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Heart FailureNCT02697669

The Role of Nuclear Imaging in Heart Failure

An observational study of Heart Failure, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Heart Failure
What is being tested?
18F-FDG PET
How many people
200 participants
Where
1 siteTaiwan
Study dates
Aug 2012to Dec 2018
Phase
Observational
Are there results?
None posted in the registry

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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Had a clinical diagnosis of heart failure and left ventricular systolic function (LVEF≤50%) or diastolic dysfunction who, or (2) Clinical diagnosis of metabolic diseases (such as metabolic syndrome, obesity, diabetes, hyperlipidemia, micro vascular diseases etc.), heart failure and high-risk groups.

Who may be able to join

  • Had a clinical diagnosis of heart failure and left ventricular systolic function (LVEF≤50%) or diastolic dysfunction who,
  • Clinical diagnosis of metabolic diseases (such as metabolic syndrome, obesity, diabetes, hyperlipidemia, microvascular diseases etc.), heart failure and high-risk groups.

Who cannot join

  • 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.
  • pregnant or lactating women.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • Far Eastern Memorial Hospital

    New Taipei City, 220

    Yen-Wen Wu, MD, PhD, 886-2-8966-7000 ext. 1090, wuyw0502@gmail.com

    Yen-Wen Wu, MD, PhD

    Recruiting

Other trials in Taiwan

About this study

Official title: The Role of Nuclear Imaging in Heart Failure: Correlation With Cardiac Function and Metabolism, Biomarkers and Clinical Prognosis

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.

Read the 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.

Conditions
Heart Failure
Being tested
18F-FDG PET
Keywords
Heart failure, myocardial perfusion, single-photon emission tomography
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-FDG PETOther

    Also called Imaging

    Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LV function

    LVEF

    Measured: 12mo

Secondary outcomes (1)
  1. MACE

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

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2016 (estimated)
  2. Study startAug 2012
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02697669
Sponsor's protocol ID
101037_F
Status last verified
Feb 2018
First submitted
27 Feb 2016
Last updated
20 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Far Eastern Memorial Hospital at 1 site in Taiwan.

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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Feb 2018. 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 Taiwan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yen-Wen Wu, MD, PhD (886-2-8966-7000 ext. 1090, wuyw0502@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LV function (time frame: 12mo). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Feb 2018.

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