Luke Laffin, MD to TCTMD on the need for new and different approaches to hypertension control.

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Cardiology Pharmaceuticals

Lorundrostat’s Safe and Effective Blood Pressure Control

An aldosterone inhibitor called lorundrostat took a step towards becoming the first new antihypertensive agent class in nearly 15 years after safely and effectively treating patients with uncontrolled blood pressure in a Phase II trial.

• Mineralys Therapeutics’ lorundrostat is an aldosterone synthase inhibitor, which addresses hypertension produced by excess production of aldosterone.  

The Phase II Target-HTN dose selection trial randomized 200 participants with uncontrolled hypertension who were taking at least two antihypertensive medications.

An initial cohort of 163 patients with suppressed plasma renin (PRA ≤1.0 ng/mL/h) and elevated plasma aldosterone (≥1.0 ng/dL) were randomized to either take a placebo or five different lorundrostat regimens. After 8 weeks, lorundrostat-takers achieved notable reductions in office systolic blood pressure…

• 12.5 mg once daily: −6.9 mm Hg 
• 50 mg once daily: −13.2 mm Hg 
• 100 mg once daily: −14.1 mm Hg
• 12.5 mg twice daily: −10.1 mm Hg
• 25 mg twice daily: −13.8 mm Hg
• Placebo once daily: −4.1 mm 

A second cohort of 37 patients without suppressed plasma renin (≥1.0 ng/mL/h) were randomized in a 1:6 ratio to either take a placebo or 100 mg of lorundrostat once daily. After 8 weeks, lorundrostat-takers achieved office systolic blood pressure reductions of…

• 11.4 mm Hg, similar to the blood pressure reductions seen in the suppressed PRA cohort when taking 100 mg daily

Further analysis revealed that lorundrostat was particularly effective among obese participants and those also taking a thiazide-type diuretic.

Three serious adverse events occurred, only one of which was deemed treatment related, while potassium levels didn’t increase as much as anticipated, and decreases in renal function were similar to other drugs that affect kidney blood flow.

The authors called for more research into lorundrostat, and they won’t have to wait long as Mineralys Therapeutics is currently running another Phase II trial, and there’s a Phase III trial being planned. The authors also expect to see future research into how lorundrostat or similar aldosterone inhibitors could treat heart failure and chronic kidney disease.

The Takeaway
Lorundrostat has a lot more to prove, but these trial results suggest that it could become a valuable option in physicians’ hypertension toolbox. And given how many patients are living with uncontrolled hypertension, there’s clearly still a need for new tools to bring BP under control.

HeartFlow’s FFRCT’s Nationwide Improvements

What happens when HeartFlow’s FFRCT Analysis is adopted nationwide? See how the NHS’ nationwide implementation of HeartFlow’s FFRCT solution led to significant reductions in cardiovascular and all-cause mortality, plus solid efficiency gains.

Precision QRS Detection

QRS detection is essential for any ECG algorithm, and Monebo’s Kinetic QRS ECG Algorithm sets the standard for accuracy. Kinetic QRS accurately detects the QRS complex, no matter the amplitude, waveform, or noise levels.

The Wire

• Private Equity Cardiology’s Overuse Concerns: STAT put a spotlight on private equity-driven cardiology practice acquisitions, and this trend’s potential to drive unnecessary procedures. Attracted by rising patient demand and increased coverage of outpatient procedures, there are at least 10 private equity-funded groups in a race to buy up cardiology practices, repeating a trend seen in other specialties. Those other specialties experienced spikes in procedure volumes and healthcare costs after their PE-backed consolidations, and STAT’s sources suggest that cardiology might be heading in a similar direction.

• Duke and Us2.ai’s Echo AI Partnership: Us2.ai is partnering with Duke University to co-develop and commercialize echocardiography AI applications. The goal of the partnership is to enable earlier detection, better diagnosis, and more efficient management of patients with heart disease. Us2.ai and Duke hope to reduce interreader variability and possibly enable echo’s use as a screening tool, noting that Us2.ai’s impact on heart failure screening was recently validated in the OPERA study in Scotland.

• Cardiac Arrest Survival Disparities: A new registry study revealed racial disparities in survival rates after cardiac arrests. In the registry study using data for 764 US emergency service agencies, survival rates were significantly lower in EMS areas with primarily non-white populations (25.8% vs. 27.7%). A disproportionately higher number of the 82 EMS agencies with high Black and Hispanic populations were in the study’s lowest survival quartile (32, 39%), while few of these agencies were in the highest survival quartile (12, 14.6%). 

• DalCor’s Dalcetrapib Trial Funding: DalCor Pharmaceuticals completed an $80M Series D round that it will use to fund a Phase III trial evaluating its cholesteryl ester transfer protein inhibitor’s (dalcetrapib) ability to reduce myocardial infarction in people with the AA genotype and recent ACS. The forthcoming Dal-GenE-2 trial follows DalCor’s dal-GenE trial, which showed that dalcetrapib reduced relative MI risks by 21% globally and by 45% in North America among a genetically defined patient population.

• Incidental CAC Predicts Long-Term Risks: Stanford-led researchers applied a deep learning model to identify patients with higher CAC scores using non-ECG-gated CTs, finding that AI-based CAC scores accurately predicted long-term risk. The researchers analyzed routine chest CTs from 5,678 adults (51% women, 51% >0 CAC), finding that participants with ≥100 incidental CAC scores had a 24% 10-year risk of developing ASCVD, even though only a quarter of them were on statins. After adjustments, patients with DL-CAC ≥100 had far higher risks of death, death/MI/stroke, and death/MI/stroke/revascularization (HRs: 1.51, 1.57, 1.69).

• CT-FFR Helps Predict Risk: On a similar note, Danish researchers showed that patients with high CAC scores might be at lower risk for adverse cardiac events if they have normal HeartFlow-based FFR-CT results. In a group of 900 patients with stable angina, those with both high CAC scores (>400) and abnormal FFR-CT had a far higher rate of adverse events at three years than those with high CAC and normal FFR-CT (9% vs. 2.2%).

• LimFlow’s CLTI FDA Approval: LimFlow announced the FDA approval of its LimFlow System for the treatment of patients with chronic limb-threatening ischemia (CLTI) who have no other suitable endovascular or surgical treatment options and are facing major amputation. The LimFlow System is designed to reestablish blood flow in deep veins, and was previously found to be safe and effective in preventing amputation, achieving 99% a technical success rate and 76% limb salvage rate

• CLS Health Acquires Southeast Houston Cardiology: Houston area multispecialty group CLS Health further expanded its cardiology capabilities, acquiring local practice Southeast Houston Cardiology (6 cardiologists, 2 locations). The acquisition comes shortly after CLS Health merged with Clear Lake Cardiovascular Consultants, making cardiology CLS Health’s second largest service line after primary care.

• Does Valsartan Work in Subclinical HCM? In an analysis of 34 sarcomere mutation carriers with subclinical hypertrophic cardiomyopathy (no LVH) from the VANISH study, valsartan did not significantly slow disease progression – 18% developed overt HCM. Valsartan had previously proven effective in the original VANISH study of 178 patients with early-stage HCM. Given the new analysis’ small sample and overall modest disease progression, it can’t be concluded that valsartan doesn’t work with subclinical HCM, but it does highlight the importance of following sarcomere variant carriers longitudinally and the need to better understand HCM disease factors. 

• CorVista’s CAD Clearance: CorVista Health announced the FDA clearance of its CorVista System with CAD Add-On, which supports the diagnosis of significant coronary artery disease at the point-of-care. The CorVista System combines hardware, software, and machine learning to capture and analyze symptomatic patients’ sensor-acquired physiological signals. The CAD Add-On is the first in CorVista’s suite of cardiac detection algorithms to receive FDA clearance, which could be followed by its Pulmonary Hypertension and LV Filling Pressure algorithms.

• S4 Medical’s Esophageal Deviation Approval: S4 Medical announced the FDA De Novo Approval of its esolution esophageal deviation device, which protects Afib patients’ esophaguses during catheter ablation procedures. The approval was supported by the EASY AF study (120 patients, 12 centers), which showed that S4 Medical’s esolution reduced esophageal injuries by 84% and cut radiofrequency time by 18% without any device-related complications.

Us2.ai’s Heart Failure Screening Impact

See how Us2.ai’s echo AI solution improved heart failure screening in the NHS, reducing echo waiting times from 12 months to under 6 weeks.

The True Measure of Cardiac Risk

How can AI help physicians “see” beyond conventional lipid profiles? Tune in to this upcoming webinar, examining how Cleerly’s AI-QCT solution complements conventional approaches to evaluating heart disease risk factors, and improve coronary artery disease diagnosis and heart attack risk assessments. Reserve your spot today in order to join live on September 21st.

The Resource Wire

• Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.

• Gain in-depth knowledge of fluoroscopic anatomy and cutting-edge imaging techniques with renowned expert, Dr. Nicolo Piazza. This five-session master class is happening now through November. Register now!

• There’s plenty of short term benefits to cardiology data analytics, but it’s just as important for providers to make sure they’re ready for the future of cardiology analytics. This Change Healthcare article with Dr. Jennifer Hall, chief of data science at the American Heart Association, examines what technology leaders can do today to facilitate their future advancements in cardiovascular data and analytics.