A Legacy of Scientific Contribution

Exploring new frontiers in medicine through rigorous clinical research

Key Research Focus Areas

Heart Failure Innovations

Multiple studies exploring novel treatments for both reduced and preserved ejection fraction heart failure, including the CYCLE trials, CHAMP-HF Registry, and HERMES study.

Structural Heart Disease

Groundbreaking work on valve technologies, including the Percutaneous Mitral Valve Annuloplasty trial and SPARE-MR study where Dr. Martinez-Clark served as Worldwide PI and First-in-man PI respectively.

Emerging Therapeutics

Exploration of novel molecular targets and pathways, including the Kardia-3 trial studying Zilebesiran for hypertension and various studies of innovative drug classes.

Peripheral Vascular Disease

Advanced studies of innovative treatments for peripheral artery disease, including the GREAT Trial and Pathfinder I registry of the AURYON Atherectomy Device.

Diagnostic Advancements

Evaluation of next-generation imaging and monitoring technologies, including Flurpiridaz (18F) for PET imaging and the Cordio HearO™ monitoring system.

Active Trials

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  • The ZENITH Trial is testing Zilebesiran, an RNA interference therapy targeting blood pressure reduction, in patients with persistent hypertension despite standard treatment who face elevated cardiovascular risk.

  • This Phase 3 trial evaluates whether correcting iron deficiency with IV ferric derisomaltose can reduce hospitalizations and deaths in patients with symptomatic chronic heart failure.

  • This early-phase study is testing VS-041 as a potential new therapy for heart failure with preserved ejection fraction, a common condition with few targeted treatment options.

  • The JK07 Trial is investigating a novel treatment that may improve cardiac function in chronic heart failure patients across a range of ejection fractions.


  • This study is evaluating PF-07328948, a metabolic therapy, for its potential to improve exercise capacity and reduce cardiovascular events in heart failure patients with preserved ejection fraction.

Completed Trials

  • Sponsor: General Electric
    Phase 3 study of Flurpiridaz (18F) for PET imaging in patients with suspected coronary artery disease.

  • Sponsor: Relypsa/Vifor Pharma Group
    Study of Patiromer for hyperkalemia management in heart failure patients receiving RAAS inhibitors.

  • Sponsor: Boehringer-Ingelheim
    Phase 3 trial evaluating Empagliflozin's effect on exercise ability in heart failure patients with preserved ejection fraction.

  • Sponsor: Boehringer-Ingelheim
    Phase 3 trial evaluating Empagliflozin's effect on exercise ability in heart failure patients with reduced ejection fraction.


    1. A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF) Protocol: VS-041-102 2025 (Ongoing)

       

    2. A phase III, randomized, open-label, blinded endpoint, comparative trial of ferric derisomaltose versus no intravenous iron in irondeficient subjects with symptomatic chronic heart failure Protocol: P-Monofer-CHF-02. 2025 (Ongoing)

       

    3. A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of JK07 in Adults With Chronic Heart Failure (RENEU-HF) Protocol: JK07.2.01 2025. (Ongoing)

    4. The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy [GREAT Trial] sponsor: Avantec Vascular. (Ongoing)

    5. A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Zilebesiran Used as Add-on Therapy in Adult Patients with High Cardiovascular Risk and Hypertension Not Adequately Controlled by Standard of Care Antihypertensive Medications. Sponsor: Alnylam Pharmaceuticals and Duke Clinical Research Institute. Protocol: ALN-AGT01-007 2024

    6. A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome-LIBREXIA-ACS. Sponsor: Janssen Research & Development, Protocol 70033093ACS3003 2023 (Ongoing)

       

    7. A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Effectiveness of Tovinontrine in Patients with Chronic Heart Failure with Reduced Ejection Fraction, Sponsor: Cardurion Pharmaceutical, Inc Protocol CRD-750-201. 2023

    8. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effectiveness of Tovinontrine in Patients with Chronic Heart Failure with Preserved Ejection Fraction. Sponsor: Cardurion Pharmaceutical, Inc Protocol CRD-750-202. 2023 

    9. A Phase 2, Double-Blind, Placebo-Controlled, Dose Range Finding Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of the Relaxin Agonist R2R01 combined with Standard of Care versus Standard of Care Alone in Outpatients with Worsening Heart Failure (WHF) Sponsor: River2Renal, Protocol Number: R2R01-WHF-201 2023.

    10. A Phase 3, Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation. Sponsor: Novo Nordisk Protocol: EX6018-4915 HERMES 2023

    11. A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effectiveness of CRD-740 in Subjects with Chronic Heart Failure.

    12. CARDINAL-HF Sponsor: Cardurion Pharmaceuticals, INC Protocol: CRD-740-201. 2022

    13. An International, Multicenter, Observational, Single Arm, Blinded Study to assess the performance of the Cordio HearO TM System. Sponsor: Cordio Medical Ltd. Protocol: CLN0011 2022

    14. A Descriptive, Comparative, Randomized, Crossover Study of Flurpiridaz (18F)

    15. Injection for Positron Emission Tomography (PET) Imaging for Assessment of

    16. Myocardial Perfusion Imaging Quality using High Performance Liquid Chromatography (HPLC) and Solid Phase Extraction (SPE) Manufacturing Processes.  Sponsor: General Electric Protocol: GE265-001.  2022 
       

    17. Pathfinder I: Post-Market Registry of AURYON Atherectomy Device in subjects Affected with Infranguinal Peripheral Artery Disease. Sponsor: AngioDynamics, Inc Protocol: EX-PAD-05. 2021

    18. A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831(sotrovimab) given intramusculary versus inravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high risk non hospitalized patients. Comet-Tail Sponsor: Vir Biotechnology and GlaxoSmithKline Protocol: VIR_7831-5008.  2021  

    19. Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients with Mild-Moderate COVID-19 (ARISE)-* Sponsor: Revive Therapethics, LTD Protocol: RT-003.  2020

    20. A Phase 3, Open-Label, Multicentre Study of Flurpiridaz (18F) Injection for Positron EmissionTomography (PET) Imaging for Assessment of Myocardial Perfusion in Patients Referred forInvasive Coronary Angiography Because of Suspected Coronary Artery Disease. Aurora. Sponsor: General Electric. Protocol: GE265-303. 2019-2022

    21. A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal

    22. Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND) Sponsor: Relypsa or the Vifor Pharma Group. Protocol: PAT-CR- 302.  2019-2021

    23. A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects with Acute Coronary Syndrome. Sponsor: CLS Behring Protocol #: CSL112_3001.2019 

    24. Home-Based Fluid Status Monitoring in Hearth Failure Patients Recently Hospitalized for Acute Hearth Failure. Sponsor: IMPEDIMED. 2019-2020

    25. A phase III randomised, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on Exercise ability and heart failure symptoms, in patients with CHF with preserved EF. (EMPERIAL – preserved). Sponsor: Boehringer-Ingelheim Protocol #1245-0167 2018-2019. 

    26. A phase III randomised, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on Exercise ability and heart failure symptoms, In patients with CHF with reduced EF. (EMPERIAL-reduced). Sponsor: Boehringer-Ingelheim Protocol #1245-0168 2018-2019 

    27. CHAMP-HF (Change the Management of patient with Heart Failure). Observational Registry of Treatment Patterns in US. Heart Failure Patients with Reduced Ejection fraction. Study #: CLCZ696BUS05. Sponsor: NOVARTIS.  2017- 2020 

Success Stories

Read more about our successfully completed clinical trials.

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Pioneering Procedures

Percutaneous Mitral Valve Annuloplasty

Dr. Martinez-Clark's Role: Worldwide Principal Investigator
Testing the safety and efficacy of percutaneous mitral annuloplasty using the Mitralign system in patients with functional mitral regurgitation.

SPARE-MR

Dr. Martinez-Clark's Role: First-in-man Principal Investigator
Feasibility study of spanning sutures for anterior-posterior reduction to eliminate mitral regurgitation in heart failure patients.