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Pulmonary Hypertension and Anastrozole Trial
Phase 2 trial testing Anastrozole in Pulmonary Arterial Hypertension in 84 participants. Completed in 22 July 2022.
| Lead sponsor | University of Pennsylvania |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 84 |
| Start date | 7 December 2017 |
| Primary completion | 22 July 2022 |
| Estimated completion | 22 July 2022 |
| Sites | 7 locations across United States |
University of Pennsylvania
18 and older, any sex, with Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in the distance walked in six minutes adjusted for baseline value and sex
| Group | Value | 95% CI |
|---|---|---|
| Anastrozole | 1.53 | -15.92 – 18.99 |
| Placebo | 9.45 | -8.64 – 27.54 |
Change in tricuspid annular systolic plane excursion (TAPSE) adjusted for baseline value and sex. TAPSE is a measure of right ventricular function that is measured via cardiac echography
| Group | Value | 95% CI |
|---|---|---|
| Anastrozole | -0.97 | -2.39 – 0.45 |
| Placebo | -0.08 | -1.46 – 1.30 |
Change in log10 NT-proBNP adjusted for baseline value and sex
| Group | Value | 95% CI |
|---|---|---|
| Anastrozole | 0.06 | -0.04 – 0.15 |
| Placebo | 0.04 | -0.06 – 0.14 |
Change in the Medical Outcomes Study Questionnaire Short Form-36 (SF36) physical component summary (PCS) score adjusted for baseline value and sex. SF36 PCS score is a subjective measure of physical health status, with scores ranging from 0 to 100. Higher scores represent better health status.
| Group | Value | 95% CI |
|---|---|---|
| Anastrozole | 1.38 | -0.34 – 3.10 |
| Placebo | 0.02 | -1.76 – 1.79 |
Change in the emPHasis-10 score adjusted for baseline value and sex. EmPHasis-10 is a pulmonary hypertension-specific measure of quality of life which is scored from 0-50, with higher scores indicating worse quality of life.
| Group | Value | 95% CI |
|---|---|---|
| Anastrozole | -0.27 | -2.34 – 1.81 |
| Placebo | -0.51 | -2.68 – 1.66 |
Actigraphy-measured vector magnitude count is an estimate of physical activity intensity. The total vector magnitude counts per day was measured over 7 days using an actigraphy device, and the median value over the 7 days was obtained. This outcome measure is the change in the 7-day median value from baseline to follow-up, adjusted for the baseline value, sex, and actigraphy device wear time.
| Group | Value | 95% CI |
|---|---|---|
| Anastrozole | -0.43 | -0.69 – -0.18 |
| Placebo | -0.28 | -0.55 – 0 |
Number of participants with a clinical worsening event. Clinical worsening was defined as the addition of new PAH therapies or dose increases in previously stable PAH therapy for increased symptoms, hospitalization for PAH progression and/or right-sided heart failure, lung transplantation, atrial septostomy, or all-cause death.' Unit of Measure is retained as 'Participants.
| Group | Value | 95% CI |
|---|---|---|
| Anastrozole | 7 | |
| Placebo | 8 |
Change in lumbar spine bone mineral density adjusted for baseline value and sex between anastrozole and placebo groups
| Group | Value | 95% CI |
|---|---|---|
| Anastrozole | 0 | -0.02 – 0.01 |
| Placebo | 0 | -0.02 – 0.02 |
Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Anastrozole | Placebo |
|---|---|---|---|
| Catheter placement | Surgical and medical procedures | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — |
| Heart Failure | Cardiac disorders | — | — |
| Anaphylaxis | Immune system disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Carcinoma hepatocellular | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Cardiac arrest | Cardiac disorders | — | — |
| Chest pain - cardiac | Cardiac disorders | — | — |
| Chronic leg ulcer | Skin and subcutaneous tissue disorders | — | — |
| Coronavirus infection | Infections and infestations | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Disease progression | General disorders | — | — |
| Esophagitis | Gastrointestinal disorders | — | — |
| Fluid overload | Metabolism and nutrition disorders | — | — |
| Fluid retention in tissues | Metabolism and nutrition disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Mallory Weiss tear | Gastrointestinal disorders | — | — |
| Paresthesia | Nervous system disorders | — | — |
| Pelvic mass | General disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | — | — |
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Anastrozole | Placebo |
|---|---|---|---|
| Upper respiratory infection | Infections and infestations | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Hot flashes | Vascular disorders | — | — |
| Edema limbs | General disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Depression | Psychiatric disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Fatigue | General disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Vaginal dryness | Reproductive system and breast disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Palpitations | Cardiac disorders | — | — |
| Presyncope | Nervous system disorders | — | — |
| Vertigo | Ear and labyrinth disorders | — | — |
Most-reported serious reactions: Catheter placement, Dyspnea, Hypoxia, Heart Failure, Anaphylaxis, Anemia, Carcinoma hepatocellular, Cardiac arrest.
Data from ClinicalTrials.gov NCT03229499 adverse events section.
The primary objectives of this study are to determine whether the study drug, anastrozole may improve six minute walk distance at six months compared to placebo and to assess safety and side effects up to twelve months in pulmonary arterial hypertension (PAH).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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