The Role of Nuclear Imaging in Heart Failure

Sponsor
Far Eastern Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02697669
Collaborator
(none)
200
1
76
2.6

Study Details

Study Description

Brief Summary

Heart failure is a clinical syndrome of exercise intolerance and/or congestion. The potential roles of myocardial perfusion and metabolic abnormalities in subjects with cardiovascular risks, metabolic disease and heart failure assessed by nuclear dynamic imaging warrant further investigations. The study investigators propose that microvascular dysfunction and abnormal metabolic substrate shift precedes and triggers the onset of diastolic dysfunctions. The aims are (1) to develop and validate the noninvasive measurement of absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) by using dynamic imaging with a CZT camera, (2) to assess myocardial glucose metabolism by using 18F-FDG dynamic PET, and MBF, MFR and LV systolic and diastolic function by dynamic SPECT comprehensively in subjects at cardiovascular risks and metabolic disease, HFrEF and HFpEF, (3) to correlate with peripheral serum markers and blood mononuclear cells subsets with myocardial perfusion and metabolic abnormalities, and (4) to test the hypothesis of these imaging and blood markers in diagnosis and prognostic implications. The study investigators also assess myocardial metabolic utilization in healthy and mice model of different metabolic disorders (obesity, diabetes mellitus and hypertension) by using 18F-FDG dynamic micro PET/CT, as an in-vivo measures which could be used to better understanding the disease mechanism and evaluating therapeutic strategies.

Condition or Disease Intervention/Treatment Phase
  • Other: 18F-FDG PET

Detailed Description

Heart failure (HF) is a clinical syndrome of exercise intolerance and/or congestion. The management of heart failure with reduced ejection fraction (HFrEF) has improved over the last decades. In contrast, little progress has been made in identifying evidence-based, effective treatments for heart failure with preserved ejection fraction (HFpEF, LVEF >50%). Treatments proven effective in HFrEF have failed to show significant benefit in patients with HFpEF. Potential contributors include an incomplete understanding of pathophysiology and poor matching of therapeutic mechanisms. The challenges of the use of diagnostic criteria, prognostic evaluation and treatment highlight the need for more research in this field.

This portion of HFpEF consists predominantly older age and high prevalence of co-morbidity such as overweight/obesity, diabetes mellitus, hyperlipidemia, metabolic syndrome and hypertension. The systemic pro-inflammatory state may induce coronary endothelial inflammation, microvasular dysfunction, myocardial substrate shift, myocardial and interstitial fibrosis that contribute to high diastolic left ventricular stiffness and HF development. Myocardial metabolic and perfusion imaging is a vital tool for understanding the physiologic consequences of HF. Absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) provide incremental diagnostic and prognostic information over relative perfusion alone. Recent development of dedicated cardiac SPECT cameras with better sensitivity and temporal resolution make dynamic SPECT imaging more practical. Quantitative 18F-FDG PET could be used as a means to measure myocardial metabolic changes. The study investigators propose that microvasular dysfunction and abnormal metabolic substrate shift precedes and triggers the onset of diastolic dysfunctions. The potential roles of myocardial perfusion and metabolic abnormalities in subjects with cardiovascular risks, metabolic disease and HFpEF assessed by nuclear dynamic imaging warrant further investigations.

The present project aims (1) to develop and validate the noninvasive measurement of absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) by using dynamic imaging with a CZT camera, (2) to assess myocardial glucose metabolism by using 18F-FDG dynamic PET, and MBF, MFR and LV systolic and diastolic function by dynamic SPECT comprehensively in participants at cardiovascular risks and metabolic disease, HFrEF and HFpEF, (3) to correlate with peripheral serum markers and blood mononuclear cells subsets with myocardial perfusion and metabolic abnormalities, and (4) to test the hypothesis of these imaging and blood markers in diagnosis and prognostic implications. The study investigators also assess myocardial metabolic utilization in healthy and mice model of different metabolic disorders (obesity, diabetes mellitus and hypertension) by using 18F-FDG dynamic micro PET/CT, as an in-vivo measures which could be used to better understanding the disease mechanism and evaluating therapeutic strategies.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
The Role of Nuclear Imaging in Heart Failure: Correlation With Cardiac Function and Metabolism, Biomarkers and Clinical Prognosis
Study Start Date :
Aug 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Outcome Measures

Primary Outcome Measures

  1. LV function [12mo]

    LVEF

Secondary Outcome Measures

  1. MACE [5 years]

    acute myocardial infarction, revasculiarization, ICD, heart transplantation, other cardiac surgery, hospitalization for heart failure, cardiac death, non-cardiac death

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Had a clinical diagnosis of heart failure and left ventricular systolic function (LVEF≤50%) or diastolic dysfunction who,

  2. Clinical diagnosis of metabolic diseases (such as metabolic syndrome, obesity, diabetes, hyperlipidemia, microvascular diseases etc.), heart failure and high-risk groups.

Exclusion Criteria:
  1. Important systemic disease (except for heart disease) such as cirrhosis, end-stage renal disease or active malignancy were estimated life expectancy of less than three months.

  2. pregnant or lactating women.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Far Eastern Memorial Hospital New Taipei City Taiwan 220

Sponsors and Collaborators

  • Far Eastern Memorial Hospital

Investigators

  • Principal Investigator: Yen-Wen Wu, MD, PhD, Far Eastern Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yen-Wen Wu, Chief of Cardiology Division of Cardiovascular Medical Center, Far Eastern Memorial Hospital, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT02697669
Other Study ID Numbers:
  • 101037_F
First Posted:
Mar 3, 2016
Last Update Posted:
Feb 20, 2018
Last Verified:
Feb 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yen-Wen Wu, Chief of Cardiology Division of Cardiovascular Medical Center, Far Eastern Memorial Hospital, Far Eastern Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 20, 2018