627
Identifying Targets of Maladaptive Metabolic Responses in Heart Failure
A study testing Collection of discarded heart tissue in people with Heart Failure, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial summary
The purpose of the research is to help researchers understand changes in metabolism in patients that develop heart failure. Read more about this study
- Who is it for?
- Ages 19 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Collection of discarded heart tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are capable of giving informed consent.
- Age 19-89
- Diagnosis of chronic heart failure
- Any patients scheduled for at least one of the following procedures:
- LVAD implantation or as recipient for cardiac transplantation.
- LVAD placement both as bridge to transplant and as destination therapy.
Show all 10Show fewer
- LVAD explantation
- Valve replacement or repair
- Catheterization and myocardial biopsy for idiopathic cardiomyopathy
- Coronary artery bypass graft (CABG)
Who cannot join
- Life expectancy less than 2 weeks
- Diagnosed with following co-morbidities: cancer, chronic kidney disease (GFR≤30 or serum creatinine >2.1), active infection or treatment with antibiotics or persistent infectious disease (hepatitis, HIV, etc), cirrhosis, active substance abuse and/or alcohol dependence (≥ 14 alcoholic beverages per week).
- Control Myocardial Tissue from Donor Hearts Inclusion Criteria
- Samples collected from non-failing hearts deemed unsuitable for transplantation by TransLife because of either acute recipient issues or post-harvest evidence of pathology or positive but benign serology.
- Normal cardiac function from medical records
- Pathological remodeling and extensive infarction with limited non-pathological regions of myocardium.
- Abnormal or impaired cardiac function from medical records, which are self determinants for rejection as a donor organ.
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
About this study
The purpose of the research is to help researchers understand changes in metabolism in patients that develop heart failure.
- Conditions
- Heart Failure
- Being tested
- Collection of discarded heart tissue
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of discarded heart tissueProcedure or surgery
Discarded heart tissue will be collected from patients undergoing the aforementioned cardiac surgeries.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery | Other | 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. Receives: Procedure: Collection of discarded heart tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyses of collected tissues
Tissue samples collected during surgery will be analyzed by way of immunoblot and qrtPCR of mRNA for metabolic enzymes on neutralized acid extracts.
Measured: Restricted to the time around surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start20 Mar 2017
- Primary completion28 Jun 2019
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Hospital Cardiovascular Institute, Sanford-Burnham Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Richard E Pratley, MD, Principal investigator, Translational Research Institute for Metabolism and Diabetes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032627
- Sponsor's protocol ID
- TRIMDFH 936207
- Status last verified
- Mar 2025
- First submitted
- 17 Jan 2017
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Braunwald E. Heart failure. JACC Heart Fail. 2013 Feb;1(1):1-20. doi: 10.1016/j.jchf.2012.10.002. Epub 2013 Feb 4.
PubMed 24621794Franklyn JA. The molecular mechanisms of thyroid hormone action. Baillieres Clin Endocrinol Metab. 1988 Nov;2(4):891-909. doi: 10.1016/s0950-351x(88)80023-5. No abstract available.
PubMed 2908318Grosjean O, Bluemenstock D. [Pulmonary and renal transplantations in the dog treated by single and later repeated neonatal injections of bone marrow]. C R Seances Soc Biol Fil. 1967 Sep;161(3):733-7. No abstract available. French.
PubMed 4229424Heath DF. Subcellular aspects of the response to trauma. Br Med Bull. 1985 Jul;41(3):240-5. doi: 10.1093/oxfordjournals.bmb.a072057. No abstract available.
PubMed 3896379Ingwall JS, Weiss RG. Is the failing heart energy starved? On using chemical energy to support cardiac function. Circ Res. 2004 Jul 23;95(2):135-45. doi: 10.1161/01.RES.0000137170.41939.d9.
PubMed 15271865Suyama K, Goldstein J, Aebersold R, Kent S. Regarding the size of Rh proteins. Blood. 1991 Jan 15;77(2):411. No abstract available.
PubMed 1898705Blahos J, Mertl L, Gregor O, Kotas J, Reisenauer R. [Stimulating effect of hypercalcaemia on basal gastric secretion (author's transl)]. Cas Lek Cesk. 1974 Aug 2;113(31):944-7. No abstract available. Czech.
PubMed 4410983Bucci E, Mignogna MD. [Diagnosis and prevention of stress in dental patients]. Dent Cadmos. 1986 May 31;54(9):77-8, 80, 82. No abstract available. Italian.
PubMed 3464497Torok B. Microcomputer-based recording system for clinical electrophysiology. Doc Ophthalmol. 1990 Sep;75(2):189-97. doi: 10.1007/BF00146555.
PubMed 2276319Polak J, Kotrc M, Wedellova Z, Jabor A, Malek I, Kautzner J, Kazdova L, Melenovsky V. Lipolytic effects of B-type natriuretic peptide 1-32 in adipose tissue of heart failure patients compared with healthy controls. J Am Coll Cardiol. 2011 Sep 6;58(11):1119-25. doi: 10.1016/j.jacc.2011.05.042.
PubMed 21884948Collins S. A heart-adipose tissue connection in the regulation of energy metabolism. Nat Rev Endocrinol. 2014 Mar;10(3):157-63. doi: 10.1038/nrendo.2013.234. Epub 2013 Dec 3.
PubMed 24296515Kovacova Z, Tharp WG, Liu D, Wei W, Xie H, Collins S, Pratley RE. Adipose tissue natriuretic peptide receptor expression is related to insulin sensitivity in obesity and diabetes. Obesity (Silver Spring). 2016 Apr;24(4):820-8. doi: 10.1002/oby.21418. Epub 2016 Feb 17.
PubMed 26887289
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Targets of Maladaptive Metabolic Responses in Heart Failure
- ClinicalTrials.gov ID
- NCT03032627
- Acronym / sponsor ID
- TRIMDFH 936207
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Collaborators
- Florida Hospital Cardiovascular Institute, Sanford-Burnham Medical Research Institute
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research is to help researchers understand changes in metabolism in patients that develop heart failure.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery | Other | Procedure: Collection of discarded heart tissueSubjects 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. |
Who may qualify
- Ages
- 19 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects are capable of giving informed consent.
- Age 19-89
- Diagnosis of chronic heart failure
- Any patients scheduled for at least one of the following procedures:
Key exclusion criteria (7 listed)
- Life expectancy less than 2 weeks
- Diagnosed with following co-morbidities: cancer, chronic kidney disease (GFR≤30 or serum creatinine >2.1), active infection or treatment with antibiotics or persistent infectious disease (hepatitis, HIV, etc), cirrhosis, active substance abuse and/or alcohol dependence (≥ 14 alcoholic beverages per week).
- Control Myocardial Tissue from Donor Hearts Inclusion Criteria
- Samples collected from non-failing hearts deemed unsuitable for transplantation by TransLife because of either acute recipient issues or post-harvest evidence of pathology or positive but benign serology.
- Normal cardiac function from medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of discarded heart tissueDiscarded heart tissue will be collected from patients undergoing the aforementioned cardiac surgeries. | Procedure or surgery | Cardiac surgery |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: PubMed 24621794Braunwald E. Heart failure. JACC Heart Fail. 2013 Feb;1(1):1-20. doi: 10.1016/j.jchf.2012.10.002. Epub 2013 Feb 4.
- Background: PubMed 2908318Franklyn JA. The molecular mechanisms of thyroid hormone action. Baillieres Clin Endocrinol Metab. 1988 Nov;2(4):891-909. doi: 10.1016/s0950-351x(88)80023-5. No abstract available.
- Background: PubMed 4229424Grosjean O, Bluemenstock D. [Pulmonary and renal transplantations in the dog treated by single and later repeated neonatal injections of bone marrow]. C R Seances Soc Biol Fil. 1967 Sep;161(3):733-7. No abstract available. French.
- Background: PubMed 3896379Heath DF. Subcellular aspects of the response to trauma. Br Med Bull. 1985 Jul;41(3):240-5. doi: 10.1093/oxfordjournals.bmb.a072057. No abstract available.
- Background: PubMed 15271865Ingwall JS, Weiss RG. Is the failing heart energy starved? On using chemical energy to support cardiac function. Circ Res. 2004 Jul 23;95(2):135-45. doi: 10.1161/01.RES.0000137170.41939.d9.
- Background: PubMed 1898705Suyama K, Goldstein J, Aebersold R, Kent S. Regarding the size of Rh proteins. Blood. 1991 Jan 15;77(2):411. No abstract available.
- Background: PubMed 4410983Blahos J, Mertl L, Gregor O, Kotas J, Reisenauer R. [Stimulating effect of hypercalcaemia on basal gastric secretion (author's transl)]. Cas Lek Cesk. 1974 Aug 2;113(31):944-7. No abstract available. Czech.
- Background: PubMed 3464497Bucci E, Mignogna MD. [Diagnosis and prevention of stress in dental patients]. Dent Cadmos. 1986 May 31;54(9):77-8, 80, 82. No abstract available. Italian.
- Background: PubMed 2276319Torok B. Microcomputer-based recording system for clinical electrophysiology. Doc Ophthalmol. 1990 Sep;75(2):189-97. doi: 10.1007/BF00146555.
- Background: PubMed 21884948Polak J, Kotrc M, Wedellova Z, Jabor A, Malek I, Kautzner J, Kazdova L, Melenovsky V. Lipolytic effects of B-type natriuretic peptide 1-32 in adipose tissue of heart failure patients compared with healthy controls. J Am Coll Cardiol. 2011 Sep 6;58(11):1119-25. doi: 10.1016/j.jacc.2011.05.042.
- Background: PubMed 24296515Collins S. A heart-adipose tissue connection in the regulation of energy metabolism. Nat Rev Endocrinol. 2014 Mar;10(3):157-63. doi: 10.1038/nrendo.2013.234. Epub 2013 Dec 3.
- Background: PubMed 26887289Kovacova Z, Tharp WG, Liu D, Wei W, Xie H, Collins S, Pratley RE. Adipose tissue natriuretic peptide receptor expression is related to insulin sensitivity in obesity and diabetes. Obesity (Silver Spring). 2016 Apr;24(4):820-8. doi: 10.1002/oby.21418. Epub 2016 Feb 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard E Pratley, MD principal investigator
Translational Research Institute for Metabolism and Diabetes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of discarded heart tissue in people with Heart Failure, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyses of collected tissues (time frame: Restricted to the time around surgical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03032627, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.