Status:
WITHDRAWN
The Effect of Inflammation in Heart Failure
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Myocardial Dysfunction
Heart Failure
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
Background: Heart failure is a serious health condition. Researchers believe inflammation plays a role. They want to see if adding an additional heart drug to a person s treatment can help treat hear...
Detailed Description
Study Description: Heart failure (HF) remains a significant public health burden. Unlike heart failure with reduced ejection fraction (HFrEF), heart failure with preserved ejection fraction (HFpEF) c...
Eligibility Criteria
Inclusion
- 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:
- 18years of age or older
- Diagnosed with HFpEF clinically confirmed by licensed physician or advanced practitioner
- Signs and symptoms of HFpEF
- LVEF \>= 50% on echocardiography from screening visit
- Left ventricular hypertrophy (interventricular septal thickness (Bullet) 1cm) or enlarged left atrial volume ( (Bullet)34ml/m2) on echocardiography from screening visit
- NT-proBNP \> 300pg/mL
- Healthy Controls:
- Females and males 18 years of age or older
- EXCLUSION CRITERIA:
- Affected Subjects:
- Pregnant or lactating women
- Acute coronary syndrome, cardiac surgery or percutaneous coronary intervention within past 6 months
- Atrial fibrillation
- Coronary artery disease with \>= 50% stenosis in the left main, left anterior descending artery, left circumflex artery, or right coronary artery on CCTA from screening visit
- Infiltrative cardiomyopathy by diagnosis or imaging
- \> Moderate valvular stenosis on screening echocardiography
- Diagnosis of an inflammatory disease (including psoriasis, psoriatic arthritis, rheumatoid arthritis, lupus, inflammatory bowel disease, HIV)
- Currently taking an SGLT2 inhibitor
- Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73m\^2 body surface area according to the Modification of Diet in Renal Disease criteria
- 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
- History of seizures or taking anti-epileptic medications
- History of serious hypersensitivity to dapagliflozin
- History of diabetic ketoacidosis
- Inability to provide informed consent
- Healthy Controls:
- History of HF
- Acute coronary syndrome, cardiac surgery or percutaneous coronary intervention within past 6 months
- Coronary artery disease with \>= 50% stenosis in the left main, left anterior descending artery, left circumflex artery, or right coronary artery on CCTA
- Diagnosis of an inflammatory disease (including psoriasis, psoriatic arthritis, rheumatoid arthritis, lupus, inflammatory bowel disease, HIV)
- Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73m\^2 body surface area according to the Modification of Diet in Renal Disease criteria
- 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:
- viii. Central nervous system aneurysm clips
- ix. Implanted neural stimulator
- x. Implanted cardiac pacemaker or defibrillator
- xi. Cochlear implant
- xii. Ocular foreign body (e.g. metal shavings)
- xiii. Implanted Insulin pump
- xiv. Metal shrapnel or bullet
- History of seizures or taking anti-epileptic medications
- Inability to provide informed consent
Exclusion
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05330013
Start Date
June 23 2022
End Date
June 23 2022
Last Update
June 27 2022
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892