Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF (HFpEF-PRoF)
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ClinicalTrials.gov Identifier: NCT02589977 |
Recruitment Status :
Completed
First Posted : October 28, 2015
Results First Posted : February 2, 2021
Last Update Posted : February 2, 2021
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Tracking Information | ||||
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First Submitted Date ICMJE | August 24, 2015 | |||
First Posted Date ICMJE | October 28, 2015 | |||
Results First Submitted Date ICMJE | December 23, 2020 | |||
Results First Posted Date ICMJE | February 2, 2021 | |||
Last Update Posted Date | February 2, 2021 | |||
Study Start Date ICMJE | November 2015 | |||
Actual Primary Completion Date | January 21, 2020 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Coronary Flow Reserve [ Time Frame: Baseline study visit ] Rest and regadenoson stress coronary flow reserve by ammonia PET. Coronary flow calculated at rest and again at stress with coronary flow reserve calculated as the ratio of stress to rest coronary flow.
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Original Primary Outcome Measures ICMJE |
Enumerate participants meeting criteria for "myocardial energy starvation" among patients with HFpEF vs. hypertensive and normal subjects, using myocardial blood flow on CMR and PET, oxidative metabolism (11C-acetate) and interstitial fibrosis on CMR. [ Time Frame: 3 years ] rest and regadenoson stress myocardial blood flow in each study group, using CMR and PET, oxidative metabolism using 11C-acetate and interstitial fibrosis on CMR. The criterion for defining "energy starvation" is the combination of abnormal myocardial blood flow on CMR or PET, abnormal values for fibrosis on CMR and abnormally low oxidative metabolic rate.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF | |||
Official Title ICMJE | Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF | |||
Brief Summary | Unlike heart failure with reduced ejection fraction (HFrEF) where several medicines and devices have been demonstrated to reduce mortality, no such therapies have been identified in HFpEF. This may be in part due to incomplete understanding of the underlying mechanisms of HFpEF. Recently, impaired myocardial blood flow, reduced myocardial energy utilization, and increased myocardial fibrosis have been postulated to play important pathophysiologic roles in HFpEF. The investigators and others have demonstrated that HFrEF may be associated with altered myocardial energy utilization and "energy starvation." However, there are limited data regarding "energy starvation" in HFpEF and the relationships between myocardial blood flow, energy utilization, and fibrosis in HFpEF are largely unknown. Therefore, the purposes of this study are to use non-invasive cardiac imaging techniques to describe cardiac structure, function, blood flow, energetics, and fibrosis, and the relationships between these in order to better understand underlying mechanisms in HFpEF. |
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Detailed Description | The investigators hypothesize that HFpEF is associated with reductions in myocardial blood flow and energy utilization and increased myocardial fibrosis as compared to age and gender matched hypertensive and healthy controls. The investigators will test their hypotheses by comparing measurements of myocardial blood flow, energy utilization, and fibrosis between three subject groups (HFpEF vs hypertension vs healthy). Myocardial blood flow will be quantitated from nitrogen (N)13-Ammonia positron emission tomography (PET) and gadolinium enhanced cardiac magnetic resonance (CMR) imaging, both at rest and stress following coronary vasodilation with regadenoson. Myocardial energy utilization will be quantified with 11C-acetate PET imaging and myocardial fibrosis will be assessed with gadolinium enhanced CMR and alterations in myocardial T1. Echocardiography will be utilized to quantify cardiac diastolic function. It is anticipated that the results of this proposed study will provide a foundation that will inform future studies aimed at identifying novel preventive or therapeutic agents in HFpEF. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Factorial Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Drug: regadenoson
evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants
Other Names:
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
55 | |||
Original Estimated Enrollment ICMJE |
60 | |||
Actual Study Completion Date ICMJE | January 21, 2020 | |||
Actual Primary Completion Date | January 21, 2020 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | ALL Inclusion Criteria:
Exclusion Criteria:
HEALTHY Inclusion criteria:
Exclusion criteria:
HYPERTENSIVE Inclusion criteria:
Exclusion criteria:
HFpEF Inclusion criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 50 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02589977 | |||
Other Study ID Numbers ICMJE | 141686 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Marvin W. Kronenberg, M.D., Vanderbilt University Medical Center | |||
Study Sponsor ICMJE | Marvin W. Kronenberg, M.D. | |||
Collaborators ICMJE | Astellas Pharma US, Inc. | |||
Investigators ICMJE |
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PRS Account | Vanderbilt University Medical Center | |||
Verification Date | February 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |