Cardiology: Clinical Research Program

Eligibility

• Symptomatic Hypertrophic cardiomyopathy
• Any acute or serious comorbid

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT04848506

Principal Investigator

Dr. Srihari Naidu

Contact for Study Screening

[email protected]

Eligibility

• Male or female, Between 18–85 years of age at screening
• Body mass index < 40 kg/m2
• Diagnosed with nHCM and has a screening echocardiogram with the following:
  • End-diastolic LV wall thickness:
    • ≥ 15 mm in one or more myocardial segments OR
    • ≥ 13 mm in one or more wall segments and a known disease-causing gene mutation or positive family history of HCM AND
    • Resting LVOT-G < 30 mmHg AND Valsalva LVOT-G < 50 mmHg AND
    • LVEF ≥ 60%
  • Participants with a history of intracavitary obstruction are eligible.
• NYHA class II or III
• Respiratory exchange ratio of ≥ 1.00 at screening by CPET and predicted peak oxygen uptake (pVO2) of ≤ 90% for age and sex
• KCCQ-CSS score of ≥ 30 and ≤ 85
• N-terminal prohormone brain natriuretic peptide (NT-proBNP) of:
  • ≥ 300 pg/mL or ≥ 900 pg/mL if in atrial fibrillation or atrial flutter OR
  • For Black participants, ≥ 225 pg/mL or ≥ 675 pg/mL if in atrial fibrillation or atrial flutter
• Hemoglobin ≥ 10 g/dL
• Participants on beta-blockers, verapamil, diltiazem, or ranolazine should have been on stable doses for ≥ 2 weeks prior to screening CPET and anticipate remaining on the same medication regimen during the study
• Exclusion criteria:
  • Significant valvular heart disease (per Investigator judgment)
    • Moderate or severe valvular aortic stenosis or fixed subaortic obstruction
    • Moderate or severe mitral regurgitation
  • Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics nHCM (e.g., Noonan syndrome, Fabry disease, amyloidosis)
  • Known current unrevascularized coronary artery stenosis of ≥ 70% or documented history of myocardial infarction
  • History of LV systolic dysfunction (LVEF < 45%) or stress cardiomyopathy
  • Inability to exercise on a treadmill or bicycle (e.g., orthopedic limitations)
  • Documented room air oxygen saturation reading < 90% at screening or history of significant chronic obstructive pulmonary disease or severe/significant pulmonary hypertension
  • History of syncope, symptomatic ventricular arrhythmia, or sustained ventricular tachyarrhythmia with exercise within 3 months prior to screening

Enrollment Status: Enrolling

Principal Investigator

Srihari Naidu, MD

Study Information

ClinicalTrials.gov | NCT06081894

Contact for Study Screening

[email protected]

Eligibility

• Age 18 years or older
• Hospitalization for acute myocardial infarction with evidence of type 1 myocardial infarction (MI) by invasive angiography performed at site with percutaneous coronary intervention (PCI) capabilities.
  • ST-segment elevation myocardial infarction with all the following:
    • Relevant symptoms suggestive of cardiac ischaemia within 12 hours before hospitalization or during hospitalization.
    • ECG-changes (in the absence of left ventricular hypertrophy or left bundle branch block): ST-segment elevation at the J point in at least two contiguous leads ≥0.25 mV in men <40 years, ≥0.2 mV in men ≥40 years, or ≥0.15 mV in women in leads V2-V3; and/or ≥0.1 mV in all other leads.
  • Non-ST-segment myocardial infarction with all the following:
    • Relevant symptoms suggestive of cardiac ischaemia within 24 hours before hospitalization or during hospitalization.
    • Rise and/or fall in cardiac troponin I or T with at least one value above the 99th percentile upper reference limit.
  • Possibility for randomization as early as possible after invasive procedure, and latest within 36 hours of hospitalization (time 0) for STEMI, and latest within 48 hours of hospitalization (time 0) for NSTEMI.
  • Presence of at least one of the following criteria (confirmed based on the participant’s medical records and/or medical history interview):
    • Any prior MI
    • Prior coronary revascularisation
    • Diabetes mellitus treated with glucose-lowering agent(s)
    • Known CKD (eGFR ≥15 and <60 mL/min/1.73 m²)
    • Prior ischaemic stroke
    • Known carotid disease or peripheral artery disease in the lower extremities
    • Multivessel coronary artery disease (current/prior)
    • For STEMI patients only: anterior MI at index AMI
• Exclusion Criteria:
  • All exclusion criteria are based on the participants’ medical records and/or medical history interview and clinical assessments. Local laboratory test results for assessment of exclusion criteria should be based on the most recent test prior to randomization and must be as early as possible and within 36 hours of hospitalization for STEMI, and within 48 hours of hospitalization for NSTEMI.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06118281

Principal Investigator

Jain Diwakar, MD

Contact for Study Screening

[email protected]

Eligibility

• Age ≥ 18 years < 80 years
• Acute onset of symptoms ≤ 14 days consistent with the presence of pulmonary embolism.
• CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
• RV/LV ratio of > 0.9 on CTA as assessed by investigator (site determined).
• Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
• Subject or subject’s legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care Protocol-specific procedures
• Subject is willing and able to comply with all Protocol-required follow-up visits
• Exclusion Criteria:
  • Thrombolytic use within 30 days of baseline CTA
  • Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization (site determined)
  • Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
  • Unstable heart rate > 130 beats per minute prior to procedure
  • FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
  • Hematocrit < 28%
  • Platelets < 100,000/Μl
  • Serum baseline creatinine > 1.8 mg/dL
  • International normalized ratio (INR) > 3
  • Major trauma injury severity score (ISS) > 15 within the past 14 days
  • Presence of intracardiac lead in the right ventricle or right atrium placed <180 days prior to the index procedure
  • Cardiovascular or pulmonary surgery within last 30 days
  • Actively progressing cancer requiring chemotherapy
  • Known bleeding diathesis or coagulation disorder
  • Left bundle branch block
  • History of severe or chronic pulmonary arterial hypertension
  • History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
  • History of decompensated heart failure
  • Patients on extracorporeal membrane oxygenation (ECMO)
  • History of underlying lung disease that is oxygen dependent

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06576427

Principal Investigator

Hasan Ahmad, MD

Contact for Study Screening

[email protected]

Eligibility

• Male or female, Between 18–85 years of age
• Participants with New York Heart Association (NYHA) Class II-III
  • Cohort 1 – Left Ventricular Ejection Fraction (LVEF) ≤ 40%
  • Cohort 2 – Left Ventricular Ejection Fraction (LVEF) >40% and ≤ 65%, elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥ 600pg/mL and atrial fibrillation/flutter
• Stable HF defined as no hospitalizations for cardiac-related issues within 4 weeks prior to the initial screening visit or between screening and randomization, other than for routine percutaneous procedures such as device battery/generator changes or new pacemaker lead insertion
• Participants should be established on background optimal medical therapy for HF and be treated according to locally recognized guidelines with both drugs and devices, as appropriate
• Screening hemoglobin ≥ 9.0 g/dL
• Exclusion criteria:
  • Uncontrolled hypertension
  • Sustained systolic Blood Pressure (BP) < 90 mmHg and/or diastolic BP < 50 mmHg on 2 consecutive (duplicate seated) readings at screening
  • Heart failure due to hypertrophic cardiomyopathy, restrictive and/or infiltrative cardiomyopathy, arrhythmogenic right ventricular dysplasia, Fabry disease, or Noonan syndrome with LV hypertrophy or a positive serum immunofixation result
  • Diagnosis of stress-induced (Takotsubo) cardiomyopathy, myocarditis, or peripartum cardiomyopathy
  • Diagnosis of chemotherapy- or radiation-induced cardiomyopathy
  • Diagnosed with stroke or Transient Ischemic Attack (TIA) within 12 weeks of screening
  • History of syncope within the last 12 weeks prior to screening or sustained ventricular tachycardia without an implantable cardioverter-defibrillator
  • Moderate or severe aortic and/or mitral valve stenosis
  • Medically documented unstable angina, acute coronary syndrome (e.g., myocardial infarction, troponin-positive with symptoms of angina or unstable angina) within the last 8 weeks prior to start of screening
  • Medically documented ST-elevation myocardial infarction within 12 weeks of screening.
  • Any narrow complex tachycardia (inclusive of atrial fibrillation or atrial flutter) with a resting ventricular rate > 110 beats per minute at screening
  • For participants with a history of AF or atrial flutter, not on adequate anticoagulant therapy via non-vitamin K oral anticoagulants or warfarin if the CHA2DS2-VASc score is ≥ 2 in men or ≥ 3 in women or per local guidelines
  • AF ablation within the last 12 weeks prior to screening or planned during the study duration
  • Symptomatic bradycardia or second (Mobitz Type II)- or third-degree heart block without a pacemaker

Enrollment Status: Enrolling

Principal Investigator

Stephen Pan, MD

Study Information

ClinicalTrials.gov | NCT06369298

Contact for Study Screening

[email protected]

Eligibility

• Male or female, 22-85 years of age.
• Documented history of symptomatic or asymptomatic paroxysmal or persistent AF. The duration of AF must have been > 30 seconds as documented by an external monitor or present on 12-lead ECG.
• CHA2DS2-VASC score of 1-4 without prior stroke or TIA**
• The participant is on a DOAC at the time of screening.
• Inclusion/Exclusion Criteria: for matched healthy controls; Valvular or permanent atrial fibrillation, Current treatment with warfarin and unwilling or unable to take a DOAC.

Enrollment Status: Actively enrolling

Study Information

Grant # UG3HL15065

Principal Investigator

Jason Jacobson, MD

Contact for Study Screening

[email protected] or [email protected]

Eligibility

• Male or Female, Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2VASc ≥3
• Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)
• Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study
• At least 1 of the following:
  • Severe renal insufficiency (creatinine clearance <30 mL/min by the Cockcroft-Gault formula)
  • Planned daily use of aspirin, a P2Y12 inhibitor, or other antiplatelet agent for the duration of the trial
  • History of bleeding from a critical area (such as intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome) or major gastrointestinal bleeding
  • Other conditions associated with an increased risk of bleeding such as chronic NSAID use (≥3 times per week); frailty; or history of multiple falls
• Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study
• Exclusion Criteria:
  • AF due to an ongoing acute reversible cause (e.g., cardiac surgery, PE, untreated hyperthyroidism, alcohol use)
  • Patients who within 60 days prior to randomization (1) received a VKA (e.g., warfarin, phenprocoumon, acenocoumarol) or a DOAC such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF
  • Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment
  • Any stroke within 14 days before randomization or TIA within 3 days before randomization
  • Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study
  • Patients with a medical condition other than AF for which chronic anticoagulation is indicated
  • Known presence of an atrial myxoma or left ventricular thrombus
  • History of or planned LAA closure or occlusion device
  • Clinically unstable or active endocarditis or endovascular infection
  • Planned invasive procedure with potential for uncontrolled bleeding (e.g., major surgery) within the next 3 months
  • Patients on dialysis at screening or who are planned to start dialysis within 6 months.
  • Use of other investigational drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer
  • History of hypersensitivity to any of the study drugs or its excipients, to drugs of similar chemical classes
  • Women of child-bearing potential defined as all women physiologically capable of becoming pregnant
  • Any medical or psychiatric condition which in the judgment of the Investigator may preclude patients from complying with study requirements for the duration of the study
  • Any patients who are committed to an institution by either judicial or administrative authorities
  • Patients who are employed by the sponsor or employed by the investigator or otherwise financially dependent on them

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT05712200

Principal Investigator

Jason Jacobson, MD

Contact for Study Screening

[email protected]

Eligibility

• Subjects diagnosed with persistent (not longstanding) AF or recurrent AF, as defined for this study.
• Subject has a recent 12-lead electrogram data of AF (including baseline, pacing and clinical arrhythmia) recorded on the electrogram recording system (e.g., Bard, Boston-Scientific, St. Paul, MN or Prucka, GE Medical) or standalone ECG system (e.g., GE Muse, Minnesota, or CardioCard (Nasiff, NY) in digitized format.
• The following data elements can be abstracted from the patient medical records or confirmed and documented prior to the scheduled procedure (to be inputted in vMap®):
  • Atrial fibrillation type
  • Atrial characteristics: geometry (normal, left and/or right atrial enlargement), Utah classification, prior ablation modality (e.g., radiofrequency, cryoablation, pulsed field ablation), prior ablation lesion location(s).
• Subject is ≥ 22 years of age at time of enrollment/consent.
• Subject is indicated to undergo an ablation procedure at the medical discretion of the Investigator.
• Subject is able and willing to comply with the protocol requirements, has been informed of the nature of the study.
• Exclusion Criteria:
  • Subjects with arrhythmias other than persistent or recurring AF as defined for this study, including long-standing persistent atrial fibrillation (persistent AF lasting ≥ 1 year from diagnosis).
  • Inability to obtain ECG prior to or during the clinical ablation procedure; or unacceptable ECG data quality such as low ECG signal-to-noise ratio or lack of ECG data in one or more leads.
  • Subjects who are participating in another clinical investigation with an investigational drug or device at the time of enrollment or planned participation at any time during this clinical investigation.
  • Subjects who have a known or suspected medical condition that, in the opinion of the Investigator, may put the subject at risk for participation in this clinical investigation.
  • Subjects who are pregnant as confirmed by the institution’s standard pre-surgery practice.

Enrollment Status: Actively enrolling

Study Information

ClinicalTrials.gov | NCT06935591

Principal Investigator

Sei Iwai, MD

Contact for Study Screening

[email protected]

Eligibility

• Males or females age >18
• Presence of BIV pacemaker or defibrillator
• Exclusion Criteria:
  • Unable or unwilling to provide consent
  • Non-English-speaking patients

Enrollment Status: Actively enrolling

Principal Investigator

Jason Jacobson, MD

Contact for Study Screening

[email protected]

Eligibility

• Men and women 18 and 75 years of age (inclusive) at the time of signing the ICF.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• Documented diagnosis of WHO PAH Group 1 in any of the following subtypes:
  • Idiopathic PAH
  • Heritable PAH
  • Drug/toxin-induced PAH
  • PAH associated with CTD
  • PAH associated with simple, congenital systemic-to-pulmonary shunts ≥1 year following repair
• Must have a BMI of ≥18.5 kg/m2 and ≤35.0 kg/m2 during screening.
• Baseline RHC performed during the screening period documenting a PVR of ≥400 dyn·sec·cm-5, a PCWP or left ventricular end-diastolic pressure of ≤15 mmHg, and an mPAP of >20 mmHg. If the population mean baseline PVR falls below 700 dyn·sec·cm-5, enrollment may be restricted to participants with a baseline PVR of ≥600 dyn·sec·cm-5 for the remainder of the study.
• On stable doses of background PAH therapy (≤3 PAH specific medications) including endothelin receptor antagonists, phosphodiesterase-5 inhibitors, prostacyclins, and soluble guanylate cyclase stimulators for ≥90 days before screening. Current use of sotatercept is not permitted in this study.
• Anticipated to be able to perform the 6MWT according to American Thoracic Society Guidelines for the duration of the study.
• 6MWD ≥100 and ≤475 m repeated twice at screening (measured at least 4 hours but no longer than 1 week apart), with both values within 15% of each other (calculated from the highest value).
• NT-proBNP >300 ng/L during screening.
• If female and a WOCBP as defined in Section 7.2.1, must meet all the requirements below:
  • Agrees to use a contraceptive method that is highly effective (defined as having a failure rate of <1% per year as described in Section 7.2.2) from 30 days before dosing through 14 days after the last dose of study drug AND
  • Agrees not to donate eggs (ova, oocytes) for the purpose of reproduction from at least 14 days prior to dosing through the end of the study AND
  • Has negative pregnancy tests at screening and before the administration of the first dose of study drug
• Exclusion Criteria:
  • Diagnosis of PAH WHO Groups 2, 3, 4, or 5.
  • Diagnosis of the following PAH Group 1 subtypes:
    • HIV-associated PAH
    • PAH associated with portal hypertension
    • Schistosomiasis-associated PAH
    • Pulmonary veno-occlusive disease
  • Diagnosis or history of any of the following substance-related conditions:
    • Methamphetamine-associated PAH
    • History of cocaine or methamphetamine (amphetamine-type stimulant) use within 24 months prior to screening defined by self-report, medical history, or positive drug screen in medical records
    • Any diagnosis of cocaine or methamphetamine use disorder (per medical record or self-report) within 24 months prior to screening
  • Uncontrolled diabetes mellitus, defined as HbA1c ≥9.0%.
  • Any of the following BP-related values or abnormalities:
    • Uncontrolled systemic hypertension as evidenced by sitting systolic BP >160 mmHg or sitting diastolic BP >100 mmHg at screening after 5 minutes of rest
    • Baseline systolic BP <90 mmHg at screening
    • Syncope within 3 months before screening
  • History of restrictive, constrictive, or congestive cardiomyopathy.
  • ECG with QTcF ≥450 msec in males or ≥470 msec in females at screening or ≥500 msec in the presence of a right bundle branch block.
  • Personal or family history of long QT syndrome or sudden cardiac death.
  • Presence of a CardioMEMS device or any other implanted hemodynamic monitoring device.
  • FVC <70% on PFT performed no more than 6 months before screening; or if FVC is 60% to 69%, must have a chest computed tomography scan within 12 months with no more than mild interstitial lung disease.
  • Evidence of LVEF <45% (by Simpson’s biplane method) or evidence of impaired relaxation on screening echocardiogram by E/e’ >13.
  • History of atrial fibrillation or atrial flutter.

Enrollment Status: Enrolling

Study Information

ClinicalTrials.gov | NCT07365332

Principal Investigator

Erika Berman-Rosenzweig, MD

Contact for Study Screening

[email protected]