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Thyroid Hormone
Liothyronine (LT3) for Heart Failure (DOT3HF-HFpEF Trial)
Phase 1 & 2
Waitlist Available
Led By Anne R Cappola, MD,ScM
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continuous during intervention (14 days)
Awards & highlights
DOT3HF-HFpEF Trial Summary
This trial is investigating whether thyroid hormone therapy with Liothyronine is safe and effective in people with heart failure and low triiodothyronine levels.
Eligible Conditions
- Diastolic Heart Failure
- Hypothyroidism
DOT3HF-HFpEF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ continuous during intervention (14 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~continuous during intervention (14 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiac Rhythm Monitoring by 14 day Patch Rhythm Assessment
T3 Level
Secondary outcome measures
Actigraphy
Measure of Quality of Life
NT-proBNP Levels
+1 moreDOT3HF-HFpEF Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Liothyronine (LT3)Active Control1 Intervention
Liothyronine (L-triiodothyronine or LT3) in the 5 mcg tablet dose formulation. Minimum LT3 dose will be 2.5 mcg three times daily and the maximum LT3 dose will be 12.5 mcg three times daily.
Group II: PlaceboPlacebo Group1 Intervention
A placebo tablet matching in appearance to LT3 tablets, dosed equivalently. Minimum placebo tablet dose will be 1/2 tablet (2.5 mcg equivalent) three times daily and the maximum placebo dose will be 2 1/2 tablets (12.5 mcg equivalent) three times daily.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,060 Total Patients Enrolled
42 Trials studying Heart Failure
7,486 Patients Enrolled for Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,306,468 Total Patients Enrolled
206 Trials studying Heart Failure
677,420 Patients Enrolled for Heart Failure
Anne R Cappola, MD,ScMPrincipal InvestigatorUniversity of Pennsylvania
1 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Heart Failure
28 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of liver disease called cirrhosis.You are taking medications that can affect how your body absorbs or processes thyroid hormone.You regularly take a certain type of medication called loop diuretics to help manage your symptoms.Based on a score, there is a high chance that you have a condition called HFpEF (heart failure with preserved ejection fraction) and there doesn't seem to be any other obvious reason for your symptoms, as determined by the doctor.You had a heart attack, heart procedure, or heart surgery within the past 2 months.You have stomach or intestinal conditions that make it hard for your body to absorb thyroid hormone.You are unable to do a test that measures your maximum oxygen consumption during exercise.You were hospitalized for heart failure in the last month.You have a heart condition called hypertrophic or restrictive cardiomyopathy, or a severe problem with one of your heart valves that has not been fixed.
Research Study Groups:
This trial has the following groups:- Group 1: Liothyronine (LT3)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any patients currently being accepted into this trial?
"Yes, this is an active recruitment according to the information on clinicaltrials.gov. The study was posted on March 8th, 2020 and was last updated August 18th, 2020. They are looking for 28 patients from 1 site."
Answered by AI
What are the main goals of this clinical trial?
"The purpose of this study is to observe the changes over a two-week period in order to assess the efficacy of the medication. Additionally, we will also be measuring NT-proBNP Levels, Quality of Life, and Actigraphy data to get a more well-rounded understanding of the effects of the intervention."
Answered by AI
How many volunteers are participating in this clinical trial?
"That is accurate. According to the information available on clinicaltrials.gov, this study is still looking for participants. The posting went up on March 8th 2020 and was last edited on August 18th 2022. So far, only 28 people have signed up across 1 location."
Answered by AI
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