Heart Failure Clinical Trial
Official title:
Effects of Triiodothyronine (T3) in Ischemic Heart Failure
This study aims to determine whether giving triiodothyronine (T3), a thyroid hormone, is safe and helps improve symptoms and signs of heart failure. The study is divided into 2 phases. In the first phase, participants have a 50-50 chance of receiving the study drug. Participants who are enrolled to receive the study drug will be admitted to the General Clinical Research Center (GCRC) for 5 days for oral thyroid hormone treatment and monitoring. They will have 4 additional follow-up visits over the next year. Participants who are not enrolled to receive the study drug will not be admitted but will have similar follow-up visits in the outpatient setting. Participants who do not receive the drug in Phase I will have the opportunity to enroll in Phase II of the study where everyone will receive the thyroid hormone treatment. If this study finds that patients have improved heart function after treatment with thyroid hormone without unacceptable side effects, this could result in a new treatment for patients with heart failure.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Aged 18-80 years, male or female; - Confirmed diagnosis of ischemic HF with left ventricular ejection fraction (LVEF) = 40% (measured by echocardiography within 1 month of Screening); - Stable symptoms; NYHA class II-III without recent admission (1 month) for acute decompensation; - Receiving guideline-based standard HF therapies at the maximum tolerated doses for >1 month. Patients on other beta-blockers will be switched to metoprolol succinate at equivalent doses for 3 weeks. - Presence of ICD for >1 month or implantable cardiac resynchronization therapy defibrillator (CRT-D) for >3 months - Understand and sign the informed consent form. Exclusion Criteria: - LVEF > 40%; - Unremitting atrial fibrillation during the screening period or clinically significant ventricular tachycardia (on ICD interrogation); - Non-ischemic HF including hypertrophic cardiomyopathy, peripartum or chemotherapy-induced cardiomyopathy, other non-ischemic cardiomyopathies, constrictive pericarditis, significant and uncorrected valvular heart disease (severe regurgitation or severe stenosis or valvular disease requiring surgery), congenital heart disease, primary pulmonary hypertension or secondary severe pulmonary hypertension (= 70 mmHg); large pericardial or pleural effusions; right heart failure due to lung disease; - Recent admission (1 month) for acute decompensated HF; - Angina pectoris, cerebrovascular accident, myocardial infarction, revascularization (PCI or other surgery), carotid artery or other large vessel surgery, or cardiac resynchronization therapy (CRT) implant within the past 3 months; - Planned revascularization within 6 months; - History of heart transplantation, use of ventricular assist device (VAD) or preparation for heart transplantation, VAD; - Liver dysfunction (bilirubin or alkaline phosphatase > 2 times the upper limit of normal (ULN), aspartate aminotransferase or alanine aminotransferase > 3 times the upper limit of normal), estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease Study (MDRD) method < 30 ml/min/1.73 m2; - Systolic blood pressure < 90 mmHg or > 160 mmHg; - Blood K+ < 3.2 mmol/L or > 5.5 mmol/L; - Women of childbearing age who are planning to become pregnant within 2 years, and pregnant or lactating women; - Patients whose survival time is expected to be less than 6 months as judged by the investigator; - Those who have participated in any drug clinical trial within the previous 3 months; - Severe neurological disorders (Alzheimer's disease, progressive parkinsonism); - The subjects with a history of cancer that limits life expectancy to <1 year; - Endocrine disorders include thyroid disease, thyroid replacement therapy, pheochromocytoma, thyromegaly, etc. - The subject, in the judgment of the Investigator, is unable to complete the study or to comply with the requirements of the study (for administrative or other reasons); - Prisoners; - Adults unable to consent; |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital (EUH) | Atlanta | Georgia |
United States | Emory University Hospital Clinical Research Network | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in the Left ventricular end-systolic volume (LVESV) and Left ventricular end-diastolic volume (LVEDV) | An echocardiogram will be performed at specific study visits and LVESV and LVEDV will be measured. | Baseline, Day 45, Day 90 | |
Other | Changes Left ventricular end-systolic volume index (LVESVI) and end-diastolic volume index (LVEDVI) | An echocardiogram will be performed at specific study visits and LVESVI and LVEDVI will be measured. | Baseline, Day 45, Day 90 | |
Other | Changes in the LV posterior wall (LVPW) thickness by speckle-tracking echocardiography | An echocardiogram will be performed at specific study visits where the LV posterior wall (LVPW) thickness by 2D echocardiography (longitudinal and circumferential strain and strain rate). | Baseline, Day 45, Day 90 | |
Other | Changes in longitudinal and circumferential strain by speckle-tracking echocardiography | An echocardiogram will be performed at specific study visits where longitudinal and circumferential strain will be measured by 2D echocardiography (and strain rate). | Baseline, Day 45, Day 90 | |
Other | Changes in the strain rate by speckle-tracking echocardiography | An echocardiogram will be performed at specific study visits where the strain rate will be measured by 2D echocardiography | Baseline, Day 45, Day 90 | |
Other | Composite of all-cause mortality | The total number of subject deaths after the first week of treatment up to 12 months will be recorded | After 1 week of study drug administration up to 12 months | |
Other | Number of participants with hospital admission due to acute coronary syndrome (ACS) and all-cause HF admissions after first week | Participants will be asked about any ACS and HF hospital admission during each study visit, in addition, electronic medical records (EMR) will be reviewed periodically to document any ACS and HF hospital admission. | After 1 week of study drug administration up to 12 months | |
Primary | Changes in the presence of clinical arrhythmias | An electrocardiogram will be performed during each study visit and the presence of any Clinical arrhythmias such as ectopy, atrial fibrillation, ventricular arrhythmias, ICD firing will be documented. *Days 1 through 5 apply only to those who are admitted to the GCRC unit. | Baseline, Days 1*, 2*, 3*, 4*, 5*, 6 weeks, 3 months, 6 months, 12 months | |
Primary | The number of participants with Angina, acute coronary syndrome, death during the first week | The total number of subject's events during the first week of the treatment period will be recorded | During the first week of treatment period | |
Secondary | Change in left ventricular ejection fraction (LVEF) | An echocardiogram will be performed at specific study visits and LVEF will be measured | Baseline, Day 45, Day 90 | |
Secondary | Change in 6-minute walk distance (6MWD) | Two 6-minute walk tests will be completed at least 2 hours apart to establish a baseline. The mean of the 2 distances will be used as the baseline. The six-minute walk test requires a 100-ft hallway. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. The six-minute walk test serves as a standardized test for functional capacity quantification of HF patients and is predictive of adverse cardiovascular outcomes. Most patients do not achieve maximal exercise capacity during the 6-minute walk test; instead, they choose their own intensity of exercise and can stop and rest during the test. | Baseline, Day 45, Day 90 | |
Secondary | Changes in New York Heart Association (NYHA) classification | Participants will be asked about exertional symptoms for NYHA functional categorization of HF symptoms at all time points. Symptom-based scores range from I to IV. The NYHA classification system also includes an objective assessment of cardiovascular disease severity, which ranges from A-D. Differences between treatment and control arms over time will be analyzed as well as within arms over time. | Baseline, Day 45, Day 90 | |
Secondary | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) | This is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and quality of life limitation due to HF. Scores range from 0 to 100. For the KCCQ overall summary score, a small but clinically meaningful change is = 5 points. | Baseline, Day 45, Day 90 | |
Secondary | Changes in Brain natriuretic peptide (BNP) levels | -B-type natriuretic peptide (BNP) will be measured at specific study visits. Differences between treatment and control arms over time will be analyzed as well as within arms over time. | Baseline, Day 45, Day 90 |
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