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3. Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial

Author

Adir, Yochai, Baillie, Timothy, Baratz, David, Burger, Charles, Chakinala, Murali M., Cifrián Martínez, Jose Manual, Delcroix, Marion, Dwyer, Nathan, Elwing, Jean M., Fisher, Micah, Franco, Veronica, Grünig, Ekkehard, Highland, Kristin, Hill, Nicholas, Hirani, Naushad, Hoeper, Marius, Jansa, Pavel, Keogh, Anne, Kingrey, John, Lopez-Meseguer, Manuel, McConnell, John W., Mehta, Sanjay, Melendres-Groves, Lana, Opitz, Christian, Pepke-Zaba, Joanna, Pillutla, Priya, Rahaghi, Franck, Raina, Amresh, Raviv, Yael, Robinson, Jeffrey, Ryan, John, Sager, Jeffrey, Shapiro, Shelley, Simon, Marc, Smith, Kerri, Sobol, Irina R., Sood, Namita, Spikes, Leslie A., Stadler, Stefan, Stevens, Wendy, Sulica, Roxana, White, R. James, Frantz, Robert P, McLaughlin, Vallerie V, Sahay, Sandeep, Escribano Subías, Pilar, Zolty, Ronald L, Benza, Raymond L, Channick, Richard N, Chin, Kelly M, Hemnes, Anna R, Howard, Luke S, Sitbon, Olivier, Vachiéry, Jean-Luc, Zamanian, Roham T, Cravets, Matt, Roscigno, Robert F, Mottola, David, Osterhout, Robin, Bruey, Jean-Marie, Elman, Erin, Tompkins, Cindy-ann, Parsley, Ed, Aranda, Richard, Zisman, Lawrence S, and Ghofrani, Hossein-Ardeschir

Published
2024
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11. Exploring the Influence of Contextual Factors and the Caregiving Process on Caregiver Burden and Quality of Life Outcomes of Heart Failure (HF) Dyads after a Hospital Discharge: A Mixed-Methods Study.

Author

Oliver, Tamara L., Hetland, Breanna, Schmaderer, Myra, Zolty, Ronald, Wichman, Christopher, and Pozehl, Bunny

Subjects
CAREGIVERS, BURDEN of care, HEART failure, SOCIAL isolation, QUALITY of life
Abstract

Background: This study explores heart failure (HF) dyadic contextual factors and caregiver burden during acute exacerbation hospitalization and discharge. Methods: It employed a mixed-methods approach, with HF dyads completing questionnaires and semi-structured interviews at a one-week post-discharge outpatient visit. Quantitative tools included the SF-12 Quality of Life, Zarit Burden Interview (ZBI), Bakas Caregiving Outcomes Scale (BCOS), and Self-Care of Heart Failure Index v. 6 (SCHFI). Thematic analysis was conducted on interview data to assess caregiver burden, disease trajectory, comorbidities, caregiving time, and employment status. Results: Twelve HF dyads participated, with caregivers (six female, six male) averaging 65.76 years. The ZBI indicated a low caregiver burden (median score of 15), but qualitative data revealed a higher perceived burden related to social isolation, future fears, and caregiver dependence. Male caregivers reported a lower burden than females. Positive goal congruence was noted in caregiving hours and HF management compliance. HF patients had a 10-year survival prediction of 22.75% per the Charlson Comorbidity Index, with 69% in NYHA class III and an average ejection fraction of 37.7%. Caregivers working full-time and caring for higher NYHA-class patients showed higher ZBI and BCOS scores. Conclusions: The study highlights the need for mixed methods and longitudinal research to understand HF disease trajectory and caregiver burden, emphasizing the importance of including caregivers in HF education and screening for perceived burden to improve outcomes and reduce re-hospitalizations. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Seralutinib in adults with pulmonary arterial hypertension (TORREY): a randomised, double-blind, placebo-controlled phase 2 trial.

Author

Frantz, Robert P, McLaughlin, Vallerie V, Sahay, Sandeep, Escribano Subías, Pilar, Zolty, Ronald L, Benza, Raymond L, Channick, Richard N, Chin, Kelly M, Hemnes, Anna R, Howard, Luke S, Sitbon, Olivier, Vachiéry, Jean-Luc, Zamanian, Roham T, Cravets, Matt, Roscigno, Robert F, Mottola, David, Osterhout, Robin, Bruey, Jean-Marie, Elman, Erin, and Tompkins, Cindy-ann

Subjects
PULMONARY arterial hypertension, C-kit protein, MACROPHAGE colony-stimulating factor, PLATELET-derived growth factor receptors, VASCULAR remodeling, COUGH, PULMONARY hypertension
Abstract

Morbidity and mortality in pulmonary arterial hypertension (PAH) remain high. Activation of platelet-derived growth factor receptor, colony stimulating factor 1 receptor, and mast or stem cell growth factor receptor kinases stimulates inflammatory, proliferative, and fibrotic pathways driving pulmonary vascular remodelling in PAH. Seralutinib, an inhaled kinase inhibitor, targets these pathways. We aimed to evaluate the efficacy and safety of seralutinib in patients with PAH receiving standard background therapy. The TORREY trial was a phase 2, randomised, multicentre, multinational, double-blind, placebo-controlled study. Patients with PAH from 40 hospital and community sites were randomly assigned 1:1 via interactive response technologies to receive seralutinib (60 mg twice daily for 2 weeks, then increased to 90 mg twice daily as tolerated) or placebo by dry powder inhaler twice daily for 24 weeks. Randomisation was stratified by baseline pulmonary vascular resistance (PVR; <800 dyne·s/cm5 and ≥800 dyne·s/cm5). Patients were eligible if classified as WHO Group 1 PH (PAH), WHO Functional Class II or III, with a PVR of 400 dyne·s/cm5 or more, and a 6 min walk distance of between 150 m and 550 m. The primary endpoint was change in PVR from baseline to 24 weeks. Analyses for efficacy endpoints were conducted in randomly assigned patients (intention-to-treat population). Safety analyses included all patients who received the study drug. TORREY was registered with ClinicalTrials.gov (NCT04456998) and EudraCT (2019-002669-37) and is completed. From Nov 12, 2020, to April 20, 2022, 151 patients were screened for eligibility, and following exclusions, 86 adults receiving PAH background therapy were randomly assigned to seralutinib (n=44; four male, 40 female) or placebo (n=42; four male, 38 female), and comprised the intention-to-treat population. At baseline, treatment groups were balanced except for a higher representation of WHO Functional Class II patients in the seralutinib group. The least squares mean change from baseline to week 24 in PVR was 21·2 dyne·s/cm5 (95% CI −37·4 to 79·8) for the placebo group and −74·9 dyne·s/cm5 (−139·7 to −10·2) for the seralutinib group. The least squares mean difference between the seralutinib and placebo groups for change in PVR was −96·1 dyne·s/cm5 (95% CI −183·5 to −8·8; p=0·03). The most common treatment-emergent adverse event in both treatment groups was cough: 16 (38%) of 42 patients in the placebo group; 19 (43%) of 44 patients in the seralutinib group. Treatment with inhaled seralutinib significantly decreased PVR, meeting the primary endpoint of the study among patients receiving background therapy for PAH. Gossamer Bio. [ABSTRACT FROM AUTHOR]

Published
2024
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18. RISK STATUS IMPROVEMENTS OBSERVED AFTER PARENTERAL INDUCTION AND TRANSITION TO ORAL TREPROSTINIL: A POST-HOC ANALYSIS OF THE EXPEDITE STUDY USING THE 4-STRATA RISK MODEL

Author

FRANCO, VERONICA, primary, MILLER, CHAD, additional, BALASUBRAMANIAN, VIJAY, additional, KINGREY, JOHN F, additional, ZOLTY, RONALD, additional, OUDIZ, RONALD J, additional, MELENDRES-GROVES, LANA, additional, HUSTON, JESSICA, additional, RAVICHANDRAN, ASHWIN, additional, CELLA, DANA, additional, SEAMAN, SCOTT, additional, THRASHER, CLAIRE, additional, BRODERICK, MEREDITH, additional, and M. ELWING, JEAN, additional

Published
2023
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21. Implementing the EXPEDITE parenteral induction protocol: Rapid parenteral treprostinil titration and transition to oral treprostinil

Author

Kingrey, John F., primary, Miller, Chad E., additional, Franco, Veronica, additional, Smith, Jimmy S., additional, Zolty, Ronald, additional, Oudiz, Ronald J., additional, Elwing, Jean M., additional, Huston, Jessica H., additional, Melendres‐Groves, Lana, additional, Ravichandran, Ashwin, additional, Balasubramanian, Vijay, additional, Wu, Benjamin, additional, Hwang, Stephanie, additional, Seaman, Scott, additional, Broderick, Meredith, additional, and Rahaghi, Franck F., additional

Published
2023
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49. sj-docx-1-jao-10.1177_03913988221112684 – Supplemental material for Impact of digoxin utilization on clinical outcomes following left ventricular assist device implantation

Author

Abbasi, Muhannad Aboud, Stoller, Douglas A, Lyden, Elizabeth, Lowes, Brian D, Zolty, Ronald, and Lundgren, Scott W

Subjects
FOS: Biological sciences, 69999 Biological Sciences not elsewhere classified
Abstract

Supplemental material, sj-docx-1-jao-10.1177_03913988221112684 for Impact of digoxin utilization on clinical outcomes following left ventricular assist device implantation by Muhannad Aboud Abbasi, Douglas A Stoller, Elizabeth Lyden, Brian D Lowes, Ronald Zolty and Scott W Lundgren in The International Journal of Artificial Organs

Published
2022
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