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 In-hospital Initiation of LCZ696 Compared to Valsartan in HFpEF Patients With Acute Decompensated Heart Failure (ADHF) Who Have Been Stabilized During Hospitalization (PARAGLIDE-HF)
Recruitment paused due to COVID-19
Principal Investigator: Mohammad Ali Danish Rizvi, MD
Study Sponsor: Novartis Pharmaceuticals
Location: Regions Heart Center
Phase of Study: Phase 3
Purpose of study: 8-week study to evaluate the effect of Sacubitril/Valsartan (LCZ696) versus Valsartan on changes in NT-proBNP and safety and tolerability of in hospital initiation of LCZ696 compared to Valsartan in HFpEF patients with acute decompensated heart failure stabilized during hospitalization.
Inclusion Criteria:
Currently hospitalized with acute decompensated HFpEF. Patients with a diagnosis of acute heart failure had to have symptoms and signs of fluid overload (i.e. jugular venous distention, edema or rales on auscultation or pulmonary congestion on chest x-ray). Eligible patients will be randomized no earlier than 36 hours and up to ten days after diagnosis of acute decompensation while still hospitalized as long as they meet the following definition of hemodynamic stability:
1. SBP ≥100 mm Hg for the preceding 6 hours prior to randomization; no symptomatic hypotension
-No increase (intensification) in i.v. diuretic dose within last 6 hours prior to randomization
-No i.v. inotropic drugs for 24 hours prior to randomization
-No i.v. vasodilators including nitrates within last 6 hours prior to randomization
2. HFpEF with most recent LVEF >40% (within past 3 months)
3. Elevated NT-proBNP or BNP during current hospitalization (patients not in AF: NT-proBNP ≥ 800pg/mL or BNP ≥ 250 pg/mL; patients in AF: NT- proBNP ≥ 1600pg/mL or BNP ≥ 500 pg/mL)
4. Has not taken an ACEi for 36 hours prior to randomization
Exclusion Criteria:
1. Any clinical event within the 90 days prior to randomization that could have reduced the LVEF (i.e., MI, CABG), unless an echo measurement was performed after the event confirming the LVEF to be >40%
2. Currently taking Entresto™ (sacubitril/valsartan) or any prior use
3. eGFR < 30ml/min/1.73 m2 at most recent assessment prior to randomization and within 24 hours of randomization
4. Serum potassium > 5.2 mEq/L at most recent assessment prior to randomization and within 24 hours of randomization
5. Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major CV surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, within 30 days of randomization
6. Probable alternative diagnoses that in the opinion of the investigator could account for the patient’s HF symptoms (i.e. dyspnea, fatigue) such as significant pulmonary disease (including primary pulmonary HTN), anemia or obesity. Specifically, patients with the following are excluded:
-Severe pulmonary disease including chronic obstructive pulmonary disease (COPD) (i.e. requiring home oxygen, chronic nebulizer therapy, chronic oral steroid therapy) or
-Hemoglobin (Hgb) < 10 g/dL males and < 9.5 g/dL females or
-Body mass index (BMI) > 50 kg/m2
7. Isolated right HF in the absence of left-sided structural heart disease
8. History of hypersensitivity (i.e. including angioedema), known or suspected contraindications, or intolerance to any of the study drugs including ARNIs (i.e. sacubitril/valsartan), and/or ARBs
9. Patients with a known history of angioedema due to any etiology
10. Patients with a history of heart transplant or LVAD, currently on the transplant list, or with intent to implant LVAD or CRT device within the 12 week duration of the trial
11. A cardiac or non-cardiac medical condition other than HF with an estimated life expectancy of < 3 months
12. Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloid heart disease (amyloidosis)
13. Life-threatening or uncontrolled dysrhythmia, including symptomatic or sustained ventricular tachycardia and atrial fibrillation or flutter with a resting ventricular rate >110 bpm
14. Clinically significant congenital heart disease felt to be the cause of the patient’s symptoms and signs of HF
15. Coronary or carotid artery disease or valvular heart disease likely to require surgical or percutaneous intervention within the 12 week duration of the trial
16. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
17. Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as varices
18. Participation in any other clinical trial involving investigational agents or devices within the past 30 days
19. Pregnant or nursing women; women of childbearing potential that are not using a highly effective method of contraception until 1 week following last dose
Other protocol-defined inclusion/exclusion criteria may apply
Study Contact:
Corrin Thorson
(651) 254-0757
Corrin.E.Thorson@HealthPartners.com
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 (AEGIS-II)
Recruitment paused due to COVID-19
Principal Investigator: William Nelson, MD, PhD
Study Sponsor: CSL Behring
Location: Regions Heart Center
Phase of Study: Phase 3
Purpose of study: This study is evaluating the protective effects of short-term intravenous infusions of CSL112. CSL112, also known as Apolipoprotein A-I (Human), is a novel formulation of plasma derived Apolipoprotein A-I for reduction of cardiovascular events in high-risk patients during the critical 90 days after a heart attack.
Inclusion Criteria:
-Current hospitalization for STEMI or NSTEMI (medically managed or PCI)
-AND multi-vessel coronary artery disease (at least two vessels with 50 % stenosis)
-AND on medication for diabetes mellitus OR at least two of the following risk factors (age ≥ 65 years; prior history of MI; or peripheral arterial disease)
-Documented evidence of stable renal and hepatic function
Prospective participants must be screened, enrolled, randomized and received their first infusion within five days of first medical contact.
Exclusion Criteria:
-Plan to undergo scheduled coronary artery bypass graft surgery
-Known history of allergies, hypersensitivity, or deficiencies as follows:
-Soy bean or peanut allergy
-Suspected hypersensitivity to Investigational product or placebo (albumin)
-A known history of IgA deficiency or antibodies to IgA
Other exclusions apply
Study Contact:
Corrin Thorson
(651) 254-0757
Corrin.E.Thorson@HealthPartners.com
PREEMPT-HF
Recruitment paused due to COVID-19
Principal Investigators: William Nelson MD, PhD, Dennis Zhu, MD
Study Sponsor: Boston Scientific
Location: Regions Heart Center
Phase of Study: 3
Purpose of study: The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate the HeartLogicTM Heart Failure Diagnostic (HeartLogic) in heart failure (HF) patients with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
Inclusion Criteria:
-18 years of age or older
-Documented diagnosis of HF
-Implanted Boston Scientific CRT-D or ICD device that has HeartLogic
-Active bipolar RV lead implant
-Enrolled in LATITUDE and is willing to be remotely monitored from baseline visit for approx. 12 months with HeartLogic disabled
Exclusion Criteria:
-Received or is scheduled to receive a heart transplant or ventricular assist device (VAD)
-Enrolled in any other clinical study without prior written approval from Boston Scientific (excluding registries)
-Life expectancy of less than 12 months
-History of non-compliance to medical care
Study Contact:
Corrin Thorson
(651) 254-0757
Corrin.E.Thorson@HealthPartners.com
The NODE-303 Trial – Multi-Centre, Multi-National, Open Label, Safety Study of Etripamil Nasal Spray for Patients with Paroxysmal Supraventricular Tachycardia (NODE-303 Etripamil Clinical Research in PSVT)
Principal Investigator: Marco Guerrero, MD
Study Sponsor: Milestone Pharmaceuticals Inc.
Location: Regions Heart Center
Phase of Study: Phase 3
Purpose of study: Paroxysmal Supraventricular Tachycardia (PSVT) is a disorder of the electrical conduction of the heart which is experienced as a faster-than-normal heart rate. Symptoms of PSVT include palpitations, sensations of a racing heart, dizziness, light-headedness, and shortness of breath. PSVT can be mistaken for “panic attacks.” This purpose of this study is to assess the safety and effectiveness of a new, self-administered nasal spray called Etripamil in treating PSVT outside of the hospital or clinic setting.
Inclusion Criteria:
-Has been diagnosed with PSVT by a medical professional, and reports having at least one previous episode of PSVT. For clarity, PSVT refers to episodic Supraventricular Tachycardia (SVT) that includes the atrioventricular (AV) node as a critical part of reentrant circuit.
-Is at least 18 years of age.
-Signed NODE-303 written informed consent.
-Women of child-bearing potential must be willing to use at least 1 form of contraception during the trial, and must be willing to discontinue from the study should they become or plan to become pregnant.
-Willing and able to comply with study procedures.
Exclusion Criteria:
-Patients with only a history of atrial arrhythmia that does not involve the atrioventricular (AV) node as part of the tachycardia circuit (e.g. atrial fibrillation, atrial flutter, intra-atrial tachycardia) are not eligible. Patients with a history of these tachycardias who are also diagnosed with PSVT are eligible.
-History of allergic reaction to verapamil.
-Current therapy with digoxin, or any Class I or III antiarrhythmic drug. Patients may be eligible if these drugs are stopped at least five half-lives before the administration of etripamil NS. The only exception is amiodarone which must be stopped 30 days before enrollment.
-History of ventricular pre-excitation, e.g., delta waves, Wolff- Parkinson-White syndrome.
-History of a second- or third-degree AV block.
-Symptoms of congestive heart failure New York Heart Association Class II to IV.
-Significant physical or psychiatric condition including alcoholism or drug abuse, which, in the opinion of the Investigator, could jeopardize the safety of the patient, or impede the patient’s capacity to follow the study procedures.
-History of syncope due to an arrhythmic etiology at any time, or history in last 5 years of unexplained syncope.
-Is pregnant or breastfeeding.
-Previously enrolled in a clinical trial for etripamil and received study drug.
-History of Acute Coronary Syndrome (ACS) or stroke within 6 months of screening.
-Evidence of renal dysfunction as determined by an estimated glomerular filtration rate assessed at the Screening Visit as follows:
<60mL/min/1.73m2 for patients <60 years of age;
<40mL/min/1.73m2 for patients ≥60 and <70 years of age c) <35mL/min/1.73m2 for patients ≥70 years of age.
Study Contact:
Carol Eubanks
(651) 254-4139
carol.eubanks@healthpartners.com
