Understanding Primary Aldosteronism in Patients with Resistant Hypertension

Prospective Cross-sectional Study on Prevalence of Primary Aldosteronism in Resistant Hypertension and Association With Cardiometabolic Complications

This study is trying to find out how common primary aldosteronism is in people with high blood pressure that doesn't respond to treatment and how it might affect their heart and overall health.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Turin, Italy (Academic / other)
• Locations: 1 site (Torino, Piemonte)
• Trial ID: NCT04213963 on ClinicalTrials.gov

What this trial studies

This observational study aims to determine the prevalence of primary aldosteronism (PA) in patients suffering from resistant hypertension (RH), a condition where blood pressure remains uncontrolled despite treatment with multiple medications. The study will prospectively assess the association between PA and cardiometabolic complications in this patient population. By addressing the variability in previous studies regarding PA prevalence and its impact on cardiovascular health, this research seeks to provide clearer insights into the role of aldosterone in hypertension-related complications.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 who have been diagnosed with resistant hypertension.

Not a fit: Patients with pseudo-resistant hypertension or those with other specific causes of secondary hypertension may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and management of resistant hypertension, potentially reducing cardiovascular risks associated with primary aldosteronism.

How similar studies have performed: While there have been studies on primary aldosteronism, this prospective approach focusing specifically on resistant hypertension is relatively novel.

Eligibility criteria

Inclusion Criteria:

* age over 18 and under 80 years old;
* diagnosis of resistant hypertension defined as: uncontrolled blood pressure at ambulatory blood pressure measurement (ABPM), despite the use of at least 3 antihypertensive drugs at full dose, including a diuretic.

Exclusion Criteria:

* age under 18 or over 80 years old;
* pseudo-resistant hypertension (poor medication adherence, high salt intake);
* previous cardiovascular disease;
* insulin treated diabetes mellitus;
* other than primary aldosteronism cause of secondary hypertension (obstructive sleep apnea, renal artery stenosis, pheochromocytoma/paraganglioma, primary hyperparathyroidism, autonomous cortisol secretion or over hypercortisolism);
* liver cirrhosis;
* chronic heart failure;
* known malignant neoplasm;
* chronic disease with major organ involvement;
* excessive alcohol ingestion;
* current steroids assumption;
* use of sympathomimetic drugs;
* use of contraceptives.

Where this trial is running

Torino, Piemonte

• Division of Endocrinology, Diabetology and Metabolism; University of Turin — Torino, Piemonte, Italy (Recruiting)

Study contacts

• Principal investigator: Mauro M Maccario, MD — Endocrinology, Diabetology and Metabolism; University of Turin
• Study coordinator: Mauro M Maccario, MD

Conditions Resistant Hypertension; Primary Aldosteronism; Refractory Hypertension; Hypertensive End-Organ Damage; Atrial Fibrillation; Aortic Ectasia; Renin-Angiotensin System; Blood Pressure