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Heart Failure, DiastolicPhase 4HFpEF-PRoFNCT02589977

Myocardial Perfusion, Oxidative Metabolism, and Fibrosis in HFpEF

A Phase 4 study testing regadenoson in people with Heart Failure, Diastolic and Diastolic Heart Failure, run by Marvin W. Kronenberg, M.D. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
What is being tested?
regadenoson
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
Nov 2015to 21 Jan 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • estimated glomerular filtration rate (eGFR) > 60 ml/min
  • preserved left ventricular ejection fraction (>= 50%) on echocardiography
  • normal cardiac structure and function on echocardiography
  • BP < 140/90
  • history of BP >140/90
  • 1 or more antihypertensive medications
Show all 13Show fewer
  • LV ejection fraction (LVEF) at least 50%
  • current BP < 160/90
  • physician-confirmed diagnosis of HF
  • symptomatic HF
  • LVEF at least 50%
  • elevated LV filling pressure by catheterization, echocardiographic criteria or B-type-natriuretic peptide > 100
  • current BP < 160/90

Who cannot join

  • coronary artery disease
  • diabetes mellitus
  • contraindications to cardiac magnetic resonance imaging (CMR)
  • weight >350 lbs
  • inability to lie flat for imaging
  • anemia
Show all 19Show fewer
  • contraindications to regadenoson or aminophylline
  • HEALTHY
  • known cardiovascular disease, cardiac risk factors or use of cardiac medications
  • HYPERTENSIVE
  • known cardiovascular disease or risk factors aside from hypertension or use of cardiac medications
  • HFpEF
  • prior history of LVEF below 50%
  • acute decompensated HF
  • moderate or greater valvular disease
  • significant cardiac arrhythmias
  • pericardial disease
  • congenital heart disease
  • primary pulmonary hypertension

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

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.

Read the 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.

Being tested
regadenoson
Keywords
magnetic resonance imaging, positron-emission tomography, echocardiography, myocardial blood flow, energy metabolism
Medical subject headings
Heart Failure, Diastolic, Hypertension

What participants receive

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

  • regadenosonDrug

    Also called positron emission tomography, echocardiography, cardiac magnetic resonance imaging

    evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants

Study groups in NCT02589977
Study groupRoleWhat they receive
normal participantsOtherNo cardiovascular abnormalities or diabetes. Estimated glomerular filtration rate (eGFR) >60. Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.
Receives: Drug: regadenoson
hypertensive participantsOtherNo history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60. Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.
Receives: Drug: regadenoson
HFpEF patientsOtherNo history of coronary artery disease or diabetes. Estimated glomerular filtration rate (eGFR) >60. Studies: Echocardiography for left ventricular function and LV diastolic performance; cardiac magnetic resonance (CMR) imaging using gadolinium for LV fibrosis and regadenoson for myocardial blood flow (MBF); positron-emission tomography (PET) using regadenoson for MBF and 11C-acetate for oxidative metabolism.
Receives: Drug: regadenoson

What is being measured

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

  1. Coronary Flow Reserve

    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.

    Measured: Baseline study visit

Secondary outcomes (4)

  1. Myocardial Perfusion Reserve by CMR in Each Study Group.

    Myocardial perfusion reserve by CMR.

    Measured: Baseline study visit.

  2. Extracellular Volume (ECV) by CMR in Each Study Group

    Extracellular volume (ECV) by CMR.

    Measured: Baseline study visit

  3. Oxidative Metabolism (Kmono/Rate Pressure Product) by PET in Each Study Group.

    Oxidative metabolism (Kmono/rate pressure product) by PET.

    Measured: Baseline study visit

  4. E/e' by Echo in Each Study Group.

    E/e' by echo. E is the transmitral peak velocity in early diastole. e' is the early diastolic tissue Doppler velocity average between the septal and lateral mitral annulus. E/e' is the ratio of these two values.

    Measured: Baseline study visit

Timeline

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

  1. First posted28 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completion21 Jan 2020
  4. Study completion21 Jan 2020

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02589977
Sponsor's protocol ID
141686
Acronym
HFpEF-PRoF
Status last verified
Feb 2021
First submitted
24 Aug 2015
Last updated
2 Feb 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 24331202

  • Gupta DK, Shah AM, Castagno D, Takeuchi M, Loehr LR, Fox ER, Butler KR, Mosley TH, Kitzman DW, Solomon SD. Heart failure with preserved ejection fraction in African Americans: The ARIC (Atherosclerosis Risk In Communities) study. JACC Heart Fail. 2013 Apr;1(2):156-63. doi: 10.1016/j.jchf.2013.01.003.

    PubMed 23671819

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing regadenoson in people with Heart Failure, Diastolic and Diastolic Heart Failure, run by Marvin W. Kronenberg, M.D. at 1 site in United States.

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 13 inclusion and 19 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: finished, as of the sponsor's last update on 2 Feb 2021. 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 United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coronary Flow Reserve (time frame: Baseline study visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02589977, which also lists 2 linked publications.

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 2 Feb 2021.

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