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 Medicine Central DuPage Hospital, Northwestern Medicine Delnor Hospital, and Northwestern Medicine Kishwaukee Hospital, call the BCVI Research Office at 630.938.3653. TTY 711. Please visit the Bluhm Cardiovascular Institute at Northwestern Memorial Hospital for additional studies.
  • Bluhm Cardiovascular Institute at Northwestern Memorial Hospital, send an email or call 312.926.4000.

Current Clinical Trials

Condition being studied: Atherosclerotic Cardiovascular Disease
VICTORION-INITIATE: A randomized, multicenter, open-label trial comparing the effectiveness of an "inclisiran first" implementation strategy to usual care on LDL cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease and elevated LDL-C (≥70 mg/dL) despite receiving maximally tolerated statin therapy.
General Inclusion Criteria:

  • Age ≥18 years of age
  • History of Atherosclerotic Cardiovascular Disease (ASCVD):
    • Coronary heart disease (CHD),
    • Cerebrovascular disease, or
    • Peripheral arterial disease (PAD)
  • Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL
  • On maximally tolerated statin therapy.

Summary: The purpose of this study is to assess the effectiveness of an "inclisiran first" implementation strategy (addition of inclisiran to maximally tolerated statin therapy immediately upon failure to achieve acceptable LDL-C with maximally tolerated statin therapy alone) compared to usual care in patients with ASCVD.
Study website: https://clinicaltrials.gov/ct2/show/NCT04929249
Site Principal Investigator: Dr. Robert Nierzwicki
Contact Information: Julie.Petersen@nm.org

 

Condition being studied: Heart Failure with Preserved Ejection Fraction (HFpEF)
PARAGLIDE-HF: A multicenter, randomized, double-blind, double-dummy, parallel group, active controlled study to evaluate the effect of sacubitril/valsartan (LCZ696) versus valsartan on changes in NT-proBNP and outcomes, safety, and tolerability in HFpEF patients with acute decompensated heart failure (ADHF) who have been stabilized during hospitalization and initiated in-hospital or within 30 days post-discharge (PARAGLIDE-HF)
General Inclusion Criteria:

  • Age ≥ 40 years
  • Hospitalized for or within 30 days following discharge of an acute decompensated HFpEF admission
  • HFpEF with most recent left ventricular ejection fraction > 40%
  • Elevated NT-proBNP or BNP during study screening.

Summary: This study is being conducted to assess the effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP and outcomes, safety, and tolerability in patients with HFpEF who have been stabilized during hospitalization for acute decompensated heart failure and initiated in-hospital or within 30 days post-discharge.
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: 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

 

Condition Being Studied: Sweat biomarkers in cardiovascular conditions
BASIC Study: Blood And Sweat chemistry In Cardiology: Correlating biofluid chemistry during rest and stress

General Inclusion Criteria:

  • Age ≥ 18 years
  • Volunteers willing and able to complete a sauna

Summary:An exploratory study using wearable patches that collect sweat which will be used to detect the composition of sweat proteins and metabolites emitted from the skin. These proteins and metabolites from the skin will be compared to serum and urine chemistry obtained when the body is at rest and at stress.
Site Principal Investigator: Dr. Jay Pandit
Contact InformationJulie.Petersen@nm.org

 

Condition Being Studied: Heart Failure with Reduced Ejection Fraction (HFrEF)
DAPA ACT HF-TIMI 68: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial to Evaluate the Effect of In-Hospital Initiation of Dapagliflozin on Clinical Outcomes in Patients with Heart Failure with Reduced Ejection Fraction Who Have Been Stabilized During Hospitalization for Acute Heart Failure

General Inclusion Criteria:

  • Age ≥ 18 years
  • Currently hospitalized with symptoms of acute heart failure
  • Most recent left ventricular ejection fraction ≤ 40%
  • Elevated NT-proBNP or BNP during study screening.

Summary: This study is being conducted to assess the effect of in-hospital initiation of dapagliflozin, as compared with placebo, on the clinical outcomes of cardiovascular death or worsening heart failure in patients with HFrEF who have been stabilized during hospitalization for acute heart failure.
Study website: https://clinicaltrials.gov/ct2/show/NCT04363697
Site Principal Investigator: Dr. Anjan Tibrewala
Contact InformationJulie.Petersen@nm.org