Trial · NCT04111536

Developing Oral LT3 Therapy for Heart Failure - HFpEF

NCT04111536, Phase 1, Phase 2, Completed, University of Pennsylvania; results first posted 2025-01-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Developing Oral LT3 Therapy for Heart Failure - HFpEF. Trials, record NCT04111536. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04111536

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 - HFpEF
NCT number: NCT04111536
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 28 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: Heart Failure With Preserved Ejection Fraction, Low Triiodothyronine Syndrome
Interventions: liothyronine, Placebo
First posted: 2019-10-01
Last updated: 2025-01-08
Results first posted: 2025-01-08

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Atrial Fibrillation or Ventricular Tachycardia >=4 Beats	continuous during intervention (14 days)	Number with atrial fibrillation or ventricular tachycardia \>=4 beats
Primary	T3 Level	8 weeks	Number of participant T3 levels above upper limit of reference range
Secondary	Peak Maximal Rate of Oxygen Consumption During Exercise (VO2 Max)	8 weeks	Peak rate of oxygen consumption at 8 weeks
Secondary	Measure of Quality of Life	8 weeks	Change in Kansas City Cardiomyopathy Questionnaire, KCCQ scale of 0 to 100, higher score is better outcome, from baseline to 8 weeks
Secondary	Actigraphy	8 weeks	Remotely sensed minutes/day of cumulative light, moderate or vigorous activity after 8 weeks of LT3 or placebo
Secondary	NT-proBNP Levels	8 weeks	Change in B-type natriuretic peptide, 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	Number of Participants With Atrial Fibrillation or Ventricular Tachycardia >=4 Beats	continuous during intervention (14 days)	Number of participants with events	NUMBER
PRIMARY	T3 Level	8 weeks	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Peak Maximal Rate of Oxygen Consumption During Exercise (VO2 Max)	8 weeks	ml/kg/min	MEAN
SECONDARY	Measure of Quality of Life	8 weeks	score on a scale	MEAN
SECONDARY	Actigraphy	8 weeks	minutes/day	MEAN
SECONDARY	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
Number of Participants With Atrial Fibrillation or Ventricular Tachycardia >=4 Beats	Liothyronine (LT3)	10		Number of participants with events
Number of Participants With Atrial Fibrillation or Ventricular Tachycardia >=4 Beats	Placebo	12		Number of participants with events
T3 Level	Liothyronine (LT3)	7		Participants
T3 Level	Placebo	0		Participants
Peak Maximal Rate of Oxygen Consumption During Exercise (VO2 Max)	Liothyronine (LT3)	9.53	Standard Deviation 3.42	ml/kg/min
Peak Maximal Rate of Oxygen Consumption During Exercise (VO2 Max)	Placebo	10.07	Standard Deviation 3.40	ml/kg/min
Measure of Quality of Life	Liothyronine (LT3)	0.1	Standard Deviation 11.5	score on a scale
Measure of Quality of Life	Placebo	0.5	Standard Deviation 11.1	score on a scale
Actigraphy	Liothyronine (LT3)	224	Standard Deviation 70	minutes/day
Actigraphy	Placebo	230	Standard Deviation 78	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 Intervention (8 Weeks)	STARTED	Liothyronine (LT3), Then Placebo	14
First Intervention (8 Weeks)	STARTED	Placebo, Then Liothyronine	14
First Intervention (8 Weeks)	COMPLETED	Liothyronine (LT3), Then Placebo	14
First Intervention (8 Weeks)	COMPLETED	Placebo, Then Liothyronine	12
First Intervention (8 Weeks)	NOT COMPLETED	Liothyronine (LT3), Then Placebo	0
First Intervention (8 Weeks)	NOT COMPLETED	Placebo, Then Liothyronine	2
Washout (2 Weeks)	STARTED	Liothyronine (LT3), Then Placebo	14
Washout (2 Weeks)	STARTED	Placebo, Then Liothyronine	12
Washout (2 Weeks)	COMPLETED	Liothyronine (LT3), Then Placebo	14
Washout (2 Weeks)	COMPLETED	Placebo, Then Liothyronine	12

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events6

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	General	General disorders	Liothyronine (LT3)	10	28	18
other	General	General disorders	Placebo	15	28	24
serious	stroke	Vascular disorders	Liothyronine (LT3)	0	28	0
serious	stroke	Vascular disorders	Placebo	1	28	1
serious	heart failure	Cardiac disorders	Liothyronine (LT3)	0	28	0
serious	heart failure	Cardiac disorders	Placebo	1	28	1

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)	10	28
Total, other adverse events	Placebo	15	28
Total, serious adverse events	Liothyronine (LT3)	0	28
Total, serious adverse events	Placebo	2	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/NCT04111536

GET https://conductscience.org/api/trials/v1/NCT04111536/registered

API reference For AI assistants