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UCSF Cardiology
Transforming medicine through innovation and collaboration.
Department of Medicine

Heart Failure and Pulmonary Hypertension Research

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Title: Aurora
Principal Investigator: Liviu Klein, MD, MS
Purpose: An observational study to explore the use of portable device sensors as noninvasive assessment of arterial pressures and left ventricular filling pressures
Funding: To determine if changes in the aortic, femoral, and radial pressures (augmentation index, pulse pressure) obtained invasively via routine cardiac catheterization are correlated with the pressures obtained noninvasively with the Aurora wristband. To determine the added prognostic value of objectively measured physiological response captured by the Aurora wristband during mild physical activity or standard care with the clinical and functional measures of heart failure status.

Title: MCS A-QOL
Principal Investigator: Liviu Klein, MD, MS
Purpose: Mechanical Circulatory Support: Measures of Adjustment and Quality of Life
Funding: To develop a measurement system to assess adjustment to mechanical circulatory support (MCS) implant and health-related quality of life (HRQOL) in patients with advanced heart failure (HF) who undergo surgery.

Title: Tremolo
Principal Investigator: Liviu Klein, MD, MS
Purpose: Tremolo: An observational study to explore the vibrations and sounds of the body that occur with each heartbeat.
Funding: To learn the correlations between various non-invasive sensor data and events of the heart beat.

Ongoing Participation in Multicenter Clinical Trial and Registries

Title: ATTRACT Extension
Principal Investigator: Teresa De Marco, MD, FACC
Purpose: A Phase 3 Multicenter, Randomized, Double-blind, Extension Study To Evaluate the Safety of Daily Dosing Of Tafamidis Meglumine (Pf-06291826) 20 Mg or 80 Mg in Subjects Diagnosed With Transthyretin Cardiomyopathy (ttr-cm)
Funding: To evaluate the safety of oral daily dosing of 20 mg or 80 mg tafamidis meglumine in subjects with either transthyretin genetic variants or wild-type transthyretin resulting in amyloid cardiomyopathy.

Title: Lariat
Principal Investigator: Teresa De Marco, MD, FACC
Purpose: A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension
Funding: This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with pulmonary hypertension to determine the recommended dose range, evaluate the change from baseline in 6-minute walk distance (6MWD) and determine the effect of Bardoxolone methyl in pulmonary hypertension associated with connective tissue disease, interstitial lung disease, and idiopathic etiologies, including subsets of patients with WHO Group III or WHO Group V PH following 16 weeks of study participation.

Title: SOPRANO-HF
Principal Investigator: Munir Janmohamed, MD
Purpose: A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Macitentan in Patients With Pulmonary Hypertension After Left Ventricular Assist Device Implantation
Funding: To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) as compared to placebo in subjects with pulmonary hypertension (PH) after left ventricular assist device (LVAD) implantation.

Title: BEAT-HF
Principal Investigator: Liviu Klein, MD, MS
Purpose: Barostim Neo® - Baroreflex Activation Therapy® for Heart Failure
3. The purpose of this clinical trial is to develop valid scientific evidence for safety and effectiveness of Baroreflex Activation Therapy™ with the Barostim neo system in subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy, excluding subjects eligible for or with a Cardiac Resynchronization Therapy (CRT) device.

Title: REPORT-HF
Principal Investigator: Liviu Klein, MD, MS
Purpose: International Registry to assess mEdical Practice with lOngitudinal obseRvation for Treatment of Heart Failure (REPORT-HF)
Funding: he proposed observational study is a multinational HF-disease registry that will document the routine patterns of diagnosis and medical care for heart failure as well as treatment type, long-term HF-related clinical events, and re-admission rates following the acute admission index event.

Title: SMILE
Principal Investigator: Liviu Klein, MD, MS
Purpose: Sensible Medical Innovations Lung fluid status monitor allows rEducing readmission rate of heart failure patients- a randomized controlled study SMILE
Funding: To determine if a significant decrease in the rate of heart failure (HF) rehospitalizations occurs during the entire follow-up period when ReDS guided treatment is used as an adjunct to standard of care (SOC).

Title: CardioMEMs
Principal Investigator: Van Selby, MD
Purpose: CardioMEMS HF System Post Approval Study
Funding: The purpose of this Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting.