Search Results
TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Transthyretin-Mediated Amyloidosis with Cardiomyopathy (ATTR amyloidosis with cardiomyopathy)
The purpose of this research study is to test whether nucresiran is safe and helps people with transthyretin amyloidosis (ATTR) with cardiomyopathy. In this study, the effects of nucresiran are compared to the effects of placebo. At the beginning of this study, each person will have a 2 out of 3 (67%) chance of being placed in the nucresiran group.
Jodi Carter - GeneralCardiologyResearch@hfhs.org
• Adults age 18-85 years old at the time of screening.
• Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hATTR amyloidosis with cardiomyopathy or wtATTR amyloidosis with cardiomyopathy.
• Patients may be receiving approved TTR stabilizers for ATTR amyloidosis (eg, tafamidis, acoramidis).
• Screening NT-proBNP >300ng/L; in patients with permanent or persistent atrial fibrillation, Screening NT-proBNP >600 ng/L and <8500 ng/L.
• Has known primary amyloidosis (AL amyloidosis) or leptomengeal amyloidosis
• Has a polyneuropathy disability requiring a cane or stick to walk or is wheelchair bound
• Received prior or currently receiving TTR-lowering therapy (eg, revusiran, patisiran, inotersen, eplontersen, or vutrisiran or gene therapy targeting TTR)
• Prior or anticipated (during the first 12 months after randomization) heart, liver, or other organ transplant or implantation of LVAD
• Has untreated hypo- or hyperthyroidism
• Had acute coronary syndrom or unstable angina within the past 3 months
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction (COMET-HF)
A new study called COMET-HF (sponsored by Cytokinetics, Inc.) is looking to see whether a study medicine called omecamtiv mecarbil can lower the risk for heart failure-related events and deaths, heart transplant, and strokes in people who have heart failure with a low ejection fraction (when the heart isn?t pumping out as much blood as it should with each beat).
Zack Malouf - Zmalouf1@hfhs.org
HEART Camp Connect - R01
This study aims to promote long-term adherence to exercise in adults with heart failure with preserved ejection fraction (HFpEF) by providing an exercise coach for up to one year. We will test a virtual group and in-person group against each other and against virtual enhanced usual care.
Crystal Grimshaw - cgrimsh1@hfhs.org
• diagnosis heart failure with EF >50%
• age >19 years old
• Echocardiogram within past 24 months
• chest pain
• heart attack, coronary artery bypass surgery, or pacemaker implant within past 6 weeks
• ICD (defibrillator)
ACHIEVE GREATER: Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region
ACHIEVE-P4: PATHFINDER is a study looking at the impact on symptoms and outcomes of heart failure patients utilizing portable air cleaners in their home. Participants will receive two portable air cleaners and an indoor air quality sensor. The air cleaners will be randomized to either have filters in them or not. Follow-up in-person visits are scheduled at 30- and 90-days after enrollment.
Whitney Cabral - WCABRAL1@hfhs.org
Home-based Exercise Program Using Mobile Technology After Left Ventricular Assist Device Implantation (MOVE-LVAD II)
This study is looking at whether a home-based exercise program, supported by mobile technology (such as a smartphone app, wearable device, or remote monitoring tools), can help people who have received a HeartMate 3 (HM3) LVAD become more active, stronger, and healthier after surgery.
Joshua Joven - jjoven2@hfhs.org
Using polygenic scores to guide betablocker therapy for heart failure with mildly reduced ejection fraction (UPBEAT).
Heart failure (HF) is a major public health problem that displays wide variation in progression and response to therapy. UPBEAT is a clinical trial pilot study that will use polygenic scores, a tool which describes differences in genetics, to examine effectiveness of beta blocker medication, a cornerstone of heart failure therapy. Participation requires 8 in-person visits, and randomized assignment to beta-blocker versus placebo medication.
Whitney Cabral - wcabral1@hfhs.org
A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dalcetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The DAL-302 (dal-GenE-2) trial
This research study is testing whether a medication called dalcetrapib can help lower the risk of future heart attacks in people who were recently hospitalized for acute coronary syndrome and have a certain genetic profile. The study compares dalcetrapib to a placebo to see if personalized, genetics-based treatment can better prevent serious heart problems.
Jodi Carter - GeneralCardiologyResearch@hfhs.org
• Age 45 or older
• Heart Attack within the last 90 days
• Must have AA genotype to move forward in study (we will perform the test for this at day 1
• Severe heart failure
• Severe kidney failure
• Received bypass surgery since the recent heart attack
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure (DRAIN-HF)
This study is testing whether the Aortix System is safe and works better than standard medical treatment for people who are hospitalized with acute heart failure and still have excess fluid buildup (congestion) even after receiving the usual treatments.
Kristin Clark - kclark2@hfhs.org
A randomized placebo-procedure controlled trial of the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System PULmonary artery denervation Safety and Efficacy in patients with combined pre- and post-capillary pulmonary hypertension associated with Left Heart Disease
A research study providing new treatment for pulmonary hypertension (high blood pressure in the arteries in the lungs) caused by left -sided heart disease. This study will evaluate the safety and effectiveness of investigational device called the Multi-Pole Pulmonary Artery Frequency Ablation Enhancor System ("Enhancor System").
Danielle Holmes - dholmes7@hfhs.org
• Subject is diagnosed with left sided heart failure for at least 6 months prior to being evaluated for the study and remains symptomatic despite an optimal medication regimen as prescribed by their treating physician(s).
• Patient's vital signs and internal heart pressures completed at screening and day of investigational procedure, prior to investigational implant, meet the study's inclusion requirements.
• . Subject is willing to follow all aspects of the research study, including medication compliance, follow--up visits, and testing.
• Subject has a life expectancy of less than 1 year due to non-cardiovascular causes.
• Subject has any severe heart valve disease.
• Subject has had a stroke or mini-stroke within 30 days prior to study enrollment.
• Subject refuses blood products.
• Subject has severe chronic kidney disease or on dialysis
• Subject has severe liver disease
A Phase 3, Randomized, Multicenter, Double-Blind, PlaceboControlled Study of Acoramidis for Transthyretin Amyloidosis Prevention in the Young (ACT-EARLY Trial)
ACT-EARLY is a research study to see if an investigational drug, acoramidis (AG10), is safe and effective in preventing or delaying symptoms of a disease called Transthyretin Amyloidosis (ATTR).This research study will test whether acoramidis treatment in people who do not have the disease but who carry a genetic predisposition to developing the disease is safe and effective in preventing or delaying ATTR disease (genetic predisposition is also referred to as genetic variant).
Kristin Clark - kclark2@hfhs.org
Comparative Effectiveness of Carvedilol versus Metoprolol Succinate in Heart Failure Patients with an Implantable Cardioverter Defibrillator (CARVTOP-ICD)
The purpose of this study is to compare outcomes (such as implantable cardioverter-defibrillator (ICD) treatments, hospitalization or death) in participants with heart failure who are treated with carvedilol versus metoprolol succinate
Briita Wanhala - bwanhal1@hfhs.org
• Patients 18 years of age or older
• Patients with an implantable cardioverter-difibrillator (ICD) implanted for primary prevention for Heart Failure with reduced ejection fraction with remote transmission capability
• Patients currently on treatment with metoprolol succinate and willing to switch to carvedilol
• Patients being treated with a beta-blocker (?B) other than metoprolol succinate
• Patients with a known prior intolerance or contraindication to carvedilol
• Patients with a systolic blood pressure <100 mmHg
THE MAGENTA ELEVATE HIGH-RISK PCI PIVOTAL TRIAL PROTOCOL (ELEVATE III)
For patients having a procedure to open severe blockages in the heart's arteries. Due to your severe blockages and weakened heart function, you may be at higher risk of having a drop in blood flow. THE MAGENTA ELEVATE device heart pump device is used during the procedure. This device is intended to prevent drops in blood flow during the procedure. It does this by assisting the heart in pumping blood through the body.
MICHELLE BUTCHER - MBUTCHE1@HFHS.ORG
Randomized Evaluation of Bromocriptine in Myocardial Recovery Therapy (REBIRTH) for Peripartum Cardiomyopathy
Peripartum cardiomyopathy (PPCM) is a rare type of heart failure that can happen during the last month of pregnancy or within five months after giving birth, causing the heart to weaken and not pump blood well. Many women improve with heart failure treatment. This study is testing whether bromocriptine, a drug approved in the U.S. for other conditions but not PPCM, can help improve heart function in women recently diagnosed with PPCM.
Jodi Carter - Jcarte23@hfhs.org
• New diagnosis of peripartum cardiomyopathy
• Post-delivery and within the first 5 months post-partum
• Previous diagnosis of heart disease (prior to pregnancy)