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Trial record 19 of 29 for:    Pulmonary Hypertension OR Vascular dementia OR Vascular Dementia OR Vascular Contributions to Cognitive Impairment and Dementia | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Pulmonary Hypertension and Anastrozole Trial (PHANTOM)

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ClinicalTrials.gov Identifier: NCT03229499
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : November 11, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University
University of Colorado, Denver
Rhode Island Hospital
Stanford University
Vanderbilt University
Washington University School of Medicine
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Anastrozole Drug: Placebo Oral Tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021


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:

  • adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
  • first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
  • treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.
Other Name: Arimidex

Placebo Comparator: Placebo
1 tablet taken by mouth once a day for one year
Drug: Placebo Oral Tablet
matching placebo tablet




Primary Outcome Measures :
  1. Difference in changes in distance walked in six minutes between anastrozole and placebo groups [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Difference in changes in distance walked in six minutes between anastrozole and placebo groups [ Time Frame: 3 months, 12 months ]
  2. Difference in right ventricular function between anastrozole and placebo groups [ Time Frame: 6 months, 12 months ]
  3. Difference in changes in plasma NT-proBNP level between anastrozole and placebo groups [ Time Frame: 3 months, 6months,12 months ]
  4. Difference in changes in biomarkers between anastrozole and placebo groups [ Time Frame: 3 months, 6months,12 months ]
  5. Difference in changes in SF36 between anastrozole and placebo groups [ Time Frame: 3 months, 6months,12 months ]
  6. Difference in changes in emPHasis-10 between anastrozole and placebo groups [ Time Frame: 3 months, 6months,12 months ]
  7. Difference in changes in actigraphy-measured physical activity between anastrozole and placebo groups [ Time Frame: 3 months, 6months,12 months ]
  8. Difference in time-to-clinical worsening (TTCW) between anastrozole and placebo groups [ Time Frame: 12 months ]
  9. Difference in changes in bone mineral density between anastrozole and placebo groups [ Time Frame: 12 months ]
  10. Difference in side effects between anastrozole and placebo groups at twelve months [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Diane Pinder 215-294-9757 pinder@pennmedicine.upenn.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Patricia Del Rosario, RN    650-721-2408    pdelrosa@stanford.edu   
Principal Investigator: Roham Zamanian, MD         
United States, Colorado
University of Colorado - Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Cheri Abott, RN, CCRP       Cheryl.Abbott@ucdenver.edu   
Principal Investigator: Todd Bull, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21218
Contact: Dezeray Cephas    410-502-4362    cephas1@jhu.edu   
Contact: Victoria Stackhouse       vstackh1@jhu.edu   
Principal Investigator: Stephen Mathai, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Sharon Heuerman, RN    314-747-8174    sheuerman@wustl.edu   
Principal Investigator: Murali Chakinala, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Tess LaPatra    215-294-9755    Tess.Lapatra@Pennmedicine.upenn.edu   
Contact: Diane Pinder    215-294-9757    pinder@pennmedicine.upenn.edu   
Principal Investigator: Steven Kawut, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
East Providence, Rhode Island, United States, 02914
Contact: Heather Morreo    401-444-2733    HMorreo@Lifespan.org   
Contact: Brynn Normandin       BNormandin@Lifespan.org   
Principal Investigator: Corey Ventetuolo, MD         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Shannon Cordell, RN    615-343-8277    shannon.eason@Vanderbilt.Edu   
Principal Investigator: Anna Hemnes, MD         
Sponsors and Collaborators
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University
University of Colorado, Denver
Rhode Island Hospital
Stanford University
Vanderbilt University
Washington University School of Medicine
Investigators
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Principal Investigator: Steven M Kawut, MD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03229499     History of Changes
Other Study ID Numbers: 827486
R01HL134905 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: November 2019

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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
Keywords provided by University of Pennsylvania:
Randomized Controlled Trial
clinical trial
anastrozole
pulmonary hypertension
pulmonary arterial hypertension
PAH
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Lung Diseases
Cardiovascular 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