Heart Failure and Pulmonary Hypertension Research

Ongoing UCSF Investigator-Initiated Studies

Ongoing Participation in Multicenter Clinical Trial and Registries

Title: A Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE).
Principal Investigator: Ted Abraham, MD
Purpose: This multicenter study is a long-term extension of Study MYK-461-006 (MAVERICK-HCM) to assess long-term safety, tolerability, and efficacy of mavacamten in participants with nHCM who completed MAVERICK-HCM, and participants with oHCM who completed the EXPLORER-HCM.

Title: Comparison of Respirix’s noninvasive Pulmonary Artery Compliance during and after decompensation in Heart Failure Patients
Principal Investigator: Ted Abraham, MD
Purpose: Daily Pulmonary Artery Compliance measurements will be obtained with the Respirix device upon admission to the hospital for congestive heart failure decompensation. 

Title: REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in Obstructive Outflow Disease in HCM
Principal Investigator: Ted Abraham, MD
Purpose: This study is being performed to understand the effect of different doses of CK-3773274 on patients with oHCM.

Title: SOPRANO: Macitentan in Pulmonary Hypertension Post-Left Ventricular Assist Device Implantation
Principal Investigator: Mandar Aras, MD
Purpose: SOPRANO is a prospective, double-blind, placebo-controlled, multicenter, parallel-group Phase 2 study assessing the safety and efficacy of macitentan in the treatment of pulmonary hypertension post-LVAD implantation. 

Title: Proactive
Principal Investigator: Mandar Aras, MD
Purpose: A Prospective, Multi-Center, Randomized, Controlled, Single Blind Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class III Heart Failure Patients

Title: Open-Label Study of AG10 in Patients With Cardiomyopathy
Principal Investigator: Mandar Aras, MD
Purpose: An Open-Label Extension and Safety Monitoring Study of Patients With Symptomatic Transthyretin Cardiomyopathy Who Have Completed the Phase II Study AG10-201

Title: PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH)
Principal Investigator: Mandar Aras, MD
Purpose: This is a multicenter double-blind, placebo-controlled study to evaluate the safety, efficacy and pharmacokinetics of 2 doses of CXA-10 on stable background therapy in 96 subjects 18 to 80 years of age with PAH.

Title: Destination Therapy (DT) Post Approval Study (PAS)
Principal Investigator: Mandar Aras, MD
Purpose: DT-PAS (Destination Therapy Post-Approval Study), and the sub-study Apogee, is a prospective, observational, multi-site study collecting clinical data from Destination Therapy (DT) patients treated with an eligible Medtronic Left Ventricular Assist Device. 

TtileTROPHY II
Principal Investigator: Richard Cheng, MD
Purpose: This is a prospective, multi-center, non-randomized study which uses the Therapeutic Intra Vascular UltraSound (TIVUS) System to treat patients with pulmonary artery hypertension by denervating the sympathetic nerves surround the pulmonary vasculature using ultrasonic energy.  
Sponsor / Funder: SoniVie Inc.

Title: Decongestive Therapy for ARVC
Principal Investigator: Melvin Scheinman, MD Liviu Klein, MD
Purpose: To assess the combined used of Diuretics and Nitrates therapy on Right Ventricular size and function in patients with ARVC
Funding source: Deb foundation grant  

Title: Right Ventricular strain patterns in asymptomatic relatives of probands with ARVC
Principal Investigator: Melvin Scheinman, MD, Nelson Schiller, MD
Purpose: To assess the role of serial RV strain Echos in phenotype negative and genotype positive relatives of probands with ARVC
Funding source: Deb Foundation

Pulmonary Hypertension Trials Open to Patients

TitlePULSAR (ACE-011)
Principal Investigator: Teresa De Marco, MD
Purpose: A Phase II, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Satotercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH), WHO functional class II or III. 
Sponsor / Funder: Acceleron Pharma Inc.

Title: SOPRANO
Principal Investigator: Van Selby, 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. 
Sponsor / Funder: Acetlion Pharmaceuticals US, Inc. 
https://www.clinicaltrials.gov/ct2/show/NCT02554903

Title: Uptravi (Selexipag): The Users Drug Registry
Principal Investigator: Van Selby, MD
Purpose: This multi-center, prospective, observational drug registry is developed to further characterize the clinical characteristics, clinical outcomes and dosing regimens of patients treated with Uptravi in routine clinical practice.
Sponsor / Funder: Acetlion Pharmaceuticals US, Inc.   
https://www.clinicaltrials.gov/ct2/show/NCT03278002

Amyloid Clinical Trials Open to Patients

Title: Tafamidis B3461045
Principle Investigator: Teresa De Marco, MD
Sub-Investigator: Dr. Van Selby, MD
Purpose: Phase III multicenter, randomized, double-blind extension study to evaluate the safety of daily oral dosing of tafamidis meglumine (PF-06291826) 20mg or 80 mg in subjects diagnosed with transthyretin cardiomyopathy (TTR-CM)
Sponsor / Funder: Pfizer 
https://www.clinicaltrials.gov/ct2/show/NCT02791230

Title: EIDOS AG10-101
Principal Investigator: Van Selby, MD
Purpose: Collect blood samples of different variant TTRs in the sera and plasma from ATTR patients (or relatives with different TTR genotypes) to assess the TTR binding and stabilizing properties of study drug AG10.
Sponsor / Funder: Eidos Therapeutics, Inc. 

Title: EIDOS AG10-201
Principal Investigator: Van Selby, MD
Purpose: A phase II multicenter, randomized, placebo-controlled, dose-ranging study of the safety, tolerability, pharmacokinetics and pharmacodynamics of AG10 in patients with symptomatic transthyretin amyloid cardiomyopathy.
Sponsor / Funder: Eidos Therapeutics, Inc. 
https://www.clinicaltrials.gov/ct2/show/NCT03458130

Title: EIDOS AG10-202
Principal Investigator: Van Selby, MD
Purpose: Multicenter, open-label extension and safety monitoring study of patients with symptomatic transthyretin cardiomyopathy who completed the parent study AG10-201.
Sponsor / Funder: Eidos Therapeutics, Inc.
https://www.clinicaltrials.gov/ct2/show/NCT03536767

 Heart Failure Trials Open to Patients 

Title: MyLeukoMAP FDA-Pivotal Trial
Principal Investigator: Teresa De Marco, MD
Purpose: Observation, non-randomized, multicenter study to assess a molecular blood test which examines peripheral blood mononuclear cell gene expression and it’s use in assisting clinicians in advanced heart failure patients to more precisely diagnose peri-interventional functional recovery potential as a surrogate marker for one-year survival.
Sponsor / Funder: LeukoLifeDx 

Title: Tailored Drug Titration Through Artificial Intelligence (ARTERY)
Principal Investigator: Liviu Klein, MD
Purpose: ARTERY Is a randomized clinical trial that investigates the benefit of a predictive modeling artificial intelligence in improving the management of anti-hypertensive medication treatment.
Sponsor / Funder: National Institutes of Health (NIH)
https://clinicaltrials.gov/ct2/show/NCT03397524

Title: Baroreflex Activation Therapy for Heart Failure (BeAT-HF)
Principal Investigator: Liviu Klein, MD
Purpose: The purpose of this multi-center, randomized clinical trial is to develop evidence for safety and effectiveness of Baroreflex Activation Therapy with the BAROSTIM NEO System in patients with NYHA Class III heart failure, a left ventricular ejection fraction (LVEF) less than 35% and where optimal medication management has been unsuccessful symptomatically.
Sponsor / Funder: CVRx, INC. 
https://clinicaltrials.gov/ct2/show/NCT02627196 

Title: MCS A-QOL
Principal Investigator: Liviu Klein, MD
Purpose: The purpose of this study is to develop a measurement system to assess adjustment to mechanical circulatory support (MCS) (also referred to as a ventricular assist device [VAD]) and health-related quality of life (HRQOL) in patients with advanced heart failure who receive a VAD. This investigators refer to this measurement system as Mechanical Circulatory Support: Adjustment and Quality of Life (MCS A-QOL).
Sponsor / Funder: National Institutes of Health (NIH)
https://clinicaltrials.gov/ct2/show/NCT03044535

Title: Tremolo 
Principal Investigator: Liviu Klein, MD
Purpose: This is an observational study to explore how various noninvasive, wearable sensor data behaves as the human heart beats, both in healthy subjects and in patients with heart failure. The data from these sensors/devices will be recorded and analyzed for correlations to the cardiac cycle.
Sponsor / Funder: National Institutes of Health (NIH) 

Title: Relieve-HF 
Principal Investigator: Liviu Klein, MD
Purpose: The is a prospective, multi-center, randomized, double-blinded device study using the V-Wave Interatrial Shunt System. This permanent implant transfers blood from the left to the right atrium and is intended to reduce excessive left-sided cardiac filling pressures in patients with advanced heart failure (HF). The anticipated outcomes are a reduction in symptoms related to pulmonary congestion including breathlessness, improved exercise capacity, and reduced need for hospitalization or emergency treatment for acute decompensated heart failure (ADHF).
Sponsor / Funder: V-Wave, Ltd.
https://clinicaltrials.gov/ct2/show/NCT02511912

Title: Acoustic 
Principal Investigator: Liviu Klein, MD
Purpose: The purpose of this study is to identify acoustic patterns associated with normal device function in currently available continuous flow LVADS, as well as acoustic patterns associated with echocardiographic measures of heart function. Analysis of the harmonic frequency can be used to identify specific acoustic signals associated with the presence of subclinical LVAD pump thrombosis
Sponsor / Funder: UCSF

Title: CardioMEMS HF System- Post Approval Study
Principal Investigator: Van Selby, MD
Purpose: The purpose of this multicenter post approval study is to evaluate the use of the CardioMEMS HF System in patients with class II heart failure in a commercial setting.
Sponsor / Funder: St. Jude Medical (Abbott) 
https://www.clinicaltrials.gov/ct2/show/NCT02279888

Title: INVESTED
Principal Investigator: Van Selby, MD
Purpose: This is a multi-center, randomized, double-blind, active-controlled clinical trial that is aimed to demonstrate that a higher dose of influenza vaccine is superior to standard influenza vaccine in reducing the risk of all-cause death or cardiopulmonary hospitalization among high-risk cardiovascular patients.  
Sponsor / Funder: National Institutes of Health (NIH) 
https://www.clinicaltrials.gov/ct2/show/NCT02787044