Pulmonary Hypertension and Anastrozole Trial (PHANTOM)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03229499 |
Recruitment Status :
Completed
First Posted : July 25, 2017
Last Update Posted : October 21, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Arterial Hypertension | Drug: Anastrozole Drug: Placebo Oral Tablet | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 84 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Pulmonary Hypertension and Anastrozole Trial (PHANTOM) |
Actual Study Start Date : | December 7, 2017 |
Actual Primary Completion Date : | July 22, 2022 |
Actual Study Completion Date : | July 22, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Anastrozole
1mg (1 tablet)taken by mouth once a day for one year
|
Drug: Anastrozole
Anastrozole is an aromatase inhibitor indicated for:
Other Name: Arimidex |
Placebo Comparator: Placebo
1 tablet taken by mouth once a day for one year
|
Drug: Placebo Oral Tablet
matching placebo tablet |
- Difference in changes in distance walked in six minutes between anastrozole and placebo groups [ Time Frame: 6 months ]
- Difference in changes in distance walked in six minutes between anastrozole and placebo groups [ Time Frame: 3 months, 12 months ]
- Difference in right ventricular function between anastrozole and placebo groups [ Time Frame: 6 months, 12 months ]
- Difference in changes in plasma NT-proBNP level between anastrozole and placebo groups [ Time Frame: 3 months, 6months,12 months ]
- Difference in changes in biomarkers between anastrozole and placebo groups [ Time Frame: 3 months, 6months,12 months ]
- Difference in changes in SF36 between anastrozole and placebo groups [ Time Frame: 3 months, 6months,12 months ]
- Difference in changes in emPHasis-10 between anastrozole and placebo groups [ Time Frame: 3 months, 6months,12 months ]
- Difference in changes in actigraphy-measured physical activity between anastrozole and placebo groups [ Time Frame: 3 months, 6months,12 months ]
- Difference in time-to-clinical worsening (TTCW) between anastrozole and placebo groups [ Time Frame: 12 months ]
- Difference in changes in bone mineral density between anastrozole and placebo groups [ Time Frame: 12 months ]
- Difference in side effects between anastrozole and placebo groups at twelve months [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previous documentation of mean pulmonary artery pressure > 25 mm Hg with a pulmonary capillary wedge pressure (or left ventricular end-diastolic pressure) < 16 mm Hg and PVR > 3 WU at any time before study entry.
- Diagnosis of PAH which is idiopathic, heritable, drug- or toxin-induced, or associated with connective tissue disease, congenital heart disease, portal hypertension, or HIV infection and receiving treatment for PAH.
- Most recent pulmonary function tests with FEV1/FVC >50% AND either a) total lung capacity > 70% predicted or b) total lung capacity between 60% and 70% predicted with no more than mild interstitial lung disease on computerized tomography scan of the chest.
- Ability to perform six minute walk testing without significant limitations in musculoskeletal function or coordination.
-
If female, post-menopausal state, defined as:
- > 50 years old and a) have not menstruated during the preceding 12 months or b) have follicle-stimulating hormone (FSH) levels (> 40 IU/L) or
- < 50 years and FSH (> 40 IU/L) or
- having had a bilateral oophorectomy.
- Informed consent.
Exclusion Criteria:
- Age < 18.
- Current treatment with estrogen, hormone therapy, or anti-hormone therapy (tamoxifen, fulvestrant, etc.)
- WHO Class IV functional status.
- History of invasive breast cancer.
- Clinically significant untreated sleep apnea.
- Left-sided valvular disease (more than moderate mitral valve stenosis or insufficiency or aortic stenosis or insufficiency), pulmonary artery or valve stenosis, or ejection fraction < 45% on most recent echocardiography (within 1 year).
- Initiation of PAH therapy (prostacyclin analogues, endothelin-1 receptor antagonists, phosphodiesterase-5 inhibitors, riociguat, selexipag) within three months of enrollment; the dose must be stable for at least three months prior to Baseline Visit. PAH therapy which is stopped and then restarted or has dose changes which are not related to initiation and uptitration will be allowed within 3 months prior to the Baseline Visit.
- Hospitalized or acutely ill.
- Renal failure (creatinine ≥ 2.0).
- Hypercalcemia.
- Severe osteoporosis: T score -2.5 to -3.4 without bone modifying treatment OR T score = - 3.5 or lower
- Child-Pugh Class C cirrhosis.
- Current or recent (< 3 months) chronic heavy alcohol consumption.
- Enrollment in a clinical trial or concurrent use of another investigational drug or device within 30 days of screening visit.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229499
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 | |
United States, Colorado | |
University of Colorado - Denver | |
Aurora, Colorado, United States, 80045 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21218 | |
United States, Missouri | |
Washington University | |
Saint Louis, Missouri, United States, 63130 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Rhode Island | |
Rhode Island Hospital | |
East Providence, Rhode Island, United States, 02914 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Steven M Kawut, MD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT03229499 |
Other Study ID Numbers: |
827486 R01HL134905 ( U.S. NIH Grant/Contract ) |
First Posted: | July 25, 2017 Key Record Dates |
Last Update Posted: | October 21, 2022 |
Last Verified: | October 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Randomized Controlled Trial clinical trial anastrozole |
pulmonary hypertension pulmonary arterial hypertension PAH |
Hypertension, Pulmonary Pulmonary Arterial Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Anastrozole Antineoplastic Agents, Hormonal |
Antineoplastic Agents Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |