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Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension
Phase 2 trial testing Famotidine 20 MG in Pulmonary Arterial Hypertension in 80 participants. Completed in 11 July 2023.
| Lead sponsor | University of Washington |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 May 2019 |
| Primary completion | 11 July 2023 |
| Estimated completion | 11 July 2023 |
| Sites | 1 location across United States |
University of Washington
Adults 18 to 80, any sex, with Pulmonary Arterial Hypertension or Right Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To determine whether famotidine increases six-minute walk distance at 24 weeks in men and women with pulmonary arterial hypertension
| Group | Value | 95% CI |
|---|---|---|
| Famotidine | -17.0 | -43.6 – 9.7 |
| Placebo | 4.7 | -20.1 – 29.6 |
To determine whether famotidine reduces log-transformed BNP at 24 weeks
| Group | Value | 95% CI |
|---|---|---|
| Famotidine | -0.05 | -0.16 – 0.26 |
| Placebo | 0.08 | -0.12 – 0.27 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Famotidine | 0.71 | 0.54 – 0.85 |
| Placebo | 0.53 | 0.36 – 0.69 |
To determine whether famotidine improves right ventricular morphology at 24 weeks including improved right ventricular dilation and TAPSE
| Group | Value | 95% CI |
|---|---|---|
| Famotidine | -1.5 | -3.2 – 0.3 |
| Placebo | 0.9 | -0.9 – 2.6 |
| Group | Value | 95% CI |
|---|---|---|
| Famotidine | 0.1 | -1.2 – 1.3 |
| Placebo | 0.7 | -0.6 – 1.9 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Famotidine | -1.7 | -4.2 – 0.8 |
| Placebo | -1.3 | -3.9 – 1.2 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Famotidine | 8.1 | -0.3 – 18.9 |
| Placebo | 5.3 | -1.8 – 12.5 |
Time frame: Adverse events were collected over 24 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Famotidine | Placebo |
|---|---|---|---|
| Coronavirus, Medical Device Site Infection, Metapneumovirus, Pneumonia | Infections and infestations | — | — |
| Atrial flutter, Angina Pectoris, Cardiac Failure | Cardiac disorders | — | — |
| syncope, encephalopathy | Nervous system disorders | — | — |
| Dehydration, Hypokalemia | Metabolism and nutrition disorders | — | — |
| Acute Kidney Injury | Renal and urinary disorders | — | — |
| Dyspnea, Hemoptysis | Respiratory, thoracic and mediastinal disorders | — | — |
| Device malfunction | Product Issues | — | — |
| Hypotension | Vascular disorders | — | — |
| Reaction | System | Famotidine | Placebo |
|---|---|---|---|
| Abdominal pain, dyspepsia, nausea, flatulence, discomfort | Gastrointestinal disorders | — | — |
| Coronavirus, Influenza, Medical Device site infection, Ear infection, Metapneumovirus, Nasopharyngit | Infections and infestations | — | — |
| Syncope, Dizziness, Headache, Dysgeusia, Encephalopathy | Nervous system disorders | — | — |
| dyspnea, hemoptysis, throat irritation | Respiratory, thoracic and mediastinal disorders | — | — |
| angina, atrial flutter, cardiac failure | Cardiac disorders | — | — |
| non-cardiac chest pain, swelling | General disorders | — | — |
| dehydration, hypokalemia | Metabolism and nutrition disorders | — | — |
| acute kidney injury, | Renal and urinary disorders | — | — |
| back pain, bursitis, neck pain | Musculoskeletal and connective tissue disorders | — | — |
| rash | Skin and subcutaneous tissue disorders | — | — |
| ligament strain, muscle strain | Injury, poisoning and procedural complications | — | — |
| device malfunction | Product Issues | — | — |
| vaginal hemorrhage | Reproductive system and breast disorders | — | — |
| hypotension | Vascular disorders | — | — |
Most-reported serious reactions: Coronavirus, Medical Device Site Infection, Metapneumovirus, Pneumonia, Atrial flutter, Angina Pectoris, Cardiac Failure, syncope, encephalopathy, Dehydration, Hypokalemia, Acute Kidney Injury, Dyspnea, Hemoptysis, Device malfunction, Hypotension.
Data from ClinicalTrials.gov NCT03554291 adverse events section.
This is a Phase 2, single-center, randomized placebo controlled trial of famotidine (an H2 receptor antagonist) in adults with pulmonary arterial hypertension. The study will evaluate the safety and clinical efficacy of a 24-week course of famotidine.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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