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We plan to study the concept of "energy starvation" in heart failure by evaluation of patients with nonischemic dilated cardiomyopathy (NIDCM) (heart failure with reduced heart pump function due to causes other than heart attack). We will use a combination of positron emission tomography and magnetic resonance imaging to study metabolism, anatomy, function, blood flow and efficiency, before and after 6 months' treatment with the drug spironolactone which blocks the deleterious effects of the hormone aldosterone on the myocardium (heart muscle).
Preliminary results showed reduced subendocardial myocardial perfusion reserve in NIDCM compared to normal subjects, and that the degree of impaired perfusion reserve was related to the oxidative metabolic rate as measured by positron emission tomography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Results with spironolactone | Experimental | patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by 11C acetate positron emission tomography and magnetic resonance imaging using vasodilator and gadolinium to judge myocardial blood flow, before and after 6 months' treatment with spironolactone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spironolactone | Drug | spironolactone 50 mg daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Work-metabolic Index (WMI) at Baseline | WMI=[left ventricular stroke work/decay rate of 11C-acetate] | baseline |
| Left Ventricular Work-metabolic Index (WMI) at 6 Months | WMI=[left ventricular stroke work/decay rate of 11C-acetate] | 6 months |
| Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at Baseline | MPRI =calculated myocardial perfusion reserve index based on Gadolinium accretion into myocardium. MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope. | baseline |
| Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months | MPRI =calculated myocardial perfusion reserve index based on Gadolinium accretion into myocardium. MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope. | 6 months |
| Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging | T1=left ventricular relaxation rate on magnetic resonance imaging, which is correlated with interstitial fibrosis. | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk Test (6MWT) at Baseline | 6MWT assesses distance walked over 6 minutes | baseline |
| 6 Minute Walk Test (6MWT) at 6 Months | 6MWT assesses distance walked over 6 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marvin W Kronenberg, MD | Vanderbilt University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt Heart and Vascular Institute | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33403831 | Derived | Lawson MA, Hansen DE, Gupta DK, Bell SP, Adkisson DW, Mallugari RR, Sawyer DB, Ooi H, Kronenberg MW. Modification of ventriculo-arterial coupling by spironolactone in nonischemic dilated cardiomyopathy. ESC Heart Fail. 2021 Apr;8(2):1156-1166. doi: 10.1002/ehf2.13161. Epub 2021 Jan 5. | |
| 30286821 | Derived | Bradham WS, Bell SP, Huang S, Harrell FE Jr, Adkisson DW, Lawson MA, Sawyer DB, Ooi H, Kronenberg MW. Timing of Left Ventricular Remodeling in Nonischemic Dilated Cardiomyopathy. Am J Med Sci. 2018 Sep;356(3):262-267. doi: 10.1016/j.amjms.2018.06.003. Epub 2018 Jun 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Results With Spironolactone | patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by 11C acetate positron emission tomography and magnetic resonance imaging using vasodilator and gadolinium to judge myocardial blood flow, before and after 6 months' treatment with spironolactone. spironolactone: spironolactone 50 mg daily for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
one patient excluded prior to drug administration due to normal LV function.
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| ID | Title | Description |
|---|---|---|
| BG000 | Results With Spironolactone | patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by 11C acetate positron emission tomography and magnetic resonance imaging using vasodilator and gadolinium to judge myocardial blood flow, before and after 6 months' treatment with spironolactone. spironolactone: spironolactone 50 mg daily for 6 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Left Ventricular Work-metabolic Index (WMI) at Baseline | WMI=[left ventricular stroke work/decay rate of 11C-acetate] | 12 patients completed study | Posted | Median | Inter-Quartile Range | (x10^6), mL x mm Hg/m^2 | baseline |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Results With Spironolactone | patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by 11C acetate positron emission tomography and magnetic resonance imaging using vasodilator and gadolinium to judge myocardial blood flow, before and after 6 months' treatment with spironolactone. spironolactone: spironolactone 50 mg daily for 6 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | shortness of breath during test |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marvin W. Kronenberg,M.D. | Vanderbilt University School of Medicine | 615 936-7437 | marvin.w.kronenberg@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 22, 2011 | May 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| 6 months |
| Minnesota Living With Heart Failure Questionnaire,at Baseline | The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each question is scored from 0 (none or not applicable) to 5 (very much). Total scores range from 0-105. Low scores indicate less adverse impact, while higher scores reflect more adverse impact of heart failure. | baseline |
| Minnesota Living With Heart Failure Questionnaire.at 6 Months | The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each question is scored from 0 (none or not applicable) to 5 (very much). Total scores range from 0-105. Low scores indicate less adverse impact, while higher scores reflect more adverse impact of heart failure. | 6 months |
| 25515841 | Derived | Lawson MA, Bell SP, Adkisson DW, Wang L, Ooi H, Sawyer DB, Kronenberg MW. High reproducibility of adenosine stress cardiac MR myocardial perfusion imaging in patients with non-ischaemic dilated cardiomyopathy. BMJ Open. 2014 Dec 16;4(12):e005984. doi: 10.1136/bmjopen-2014-005984. |
| 25164945 | Derived | Bell SP, Adkisson DW, Lawson MA, Wang L, Ooi H, Sawyer DB, Kronenberg MW. Antifailure therapy including spironolactone improves left ventricular energy supply-demand relations in nonischemic dilated cardiomyopathy. J Am Heart Assoc. 2014 Aug 27;3(4):e000883. doi: 10.1161/JAHA.114.000883. |
| 24331202 | Derived | Bell SP, Adkisson DW, Ooi H, Sawyer DB, Lawson MA, Kronenberg MW. Impairment of subendocardial perfusion reserve and oxidative metabolism in nonischemic dilated cardiomyopathy. J Card Fail. 2013 Dec;19(12):802-10. doi: 10.1016/j.cardfail.2013.10.010. Epub 2013 Oct 29. |
| Physician Decision |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Left Ventricular Work-metabolic Index (WMI) at 6 Months | WMI=[left ventricular stroke work/decay rate of 11C-acetate] | 12 patients completed study | Posted | Median | Inter-Quartile Range | (x10^6), mL x mm Hg/m^2 | 6 months |
|
|
|
| Primary | Myocardial Perfusion Reserve Index (MPRI) by Magnetic Resonance Imaging at Baseline | MPRI =calculated myocardial perfusion reserve index based on Gadolinium accretion into myocardium. MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope. | Posted | Mean | Inter-Quartile Range | MPRI | baseline |
|
|
|
| Primary | Myocardial Perfusion Index Reserve (MPRI) by Magnetic Resonance Imaging at 6 Months | MPRI =calculated myocardial perfusion reserve index based on Gadolinium accretion into myocardium. MPRI was calculated as the ratio of stress/rest relative perfusion upslope, corrected for LV cavity upslope. | Posted | Mean | Inter-Quartile Range | MPRI | 6 months |
|
|
|
| Primary | Change in Myocardial Fibrosis (T1 Time) by Magnetic Resonance Imaging | T1=left ventricular relaxation rate on magnetic resonance imaging, which is correlated with interstitial fibrosis. | Posted | Mean | Standard Deviation | msec | baseline and 6 months |
|
|
|
| Secondary | 6 Minute Walk Test (6MWT) at Baseline | 6MWT assesses distance walked over 6 minutes | Posted | Median | Inter-Quartile Range | meters | baseline |
|
|
|
| Secondary | 6 Minute Walk Test (6MWT) at 6 Months | 6MWT assesses distance walked over 6 minutes | Posted | Median | Inter-Quartile Range | meters | 6 months |
|
|
|
| Secondary | Minnesota Living With Heart Failure Questionnaire,at Baseline | The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each question is scored from 0 (none or not applicable) to 5 (very much). Total scores range from 0-105. Low scores indicate less adverse impact, while higher scores reflect more adverse impact of heart failure. | Posted | Median | Inter-Quartile Range | score on a scale | baseline |
|
|
|
| Secondary | Minnesota Living With Heart Failure Questionnaire.at 6 Months | The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each question is scored from 0 (none or not applicable) to 5 (very much). Total scores range from 0-105. Low scores indicate less adverse impact, while higher scores reflect more adverse impact of heart failure. | Posted | Median | Inter-Quartile Range | score on a scale | 6 months |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 2 |
| 16 |
|
| pacemaker insertion | Cardiac disorders | Systematic Assessment | pacemaker insertion by personal physician |
|
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| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |