Identifying Targets of Maladaptive Metabolic Responses in Heart Failure

Heart Failure Clinical Trial

Official title:

Identifying Targets of Maladaptive Metabolic Responses in Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03032627
• Other study ID #: TRIMDFH 936207
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 20, 2017
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: AdventHealth Translational Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the research is to help researchers understand changes in metabolism in patients that develop heart failure.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: December 2023
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 89 Years

Eligibility

Inclusion Criteria:

1. Subjects are capable of giving informed consent.

2. Age 19-89

3. Diagnosis of chronic heart failure

4. Any patients scheduled for at least one of the following procedures:

1. LVAD implantation or as recipient for cardiac transplantation.

2. LVAD placement both as bridge to transplant and as destination therapy.

3. LVAD explantation

4. Valve replacement or repair

5. Catheterization and myocardial biopsy for idiopathic cardiomyopathy

6. Coronary artery bypass graft (CABG)

Exclusion Criteria:

1. Life expectancy less than 2 weeks

2. 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

1. 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.

2. Normal cardiac function from medical records

Exclusion Criteria:

1. Pathological remodeling and extensive infarction with limited non-pathological regions of myocardium.

2. Abnormal or impaired cardiac function from medical records, which are self determinants for rejection as a donor organ.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Collection of discarded heart tissue
Discarded heart tissue will be collected from patients undergoing the aforementioned cardiac surgeries.

Locations

Country	Name	City	State
United States	Translational Research Institute for Metabolism and Diabetes	Orlando	Florida

Sponsors (3)

Lead Sponsor	Collaborator
AdventHealth Translational Research Institute	Florida Hospital Cardiovascular Institute, Sanford-Burnham Medical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (12)

Blahos 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. — View Citation

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. — View Citation

Bucci 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. — View Citation

Collins 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. — View Citation

Franklyn 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. — View Citation

Grosjean 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. — View Citation

Heath 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. — View Citation

Ingwall 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. — View Citation

Kovacova 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. — View Citation

Polak 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. — View Citation

Suyama K, Goldstein J, Aebersold R, Kent S. Regarding the size of Rh proteins. Blood. 1991 Jan 15;77(2):411. No abstract available. — View Citation

Torok B. Microcomputer-based recording system for clinical electrophysiology. Doc Ophthalmol. 1990 Sep;75(2):189-97. doi: 10.1007/BF00146555. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Restricted to the time around surgical procedure