Description: Subjects with chronic heart failure, who are not responding adequately or are resistant to current medical treatment as evidenced by persistent or worsening congestion despite a daily dose of 80mg furosemide or greater or the equivalent dose of another loop diuretic.
PI: Tamas Alexy (alexy001@umn.edu) , CRC: Gretchen Peichel (gpeichel@umn.edu)
Description: Older patients with acute decompensated heart failure (ADHF) with preserved ejection fraction (HFpEF) beginning early during hospitalization and continuing for 12 weeks in a structured outpatient setting, and continuing as a maintenance program will reduce the rate of combined all-cause rehospitalization and death at 6 months (the primary outcome), and reduce major mobility disability (MMD) prevalence at 6 months (the secondary outcome).
PI: Tamas Alexy (alexy001@umn.edu), CRC: Melanie Farinella (crawl027@umn.edu)
Description: Clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in patients enrolled with NYHA Class II Heart Failure.
PI: Tamas Alexy (alexy001@umn.edu), CRC: Michelle Pitt (henni032@umn.edu)
Description: This study will enroll Heart failure (HF) patients to evaluate the safety of the Sensor following implantation in the IVC and to assess the performance of the implanted Sensor to provide a signal to the External System for processing and display by the Web System and Mobile Application.
PI: Tamas Alexy (alexy001@umn.edu) , CRC: Gretchen Peichel (gpeichel@umn.edu)
Description: To demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care on the composite endpoint of heart failure (HF) events (hospitalization for HF or urgent HF visits) or death from cardiovascular (CV) disease in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) and a body mass index (BMI) ≥ 30 kg/m2.
PI: Tamas Alexy (alexy001@umn.edu) , CRC: Julie Choate (choat031@umn.edu)
Description: To evaluate the performance of liver stiffness measurement (LSM) in adult patients with suspected or diagnosed acute or chronic heart failure (HF) by vibration-controlled transient elastography (VCTE™) using a threshold of 13.3 kPa for the diagnosis of elevated CVP (CVP >10 mm Hg).
PI: Tamas Alexy (alexy001@umn.edu) , CRC: Julie Choate (choat031@umn.edu)
Description: The study will enroll women newly diagnosed with peripartum cardiomyopathy within 5 months postpartum in a randomized trial of bromocriptine therapy to evaluate its impact on myocardial recovery.
PI: Bhavadharini Ramu (bramu@umn.edu), CRC: Melanie Farinella (crawl027@umn.edu)
Description: The purpose of this placebo-controlled, double-blinded, randomized pilot study is to investigate the effect of empagliflozin on left atrial (LA) function in patients who are at risk for heart failure.
PI: Jeremy Van't Hof (vanth008@umn.edu), CRC: Michelle Pitt (henni032@umn.edu)
Description: We aim to better quantify the improvements in heart failure symptoms and exercise tolerance before and after the heart rate elevation in a cohort of 10 CA patients with preexisting pacemakers.
PIs: Markus Meyer (meye3249@umn.edu) & Valmiki Maharaj (maha0104@umn.du) , CRC: Julie Choate (choat031@umn.edu)
Description: The objective of this study is to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure with reduced ejection fraction (HFrEF).
PI: Gregory Helmer (helme110@umn.edu), CRC: Melanie Farinella (crawl027@umn.edu)
REACT-AF: The Rhythm Evaluation for AntiCoagulaTion with Continuous Monitoring of Atrial Fibrillation
Description: A trial comparing the current SOC of continuous DOAC use versus time-delimited (1 month) DOAC guided by an AFSW in participants with a history of non-permanent AFAF and low-to-moderate stroke risk (CHA2DS2-VASc score 1-4 for men, 2-4 for women).
PI: Lin Yee Chen (chenx484@umn.edu), CRC: Maddy Chopp (chopp015@umn.edu)
Description: Cardiac sarcoidosis patient registry.
PI: Henri Roukoz (rouko001@umn.edu), CRC: Maddy Chopp (chopp015@umn.edu)
Description: Assess the safety of dual chamber physiological pacing therapy in people with HFpEF.
PI: Tamas Alexy (alexy001@umn.edu), CRC: Julie Choate (choat031@umn.edu)
Description: To identify device failures, adverse events or adverse event trends, To characterize patient outcomes, To characterize patterns of product use, To characterize predictors of performance and effectiveness, To identify potential signals for emerging performance issues.
PI: Henri Roukoz (rouko001@umn.edu), CRCs: Michelle Pitt (henni032@umn.edu), Melanie Farinella (crawl027@umn.edu), Maddy Chopp (chopp015@umn.edu)
Description: Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR System in patients with moderate-to-severe or severe symptomatic mitral regurgitation who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.
PI: Gregory Helmer (helme110@umn.edu), CRC: Melanie Farinella (crawl027@umn.edu)
Description: Study CTQJ230A12203 is a phase II clinical trial which aims to evaluate if treatment with pelacarsen (TQJ230) versus placebo slows the progression of mild or moderate calcific aortic valve stenosis, and to further characterize the safety profile of the drug.
PI: Daniel Duprez (dupre007@umn.edu), CRC: Michelle Pitt (henni032@umn.edu)
Description: To evaluate the effect of olpasiran, compared to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants at risk for a first major cardiovascular event with elevated lipoprotein(a) (Lp[a]).
PI: Daniel Duprez (dupre007@umn.edu), CRC: Michelle Pitt (henni032@umn.edu)
Description: To evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established CVD who have completed the parent Lp(a)HORIZON study.
PI: Daniel Duprez (dupre007@umn.edu), CRC: Michelle Pitt (henni032@umn.edu)
Description: To demonstrate the long-term safety of plozasiran in subjects with HTG and SHTG.
PI: Daniel Duprez (dupre007@umn.edu), CRC: Michelle Pitt (henni032@umn.edu)
Description: The Aria CV PH System is intended to improve pulmonary arterial compliance in subjects suffering from pulmonary hypertension and right heart dysfunction.
PI: Thenappan Thenappan (tthenapp@umn.edu). CRC: Gretchen Piechel (gpeichel@umn.edu)
Description: This pilot clinical trial will evaluate the initial safety, feasibility, and pharmacokinetics of microbiota transplant therapy (MTT) with antibiotic pre-conditioning and fiber supplementation vs. placebo in patients with pulmonary arterial hypertension (PAH).
PI: Thenappan Thenappan (tthenapp@umn.edu). CRC: Gretchen Piechel (gpeichel@umn.edu)
Description: To evaluate the safety and tolerability of LIQ861 in subjects with WHO Group 1 & 3 Pulmonary Hypertension (PH).
PI: Thenappan Thenappan (tthenapp@umn.edu). CRC: Gretchen Piechel (gpeichel@umn.edu)
Description: To evaluate the effect of TX000045 vs placebo on mean PVR in participants with baseline PVR ≥3 Wood units.
PI: Thenappan Thenappan (tthenapp@umn.edu). CRC: Gretchen Piechel (gpeichel@umn.edu)
Physiology of Unloading VA ECMO Trial
Description: We aim to enroll patients admitted for acute cardiogenic shock (CS). We will include both sexes (male and female) in this study. We will include patients age ≥18 years. After enrollment, we will randomize patients in a 1:1 ratio to either receive an IABP versus remain on VA ECMO without IABP. IABP is to remain in place for 5 days. Patients must be randomized within 24 (±24) hours of enrollment. Patients will be maintained in the assigned treatment group for at least 5 days after randomization. Clinicians may crossover patients if clinically necessary—which we will analyze with both per protocol and intention to treat. Patients with IABP/pVAD prior to randomization, but then randomized to no unloading, will have the IABP/pVAD removed.
PI: Tamas Alexy (alexy001@umn.edu), CRC: Gretchen Peichel (gpeichel@umn.edu)
Description: The goal of this research project is to characterize the hemodynamic profiles that emerge in patients supported with VA ECMO with SCAI D/E cardiogenic shock due to angiographically documented acute coronary syndrome.
PI: Demetris Yannopoulos (yanno001@umn.edu), CRC-RN: Gretchen Peichel (gpeichel@umn.edu)