Trial · NCT03554291

Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension

NCT03554291, Phase 2, Completed, University of Washington; results first posted 2024-08-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension. Trials, record NCT03554291. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03554291

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Trial

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

Title: Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension
NCT number: NCT03554291
Status: Completed
Phases: Phase 2
Enrollment: 80 participants, actual
Lead sponsor: University of Washington
Conditions: Pulmonary Arterial Hypertension, Right Heart Failure
Interventions: Famotidine 20 MG, Placebo
First posted: 2018-06-13
Last updated: 2024-08-09
Results first posted: 2024-08-09

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	Change in Six-minute Walk Distance	0 to 24 weeks	To determine whether famotidine increases six-minute walk distance at 24 weeks in men and women with pulmonary arterial hypertension
Secondary	Chang in Log-transformed BNP	0 to 24 weeks	To determine whether famotidine reduces log-transformed BNP at 24 weeks
Secondary	Proportion of Participants With New York Heart Association (NYHA) Functional Class of I or II at Week 24	24 weeks	NYHA functional class is graded from 1 to 4 (1: no symptoms of heart failure; 2: symptoms of heart failure with moderate exertion; 3: symptoms of heart failure with mild exertion; 4: symptoms of heart failure at rest). As such, NYHA functional class 1 is considered better than NYHA functional class 4.
Secondary	Change in Right Ventricular Morphology by Echocardiogram (RV Dilation and TAPSE)	0 to 24 weeks	To determine whether famotidine improves right ventricular morphology at 24 weeks including improved right ventricular dilation and TAPSE
Secondary	Change in Health Related Quality of Life (emPHasis-10 Questionnaire)	0 to 24 weeks	To determine whether famotidine improves health related quality of life as estimated by the emPHasis-10 score (Each item on the emPHasis-10 questionnaire is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end; EmPHasis-10 scores range from 0 to 50 with higher scores indicating worse quality of life).
Secondary	Percent of Participants by Arm Who Added PAH Focused Care (Increased Diuretics, Escalating Doses of Pulmonary Vasodilators, and/or Adding Additional Pulmonary Vasodilators) Over 24 Weeks.	0 to 24 weeks	To determine whether famotidine decreases the need to escalate PAH focused care (increased diuretics, escalating doses of pulmonary vasodilators, and/or adding an additional pulmonary vasodilator). The confidence interval includes a negative percent (e.g. a participant who de-escalated care).
Other	Invasive Hemodynamics (Sub-study): Stroke Volume Index	0 to 24 weeks	To determine whether famotidine increases stroke volume index at 24 weeks
Other	Cardiopulmonary Exercise Testing (Sub-study): Maximal Oxygen Uptake	0 to 24 weeks	To determine whether famotidine increases maximal oxygen uptake in individuals with pulmonary arterial hypertension at 24 weeks
Other	Invasive Hemodynamics (Sub-study): Hemodynamics	0 to 24 weeks	Exploratory: To explore whether famotidine improves hemodynamics (wedge, RA, PVR) at 24 weeks
Other	Cardiopulmonary Exercise Testing (Sub-study): Exercise	0 to 24 weeks	Exploratory: To explore whether famotidine improves exercise (Ve/VCO2 ratio, total achieved wattage).

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change in Six-minute Walk Distance	0 to 24 weeks	meters	LEAST_SQUARES_MEAN
SECONDARY	Chang in Log-transformed BNP	0 to 24 weeks	Log of pg/mL	LEAST_SQUARES_MEAN
SECONDARY	Proportion of Participants With New York Heart Association (NYHA) Functional Class of I or II at Week 24	24 weeks	Proportion participants NYHA class I/II	NUMBER
SECONDARY	Change in Right Ventricular Morphology by Echocardiogram (RV Dilation and TAPSE)	0 to 24 weeks	RV basal diameter (cm)/TAPSE (mm)	LEAST_SQUARES_MEAN
SECONDARY	Change in Health Related Quality of Life (emPHasis-10 Questionnaire)	0 to 24 weeks	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percent of Participants by Arm Who Added PAH Focused Care (Increased Diuretics, Escalating Doses of Pulmonary Vasodilators, and/or Adding Additional Pulmonary Vasodilators) Over 24 Weeks.	0 to 24 weeks	model-based percentage of participants	NUMBER
OTHER_PRE_SPECIFIED	Invasive Hemodynamics (Sub-study): Stroke Volume Index	0 to 24 weeks
OTHER_PRE_SPECIFIED	Cardiopulmonary Exercise Testing (Sub-study): Maximal Oxygen Uptake	0 to 24 weeks
OTHER_PRE_SPECIFIED	Invasive Hemodynamics (Sub-study): Hemodynamics	0 to 24 weeks
OTHER_PRE_SPECIFIED	Cardiopulmonary Exercise Testing (Sub-study): Exercise	0 to 24 weeks

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Category	Value	Spread	Units
Change in Six-minute Walk Distance	Famotidine		-17.0	95% Confidence Interval -43.6 to 9.7	meters
Change in Six-minute Walk Distance	Placebo		4.7	95% Confidence Interval -20.1 to 29.6	meters
Chang in Log-transformed BNP	Famotidine		-0.05	95% Confidence Interval -0.16 to 0.26	Log of pg/mL
Chang in Log-transformed BNP	Placebo		0.08	95% Confidence Interval -0.12 to 0.27	Log of pg/mL
Proportion of Participants With New York Heart Association (NYHA) Functional Class of I or II at Week 24	Famotidine		0.71	95% Confidence Interval 0.54 to 0.85	Proportion participants NYHA class I/II
Proportion of Participants With New York Heart Association (NYHA) Functional Class of I or II at Week 24	Placebo		0.53	95% Confidence Interval 0.36 to 0.69	Proportion participants NYHA class I/II
Change in Right Ventricular Morphology by Echocardiogram (RV Dilation and TAPSE)	Famotidine	RV dilation	-1.5	95% Confidence Interval -3.2 to 0.3	RV basal diameter (cm)/TAPSE (mm)
Change in Right Ventricular Morphology by Echocardiogram (RV Dilation and TAPSE)	Placebo	RV dilation	0.9	95% Confidence Interval -0.9 to 2.6	RV basal diameter (cm)/TAPSE (mm)
Change in Right Ventricular Morphology by Echocardiogram (RV Dilation and TAPSE)	Famotidine	TAPSE	0.1	95% Confidence Interval -1.2 to 1.3	RV basal diameter (cm)/TAPSE (mm)
Change in Right Ventricular Morphology by Echocardiogram (RV Dilation and TAPSE)	Placebo	TAPSE	0.7	95% Confidence Interval -0.6 to 1.9	RV basal diameter (cm)/TAPSE (mm)

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Famotidine	41
Overall Study	STARTED	Placebo	39
Overall Study	COMPLETED	Famotidine	34
Overall Study	COMPLETED	Placebo	38
Overall Study	NOT COMPLETED	Famotidine	7
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events44

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	Abdominal pain, dyspepsia, nausea, flatulence, discomfort	Gastrointestinal disorders	Famotidine	8	40	8
other	Abdominal pain, dyspepsia, nausea, flatulence, discomfort	Gastrointestinal disorders	Placebo	5	39	5
other	Coronavirus, Influenza, Medical Device site infection, Ear infection, Metapneumovirus, Nasopharyngit	Infections and infestations	Famotidine	8	40	8
other	Coronavirus, Influenza, Medical Device site infection, Ear infection, Metapneumovirus, Nasopharyngit	Infections and infestations	Placebo	4	39	4
other	Syncope, Dizziness, Headache, Dysgeusia, Encephalopathy	Nervous system disorders	Famotidine	5	40	5
other	Syncope, Dizziness, Headache, Dysgeusia, Encephalopathy	Nervous system disorders	Placebo	1	39	1
other	non-cardiac chest pain, swelling	General disorders	Famotidine	2	40	2
other	non-cardiac chest pain, swelling	General disorders	Placebo	0	39	0
other	dyspnea, hemoptysis, throat irritation	Respiratory, thoracic and mediastinal disorders	Famotidine	4	40	4
other	dyspnea, hemoptysis, throat irritation	Respiratory, thoracic and mediastinal disorders	Placebo	1	39	1

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Famotidine	2	40
Total, all-cause mortality	Placebo	1	39
Total, other adverse events	Famotidine	20	40
Total, other adverse events	Placebo	14	39
Total, serious adverse events	Famotidine	9	40
Total, serious adverse events	Placebo	4	39

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25295642	BACKGROUND	PubMed
27150686	BACKGROUND	PubMed
29191567	BACKGROUND	PubMed
29437490	BACKGROUND	PubMed
39761829	DERIVED	PubMed

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
R61HL142539	REHAB-PH Trial: Repurposing a Histamine Antagonist to Benefit Patients with Pulmonary Hypertension	LEARY, PETER J	UNIVERSITY OF WASHINGTON	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2018

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Famotidine vs Placebo: deaths from any cause	Trial comparisons
Famotidine 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/NCT03554291

GET https://conductscience.org/api/trials/v1/NCT03554291/events?page=2

API reference For AI assistants