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Thyroid Hormone
Liothyronine (LT3) for Heart Failure (DOT3HF-HFrEF 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
An implantable cardioverter-defibrillator (ICD)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up continuous during intervention (14 days)
Awards & highlights
DOT3HF-HFrEF Trial Summary
This trial is testing whether thyroid hormone therapy can help people with heart failure and low T3 levels.
Eligible Conditions
- Heart Failure with Reduced Ejection Fraction
- Hypothyroidism
DOT3HF-HFrEF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have an implanted device called an implantable cardioverter-defibrillator (ICD).
DOT3HF-HFrEF 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-HFrEF 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.
Find a Location
Who is running the clinical trial?
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
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
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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of liver disease called cirrhosis.You are using a left ventricular assist device (LVAD).You were hospitalized for heart failure within the last month.You have had a heart-related procedure or surgery in the past 2-6 months.You have an implanted device called an implantable cardioverter-defibrillator (ICD).You are unable to complete a specific exercise test called VO2max.You are taking medications or have gastrointestinal conditions that can interfere with the absorption or metabolism of thyroid hormone.You have a serious problem with your heart valves that has not been fixed yet.
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.
What aims is this research endeavor striving to fulfill?
"This 14-day clinical trial has one primary aim: achieving T3 Level. Secondary objectives include measuring NT-proBNP, Quality of Life through the KCCQ scale, and VO2 Max peak rate of oxygen consumption during exercise."
Answered by AI
How many participants is this research endeavor accommodating?
"Affirmative. According to information published on clinicaltrials.gov, this medical study is still seeking patients to enroll in their trial. The initial posting date was February 11th 2020 and the listing has been updated most recently on August 2nd 2022; the investigators are looking for 28 individuals across a single site."
Answered by AI
Are there any open enrollments for this medical experiment currently?
"This medical study, which was first shared on 2nd November 2020 is presently enrolling participants. Clinicaltrials.gov's records confirm that the trial has been updated as recently as 8th August 2022."
Answered by AI
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