Trial · NCT04112316

Developing Oral LT3 Therapy for Heart Failure - HFrEF

NCT04112316, Phase 1, Phase 2, Completed, University of Pennsylvania; results first posted 2024-12-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Developing Oral LT3 Therapy for Heart Failure - HFrEF. Trials, record NCT04112316. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04112316

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Developing Oral LT3 Therapy for Heart Failure - HFrEF
NCT number: NCT04112316
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 28 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: Heart Failure With Reduced Ejection Fraction (HFrEF), Low T3 Syndrome
Interventions: Liothyronine, Placebo
First posted: 2019-10-02
Last updated: 2024-12-24
Results first posted: 2024-12-24

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Cardiac Rhythm Monitoring by 14 Day Patch Rhythm Assessment	continuous during intervention (14 days)	Number of participants with atrial fibrillation or ventricular tachycardia \>= 4 beats
Primary	T3 Level	8 weeks	Number of participants with T3 levels above upper limit of reference range
Secondary	Change in Peak Maximal Rate of Oxygen Consumption During Exercise (VO2 Max)	8 weeks	Change in peak rate of oxygen consumption during exercise between baseline and 8 weeks
Secondary	Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life	8 weeks	Change in KCCQ from baseline to 8 weeks, 0-100 scale, higher is better
Secondary	Activity Measured Via Actigraphy	8 weeks	Remotely sensed minutes/day of cumulative light, moderate, or vigorous activity in minutes/day after 8 weeks of LT3 or placebo
Secondary	Change in NT-proBNP Levels	8 weeks	Change in B-type natriuretic peptide levels, Pg/mL, from baseline to 8 weeks

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Cardiac Rhythm Monitoring by 14 Day Patch Rhythm Assessment	continuous during intervention (14 days)	Number of participants with events	NUMBER
PRIMARY	T3 Level	8 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Peak Maximal Rate of Oxygen Consumption During Exercise (VO2 Max)	8 weeks	ml/kg/min	MEAN
SECONDARY	Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life	8 weeks	units on a scale	MEAN
SECONDARY	Activity Measured Via Actigraphy	8 weeks	minutes/day	MEAN
SECONDARY	Change in NT-proBNP Levels	8 weeks	pg/mL	MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Cardiac Rhythm Monitoring by 14 Day Patch Rhythm Assessment	Liothyronine (LT3)	11		Number of participants with events
Cardiac Rhythm Monitoring by 14 Day Patch Rhythm Assessment	Placebo	19		Number of participants with events
T3 Level	Liothyronine (LT3)	4		Participants
T3 Level	Placebo	0		Participants
Change in Peak Maximal Rate of Oxygen Consumption During Exercise (VO2 Max)	Liothyronine (LT3)	11.18	Standard Deviation 4.24	ml/kg/min
Change in Peak Maximal Rate of Oxygen Consumption During Exercise (VO2 Max)	Placebo	10.78	Standard Deviation 4.31	ml/kg/min
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life	Liothyronine (LT3)	0.6	Standard Deviation 6.8	units on a scale
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life	Placebo	-0.6	Standard Deviation 10.3	units on a scale
Activity Measured Via Actigraphy	Liothyronine (LT3)	241	Standard Deviation 83	minutes/day
Activity Measured Via Actigraphy	Placebo	265	Standard Deviation 82	minutes/day

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Period (8 Weeks)	STARTED	Liothyronine (LT3), Then Placebo	14
First Period (8 Weeks)	STARTED	Placebo, Then Liothyronine	14
First Period (8 Weeks)	COMPLETED	Liothyronine (LT3), Then Placebo	12
First Period (8 Weeks)	COMPLETED	Placebo, Then Liothyronine	14
First Period (8 Weeks)	NOT COMPLETED	Liothyronine (LT3), Then Placebo	2
First Period (8 Weeks)	NOT COMPLETED	Placebo, Then Liothyronine	0
Washout (2 Weeks)	STARTED	Liothyronine (LT3), Then Placebo	12
Washout (2 Weeks)	STARTED	Placebo, Then Liothyronine	14
Washout (2 Weeks)	COMPLETED	Liothyronine (LT3), Then Placebo	12
Washout (2 Weeks)	COMPLETED	Placebo, Then Liothyronine	14

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Total	Investigations	Liothyronine (LT3)	15	28	25
other	Total	Investigations	Placebo	9	28	20

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Liothyronine (LT3)	0	28
Total, all-cause mortality	Placebo	0	28
Total, other adverse events	Liothyronine (LT3)	15	28
Total, other adverse events	Placebo	9	28
Total, serious adverse events	Liothyronine (LT3)	0	28
Total, serious adverse events	Placebo	0	28

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R61HL146390	Developing Oral LT3 Therapy for Heart Failure	CAPPOLA, ANNE R; CAPPOLA, THOMAS P.; CHIRINOS MEDINA, JULIO ALONSO	UNIVERSITY OF PENNSYLVANIA	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2019

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Liothyronine (LT3) vs Placebo: T3 Level	Trial comparisons
Liothyronine (LT3) vs Placebo: deaths from any cause	Trial comparisons
Liothyronine (LT3) vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04112316

GET https://conductscience.org/api/trials/v1/NCT04112316/registered

API reference For AI assistants