Cardiovascular Care Clinical Trials

Cardiovascular (Heart) Clinical Trials

Cardiovascular Care Clinical Trials

If you or someone you love is living with a cardiovascular condition, clinical trials may provide a promising alternative option. The Bluhm Cardiovascular Institute at Northwestern Medicine offers access to clinical trials that look for new ways to diagnose, treat and/or prevent heart and vascular disease.

For more information regarding cardiovascular clinical trials, please visit:

  • Bluhm Cardiovascular Institute at Northwestern Memorial Hospital, send an email or call 312.926.4000‚Äč.
  • Bluhm Cardiovascular Institute at Northwestern Medicine Central DuPage Hospital, Northwestern Medicine Delnor Hospital, and Northwestern Medicine Kishwaukee Hospital, call the BCVI Research Office at 630.938.3653. TTY for the hearing impaired 630.933.4833.

Current Clinical Trials

Condition being studied: persistent or longstanding persistent atrial fibrillation
aMAZE Study: Left Atrial Appendage Ligation with the LARIATTM Suture Delivery System as Adjunctive Therapy to Pulmonary Vein Isolation for Persistent or Longstanding Persistent Atrial Fibrillation
General Inclusion Criteria:

  • Age ≥ 18 years and ≤ 80 years
  • Diagnosis of symptomatic continuous persistent or longstanding persistent non-valvular atrial fibrillation
  • Failed at least one Class I or III anti-arrhythmic drug

Summary: This study is being conducted to determine whether the LARIAT procedure can help treat patients with persistent or longstanding persistent atrial fibrillation when performed in addition to catheter ablation. The LARIAT procedure closes off the left atrial appendage non-surgically using a suture loop.
Study website: https://clinicaltrials.gov/ct2/show/NCT02513797
Site Principal Investigator: Dr. Todd Tomson
Contact Information: Julie.Petersen@nm.org

 

Condition being studied: Post-Thrombotic Syndrome
The C-TRACT Trial: Chronic Venous Thrombosis: Relief with Adjunctive Catheter-Directed Therapy
General Inclusion Criteria:

  • Age ≥ 18 years 
  • Post-thrombotic syndrome (PTS) of at least moderate severity
  • Suspicion for, or documentation of, iliac vein obstruction (complete or partial)

Summary: This study is being conducted to determine whether endovascular therapy reduces the severity of PTS and improves patient quality of life after vein damage caused by deep vein thrombosis. Patients will be randomized to either receive endovascular therapy in addition to optimal PTS care or optimal PTS care alone. Optimal PTS care includes lifestyle measures, medical therapy, compression, and venous ulcer care.
Study website: https://clinicaltrials.gov/ct2/show/NCT03250247
Site Principal Investigator: Dr. Joseph Schneider
Contact Information: Julie.Petersen@nm.org

 

Condition being studied: Acute Decompensated Heart Failure (inpatient population)
PARAGLIDE-HF: A multicenter, randomized, double-blind, double-dummy, parallel group, active controlled 8-week study to evaluate the effect of sacubitril/valsartan (LCZ696) versus valsartan on changes in NT-proBNP and safety and tolerability of inhospital initiation of LCZ696 compared to valsartan in HFpEF patients with acute decompensated heart failure (ADHF) who have been stabilized during hospitalization
General Inclusion Criteria:

  • Age ≥ 40 years
  • Hospitalized with acute decompensated heart failure with preserved ejection fraction (HFpEF)
  • HFpEF with most recent left ventricular ejection fraction > 40%
  • Elevated NT-proBNP or BNP during hospitalization

Summary: This study is being conducted to assess the effect of in-hospital initiation of sacubitril/valsartan on patient outcomes, including the proportional change in NT-proBNP from baseline, re-hospitalizations, and adverse events such as symptomatic hypotension, hyperkalemia, and angioedema.
Study website: https://clinicaltrials.gov/ct2/show/NCT03988634
Site Principal Investigator: Dr. Michelle Montpetit
Contact Information: Julie.Petersen@nm.org

 

Condition Being Studied: Valvular heart disease (VHD)
PEA-VALVE Study:  Phono- and Electrocardiogram Assisted Detection of Valvular Disease
General Inclusion Criteria

  • Patients ≥ 18 years old
  • Patients scheduled for a routine full clinical echocardiogram

Summary: This study is being conducted to collect and analyze data from the Eko DUO and the Eko CORE devices. The Eko CORE is a digital stethoscope, and the Eko DUO is a combined electronic stethoscope and electrocardiogram. These devices are being developed as a way to use artificial intelligence to detect and diagnose VHD, such as aortic stenosis and mitral regurgitation.
Study website: https://clinicaltrials.gov/ct2/show/NCT03458806
Site Principal Investigator: Dr. James Thomas; Sub-Investigator: Dr. Jay Pandit
Contact InformationJulie.Petersen@nm.org

 

Condition Being Studied: Hypertension
RADIANCE II: A study of the ReCor Medical Paradise System in Stage II Hypertension
General Inclusion Criteria:

  • Age ≥18 and ≤75 years
  • History of hypertension
  • BP ≥ 140/90 mmHg and < 180/120 mmHg
  • Currently on ≤ 2 antihypertensive medications

Summary: The purpose of this study is to assess the effectiveness and safety of the ReCor Medical Paradise renal denervation system in treating patients with Stage II Hypertension. The goal of renal denervation is to reduce blood pressure. Patients in the study will be randomized to either receive the renal denervation or a sham procedure.
Study Websitehttps://clinicaltrials.gov/ct2/show/NCT03614260
Site Principal Investigator: Dr. Keith Benzuly; Sub-Investigator: Dr. Jay Pandit
Contact InformationJulie.Petersen@nm.org

 

Condition Being Studied: Heart Failure with Preserved Ejection Fraction (HFpEF)
SPIRRIT-HFpEF: Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure with Preserved Ejection Fraction

General Inclusion Criteria:

  • Age ≥ 50 years
  • Stable heart failure
  • Most recent left ventricular ejection fraction ≥ 40%
  • Most recent NT-proBNP >300 ng/L in sinus rhythm or >750 ng/L in atrial fibrillation
    OR
    The most recent BNP >100 pg/mL in sinus rhythm or >250 pg/mL in atrial fibrillation.

Summary: The purpose of this study is to assess whether initiation of spironolactone plus standard care compared to standard care alone improves outcomes in patients with HFpEF. Patients in the study will be randomized to either receive spironolactone or not to receive the drug and remain on standard care alone.
Study Websitehttps://clinicaltrials.gov/ct2/show/NCT02901184
Site Principal Investigator: Dr. Jay Pandit
Contact InformationJulie.Petersen@nm.org

 

Condition Being Studied: Blood Pressure Monitoring
DPAT Study: Differential Pulse Arrival Time: Validation of a novel approach to continuous non-invasive blood pressure monitoring.
General Inclusion Criteria:

  • Age ≥ 18 years
  • Healthy volunteers
  • Volunteers with high blood pressure

Summary: The purpose of this study is to gather blood pressure measurements from volunteers using various methods. The data will be used to develop a novel method of blood pressure monitoring that is noninvasive and does not use the standard blood pressure cuff.
Site Principal Investigator: Dr. Sanjiv Shah; Sub-Investigator: Dr. Jay Pandit
Contact InformationJulie.Petersen@nm.org