Featured Clinical Trial: Spark-PA
A new highly selective aldosterone synthase inhibitor (CIN-107) is being developed for resistant hypertension and primary aldosteronism.
Phase 1 single ascending dose clinical study established that the investigational drug is well tolerated, and demonstrated specificity for aldosterone inhibition with significant dose-dependent aldosterone lowering effect.
The investigational drug has now entered Phase 2 clinical study to determine dose selection. Volunteers are given either one of the 3 doses being tested or a placebo. Recruitment has started at one location: 2000 Crawford St, Suite 1125 in Houston, TX 77002. Additional sites will be added in the future in Birmingham, AL; Phoenix, AZ; Greenbrae, CA; San Francisco, CA; Baltimore, MD; Ann Harbor, MI; and Rochester, MN.
This is very encouraging news! Patients with primary aldosteronism are invited to participate in the clinical trial.
To qualify, patients must be:
- Adults (18 years of age or older) with a diagnosis or suspected diagnosis of PA;
- Able to wash out of protocol-specified antihypertensive medication(s) for up to 4 weeks and remain washed out for the duration of the study treatment period; and
- Willing to take allowed, protocol-specified medication(s), if needed, to maintain BP within protocol parameters.
The study’s exclusion criteria include:
- Seated SBP ≥ 180 mmHg or DBP ≥ 110 mmHg;
- BMI <40 kg/m2 and an arm circumference between 7 and 17 inches;
- Previous surgical intervention or planned surgical intervention for an adrenal adenoma or adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study;
- Documented estimated glomerular filtration rate <60 mL/min/1.73m2;
- Planned dialysis or kidney transplantation during the course of the study;
- Documented chronic heart failure;
- Stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before the Screening Visit;
- Current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease, diagnosed from a prior echocardiogram;
- Previously or planned within 6 months of the Screening Visit, coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) or any major surgical procedure during the study;
- Chronic permanent atrial fibrillation;
- On night shifts during the course of the study;
- Consumption of >14 alcoholic drinks weekly;
- Potassium <2.5 mEq/L; and,
- Potassium >5.0 mEq/L.