Accessing Tomorrow's Treatments Today

Explore and apply to any of our current clinical trials below

ZENITH Zilebesiran Trial

Pedro Martinez Clark, MD

Principal Investigator

Apply to this trial

Summary

Patients with hypertension who remain inadequately controlled despite standard therapy — and who have established cardiovascular disease or are at high cardiovascular risk — remain at elevated risk for major cardiovascular events. Zilebesiran is an RNAi agent that targets angiotensinogen to reduce renin‑angiotensin system activity and lower blood pressure.

Design: ZENITH is a global, randomized, double‑blind, placebo‑controlled, event‑driven Phase 3 trial. Eligible participants on stable antihypertensive therapy are randomized to zilebesiran or placebo and followed with periodic visits; the trial continues until the prespecified number of adjudicated primary outcome events occurs (up to ~5 years).

Interventions and outcomes: Participants receive zilebesiran or placebo in addition to standard of care. The primary outcome is time to first occurrence of a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or heart failure event. Secondary outcomes include blood pressure change at Month 6 and other major CV event composites and mortality.

Inclusion Criteria

  1. Adults with established CVD disease (age ≥18) or adults at high cardiovascular risk (age ≥55)

  2. Documented coronary, cerebrovascular, or peripheral arterial disease OR clinical high cardiovascular risk

  3. Treated hypertension on stable regimen with at least two antihypertensive agents, including a thiazide/thiazide‑like or loop diuretic

  4. BP readings of SBP >=145 mmHg and <180 mmHg

Exclusion Criteria

  1. Secondary hypertension

  2. Symptomatic orthostatic hypotension

  3. Serum potassium > 4.8 mEq/L

  4. eGFR < 30

  5. Active HIV infection

  6. taking both an ARB and an ACE inhibitor ( either as single medications or part of combination medications such as ACE inhibitor/diuretic combinations or ARNis that include an ARB)

  7. Hospitalization for HF within 60 days

  8. Significant CV event ( eg, MI, stroke, revascularization procedure) within 60 days

  9. EF<40%

  10. Severe aortic stenosis.

  11. Liver cirrhosis

  12. Medical history that might limit the individual's ability participate for the duration of the study

  13. Alcohol use disorder or other substance abuse, within the last 12 months

  14. Blood pressure cannot be accurately assessed ( eg, due to cuff size limitations).

  15. Placed in an institution

Intervention Name

Zilebesiran, an investigational RNA interference (siRNA) therapeutic that reduces hepatic angiotensinogen production to lower renin‑angiotensin system activity and reduce blood pressure; compared with placebo (standard of care continued).

Trial Phase

Phase III

Duration

Event‑driven follow‑up up to approximately 5 years

Visits

At minimum: baseline visit, month 6 visit, and periodic follow‑up visits thereafter per protocol until the event‑driven study concludes (up to ~5 years). Exact visit schedule determined by study protocol.

IV derisomaltose in iron-deficient HF

Pedro Martinez Clark, MD

Principal Investigator

Apply to this trial

Summary

Background: Iron deficiency is common in people with symptomatic chronic heart failure and may worsen symptoms and outcomes. This trial tests whether correcting iron deficiency with the IV iron ferric derisomaltose reduces heart-related hospitalizations and deaths.

Design: Phase 3, randomized, open-label, blinded endpoint, multicenter trial comparing ferric derisomaltose versus no intravenous iron. Participants are randomized 1:1, followed for 52 weeks, with several in-person visits and additional phone/video contacts.

Interventions and outcomes: One group receives ferric derisomaltose plus standard of care and the other receives standard of care without IV iron. The primary outcome is the number of cardiovascular deaths and hospitalizations for worsening heart failure over 52 weeks; secondary outcomes include time-to-event endpoints, all-cause hospitalizations and deaths, rehospitalizations at 30/60 days, NYHA class changes, laboratory iron measures, and safety events.

Inclusion Criteria

  1. Age 18 years or older

  2. Symptomatic chronic heart failure (NYHA class II–IV)

  3. Left ventricular ejection fraction ≤45%

  4. Laboratory evidence of Iron deficiency

  5. On maximally tolerated guideline-directed medical therapy for heart failure

  6. proBNP II >500 pg/mL in sinus rhythm or >1,000 pg/mL in atrial fibrillation

  7. At least 1 of the following prognostic enrichment criteria:

  8. o Medical history of ischemic heart failure etiology,

  9. o eGFR ≤45

  10. o TSAT ≤15 %

  11. o Anemia as defined by a Hb of ≥9 and <12 g/dL for women and ≥9 and <13 g/dL for men

  12. Eligible irrespective of sex

Exclusion Criteria

  1. eGFR <15

  2. Chronic defined need for IV iron therapy

  3. Planned cardiac surgery, revascularization, or device implantation

  4. Pregnant or breastfeeding

  5. Received IV or IM iron within the past 6 months

  6. Receiving radiotherapy or chemotherapy

Intervention Name

Intravenous ferric derisomaltose (IV iron) to replenish iron stores and improve hemoglobin and cellular iron availability versus no intravenous iron; both arms receive standard of care.

Trial Phase

Phase III

Duration

Approximately 52 weeks (1 year) of follow-up.

Visits

4–5 in-person site visits plus 7 video/phone contacts over a 52-week follow-up period.

Phase 1HFpEF

Pedro Martinez Clark, MD

Principal Investigator

Apply to this trial

Summary

Heart failure with preserved ejection fraction (HFpEF) is a common condition with limited targeted therapies. This early phase trial evaluates the safety and biological effects of a new investigational agent in people with symptomatic HFpEF and elevated biomarker levels.

This is a randomized, parallel, Phase 1 interventional study assessing twice-daily VS-041 versus control with follow-up through Day 28 to evaluate tolerability, pharmacokinetics, and biomarker responses. Key enrollment criteria include age ≥50, NYHA II–III, LVEF ≥50%, elevated NT‑proBNP, and NordicPRO‑C6 ≥11 ng/mL.

Primary outcomes are incidence of treatment-emergent adverse events and changes in serum biomarkers (NordicPRO‑C6, endotrophin, NT‑proBNP). Secondary outcomes include PK parameters (Cmax, Tmax) for twice-daily dosing.

Inclusion Criteria

  1. Age 50 years or older

  2. HFpEF NYHA class II–III

  3. LVEF ≥50%

  4. At least one heart failure hospitalization or urgent care visit or SC diuretics

  5. Elevated NT-proBNP >125 or 250 if Afib

  6. GFR >30

  7. Stable heart failure medication regimen for ≥4 weeks

  8. Body weight ≥50 kg and BMI 18 to <45 kg/m2

Exclusion Criteria

  1. Significant cardiovascular disease other than HFpEF included valvular disease, Infiltrative cardiomyopathy,

  2. Active infection or other acute intercurrent illness

  3. ACS, MI, Stroke, TIA within 3 months

  4. Known revascularized obstructive CAD

  5. Recent acute decompensated HF (within 30 days)

  6. (ICD) implanted within 1 month

  7. Significant lung disease within past 12 months

  8. Positive Hepatitis B/C or HIV serology

  9. History of substance abuse or psychiatric/medical conditions that may impair participation

Intervention Name

VS-041 — investigational therapy administered twice daily. Intended to target pathways relevant to HFpEF and to modulate biomarkers (NordicPRO-C6, endotrophin, NT‑proBNP). Specific molecular mechanism is not specified in the registry.

Trial Phase

Phase I

Duration

28 days on-treatment follow-up (plus a prior screening period).

Visits

Approximately 4–6 visits: Screening, Baseline/randomization (Day 0), multiple on-treatment visits for safety/PK sampling through Day 28, and an end-of-study visit around Day 28.

JK07 Heart Failure Study

Pedro Martinez Clark, MD

Principal Investigator

Apply to this trial

Summary

This Phase 2 study investigates JK07, a novel treatment for chronic heart failure, focusing on safety and efficacy. Participants aged 18-85 with heart failure are randomized into two cohorts based on left ventricular ejection fraction (LVEF). Cohort 1 includes those with LVEF ≤ 40%, while Cohort 2 includes those with LVEF > 40% and ≤ 65%. The study uses a double-blind, placebo-controlled design, with participants receiving either low dose JK07, high dose JK07, or placebo. The primary outcomes include safety assessment and changes in LVEF over 52 weeks.

Inclusion Criteria

  1. NYHA Class II-III heart failure

  2. LVEF > 40% and ≤ 65% for Cohort 2

  3. Elevated NT-proBNP for Cohort 2

  4. Evidence of paroxysmal (on ≥ 2 occasions ≥ 1 week apart), persistent or permanent atrial fibrillation/flutter by electrocardiogram, Holter, implantable device, or telemetry based event monitoring within the last 5 year

Exclusion Criteria

  1. Uncontrolled hypertension

  2. Sustained low blood pressure

  3. Hypertrophic or restrictive cardiomyopathy

  4. Recent stroke, TIA or MI within 12 weeks

  5. sustained ventricular tachycardia without an implantable cardioverter-defibrillator within 12 weeks

  6. Atrial fibrillation with high ventricular rate

  7. AF ablation within 12 weeks

  8. AF or atrial flutter, not on adequate anticoagulant therapy, if contraindication: a percutaneous left atrial appendage occluder device is also acceptable within 45 days prior screening.

  9. Recent cardiac surgery or intervention

  10. Implantation of CRT device within 12 weeks

  11. Use of mechanical circulatory support

  12. Orthopedic impairment preventing 6MWT.

  13. COPD or other pulmonary disease with oxygen, chronic nebulizer therapy, chronic oral steroid therapy.

  14. GFR <30

Intervention Name

JK07, a novel therapeutic targeting heart failure, is administered in low or high doses. It works by potentially modulating pathways involving Neuregulin 1 (NRG-1) and its receptors HER3 and HER4, aiming to improve cardiac function and outcomes in patients with varying ejection fractions.

Trial Phase

Phase II

Duration

52 weeks

Visits

Participants will undergo regular assessments over a 52-week period, including baseline visits, randomization into treatment groups, and follow-up visits to monitor safety and changes in LVEF.

Heart Failure Preserved EF Study

Pedro Martinez Clark, MD

Principal Investigator

Apply to this trial

Summary

This study investigates branched-chain ketoacid dehydrogenase kinase inhibitor, for treating heart failure (HF). Participants are adults with HF, NYHA Class II-IV symptoms, and left ventricular ejection fraction over 40%. The study is randomized, double-blind, and placebo-controlled, lasting 48 weeks. Participants will take either PF-07328948 or a placebo daily. The primary outcomes include cardiovascular events and changes in exercise capacity and quality of life, while secondary outcomes focus on adverse events and additional health status measures.

Inclusion Criteria

  1. Adults aged 18 years or older

  2. Diagnosed with heart failure for at least 3 months

  3. NYHA Class II-IV symptoms

  4. Left ventricular ejection fraction > 40%

  5. BMI of 27 kg/m2 or higher

Exclusion Criteria

  1. Type 1 diabetes, liver cirrhosis, or absorption issues

  2. Scheduled major surgery affecting walking

  3. History or listing for heart transplant

  4. SGLT2 inhibitor intolerance or contraindication

Intervention Name

The study evaluates PF-07328948, a branched-chain ketoacid dehydrogenase kinase inhibitor, administered orally once daily to assess its safety and efficacy in heart failure patients.

Trial Phase

Phase II

Duration

Participant duration is 48 weeks.

Visits

Participants will visit the clinic 15 times over 48 weeks, with 5 visits possibly via phone and 10 at the study site.

Golazo® GREAT Trial

Pedro Martinez Clark, MD

Principal Investigator

Apply to this trial

Summary

This study aims to confirm the safety and effectiveness of the Golazo® Peripheral Atherectomy System in treating symptomatic infrainguinal peripheral arterial disease (PAD) in 159 subjects across up to 15 U.S. investigational sites.

Inclusion Criteria

  1. Candidate for lower limb peripheral vasculature atherectomy

  2. Meets one of the following hemodynamic criteria:

    1. Resting ankle brachial index (ABI) of 0.90 or less, or 0.75 or less after exercise

    2. Non-compressible arteries (ABI >1.1) with a toe brachial index (TBI) of 0.80 or less

  3. Rutherford clinical classification for target limb category 3 to 5

  4. Deemed suitable for angiography and endovascular intervention by the investigator

  5. Angiographic Inclusion Criteria: (To be determined in the cath lab):

    1. Target lesion(s) with stenosis of 70% or more by visual estimation

    2. Total treated lesion length of 15 cm or less by visual estimation

    3. Target reference vessel diameter between 2.0 mm and 4.5 mm by visual estimation

    4. Target lesion has at least one patent tibial vessel runoff to the foot that crosses the ankle and provides perfusion at baseline

Exclusion Criteria

  1. Active infection in the target limb

  2. Recent endovascular procedure or open vascular surgery on the target limb (<30 days)

  3. Planned surgical/interventional procedure within 30 days post-index procedure

  4. Lesion in the opposite limb needing intervention during/within 30 days of index procedure

  5. Critical limb ischemia (CLI) with Rutherford category 6

  6. Significant kidney disease (GFR <30) or on dialysis

  7. Recent acute myocardial infarction or uncontrolled comorbidity

  8. Myocardial infarction or stroke within 2 months of baseline

  9. Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy

  10. Uncorrectable bleeding disorder, platelet count <125,000/microliter, known coagulopathy, or INR >1.5

  11. Target lesion(s) within native/synthetic vessel graft

  12. Significant untreated inflow stenosis/occlusion

  13. Foot complications: osteomyelitis extending to metatarsal bones, gangrene/plantar skin ulcer of forefoot/midfoot/heel, heel ulcer, wound with calcaneal bone involvement, neuropathic/non-ischemic wounds, wounds needing flap coverage/large soft tissue defect management

  14. Congestive heart failure (NYHA III or higher)

  15. Angiographic criteria (to be determined in the cath lab):

    1. >2 lesions for investigational device treatment; lesions <3 mm apart considered single lesion

    2. Clinical/angiographic complication (other than non-flow limiting dissections) attributed to a marketed device prior

    3. In-stent restenosis within target lesion(s)

    4. Unstable/flow-limiting dissection (type C or greater)

    5. Clinical/angiographic evidence of distal embolization

    6. target lesion with severe calcification that is non imageable in angiogram.

    7. Inability to cross proximal lesion lumen with guidewire (not subintimal)

Intervention Name

The Golazo® Peripheral AS, a sterile, single-use device designed for peripheral vasculature atherectomy, comprises two primary components: the Golazo® Accustrike atherectomy catheter and the motorized drive unit (MDU). This intervention aims to enhance the treatment of peripheral arterial disease by removing plaque from blood vessels, improving blood flow.

Trial Phase

N/A

Duration

6 months

Visits

Procedure.

1 month follow up

6 month follow up