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Effect of Chronic Inflammation on Myocardial Perfusion and Function

Study Purpose

Background: Heart failure (HF) is a public health burden. Studies have shown a link between inflammation, myocardial dysfunction, and HF. Researchers want to use psoriasis as a disease model of chronic inflammation to further study the link between inflammation and myocardial dysfunction. Objective: To learn if chronic inflammation affects the heart and if taking a biological medicine for chronic inflammation helps improve how the heart works. Eligibility: Adults ages 18 and older who have moderate to severe psoriasis, and healthy adult volunteers. Design: Participants will be screened with a medical history. They may take a pregnancy test. Healthy volunteers will have 1 visit. Those with psoriasis will have a second visit 1 year later. Participants may give blood samples. They may have a heart function test. They may have a heart imaging test, and may get a contrast agent. If so, it will be injected into a vein. Participants may have positron emission tomography/computed tomography tests. They will lie on their back on a padded table with their arms straight overhead. They may get radioactive drugs through an intravenous (IV) catheter. They will get stress medicines through the

  • IV. These drugs mimic exercise and increase blood flow through the heart.
Participants may have cardiac magnetic resonance imaging. The scanner is a large tube. Participants will lie on a table that slides in and out of the tube. They will get gadolinium contrast in a vein to improve the pictures. They may get stress medicines. Coils will be used to help make the pictures. Participation for healthy volunteers will last 1-2 days. Participation for those with psoriasis will last 14 months. ...

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

  • -

    INCLUSION CRITERIA:

    Subjects of both genders will be considered for inclusion in this study.
There will be no racial, ethnic, or gender discrimination. Affected Subjects:
  • - 18 years of age or older.
  • - Diagnosed with moderate-severe psoriasis clinically confirmed by a licensed physician, or advanced practitioner consisting of typical skin findings and/or associated findings of systemic disease of joints, nails, and hair and may be scheduled to initiate biologic.
treatment for psoriasis. Healthy Controls: Females and males 18 years of age or older.

EXCLUSION CRITERIA:

Affected Subjects:
  • - Pregnant or lactating women.
  • - Subjects with a contraindication to MRI scanning will not receive the CMR assessment.
These contraindications include subjects with the following devices: i. Central nervous system aneurysm clips. ii. Implanted neural stimulator. iii. Implanted cardiac pacemaker or defibrillator. iv. Cochlear implant. v. Ocular foreign body (e.g. metal shavings) vi. Implanted Insulin pump. vii. Metal shrapnel or bullet. viii. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2 body surface area according to the Modification of Diet in Renal Disease criteria.
  • - History of seizures or taking anti-epileptic medications.
  • - Inability to provide informed consent.
Healthy Controls:
  • - Diagnosis of inflammatory disease (including psoriasis, psoriatic arthritis, rheumatoid arthritis, lupus, inflammatory bowel disease) - Pregnant women and lactating women.
  • - Subjects with a contraindication to MRI scanning will not receive the CMR assessment.
These contraindications include subjects with the following devices: ix. Central nervous system aneurysm clips. x. Implanted neural stimulator. xi. Implanted cardiac pacemaker or defibrillator. xii. Cochlear implant. xiii. Ocular foreign body (e.g. metal shavings) xiv. Implanted Insulin pump. xv. Metal shrapnel or bullet. xvi. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2 body surface area according to the Modification of Diet in Renal Disease criteria.
  • - History of seizures or taking anti-epileptic medications.
- Inability to provide informed consent

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04870827
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Michael N Sack, M.D.
Principal Investigator Affiliation National Heart, Lung, and Blood Institute (NHLBI)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis
Study Website: View Trial Website
Additional Details

Study Description: Heart failure (HF) remains a significant public health burden despite expanding and improving treatment options. Clinical and pre-clinical studies have demonstrated compelling relationships between inflammation, myocardial dysfunction, HF and adverse clinical outcomes. In this study to be conducted at the NIH Clinical Center, we propose to utilize psoriasis as a disease model to study how chronic inflammation effects myocardial perfusion, measured by myocardial flow reserve (MFR) on positron emission tomography (PET) and cardiac MRI (CMR), and myocardial function and tissue composition measured by multi-modality cardiovascular imaging. Objectives: 1. To test the hypothesis that chronic inflammation is a driver of perturbances in myocardial perfusion, function, and tissue composition. 2. To test the hypothesis that biologic treatment for psoriasis will be associated with longitudinal improvement in myocardial perfusion, function, and tissue composition. 3. To characterize immune cell subsets and their association with myocardial perfusion, function, and tissue composition in chronic inflammation. 4. To explore how chronic inflammation may alter myocardial energetics and metabolism. Endpoints: Primary outcomes will be: Myocardial perfusion, as assessed by myocardial flow reserve (MFR), in subjects with moderate to severe psoriasis compared to matched healthy controls. Secondary outcomes will be: Change in MFR in subjects with psoriasis on biologic therapy at 1 year follow-up compared to baseline. Diastolic function (on echocardiogram), myocardial mechanics (on echocardiogram and CMR), myocardial edema and inflammation, and interstitial fibrosis (on CMR) in subjects with moderate to severe psoriasis compared to matched healthy controls. Change in diastolic function, myocardial mechanics, myocardial edema and inflammation, and interstitial fibrosis in subjects with psoriasis on biologic therapy at 1 year follow- up. Exploratory outcomes will be: Immune cell subsets by flow cytometry in subjects with 7 moderate to severe psoriasis compared to matched healthy controls. Rest and stress left ventricular oxygen consumption (MVO2) in subjects with moderate to severe psoriasis compared to matched healthy controls

Arms & Interventions

Arms

: Affected Subjects

Subjects diagnosed with moderate- severe psoriasis

: Healthy Controls

Females and males 18 years of age or older

Interventions

Contact a Trial Team

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Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

prpl@cc.nih.gov

800-411-1222 #TTY8664111010

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