Clinical trial NCT06664255: High Prevalence of Secondary Arterial Hypertension (HIPRESH) with Prospective Systematic Screening in a Cohort of Consecutive Hypertensive Patients Referring to Regional Specialized Center
Official title: High Prevalence of Secondary Arterial Hypertension (HIPRESH) with Prospective Systematic Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Hypertension Resistant to Conventional Therapy
Secondary Hypertension to Endocrine Disorders
Secondary Hypertension
Secondary Hypertension Renal Arterial
Keywords: Secondary Hypertension
Primary Aldosteronism
Causes
Hyperaldosteronism
Hypertension, Renovascular
Hypertension, Renal
Essential Hypertension
Prevalence
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hypertensive patients refering to our center

Brief summary: Hypertensive Patients referring to our center will undergo a systematic diagnostic workup aimed at finding the cause(s) of their high blood pressure. Information prospective and retrospectively obtained will be analyzed while guaranteeing anonymity.

Detailed description: The Investigators will retrospectively enroll consecutive patients attending the outpatient clinic of the Specialized Hypertension Center at the Department of Medicine of the University of Padua from January 1 st 2017 to January 31 st 2023. The data obtained from the review of clinical chart and findings from biochemical and radiological examinations will be recorded in a secured database and will be analyzed in an anonymized and aggregated form.

Per Investigators' practice, during the first visit, patients attending our Referral Center undergo a complete clinical evaluation entailing extensive medical history and supine and standing office blood pressure measurement, ECG and are offered a screening for secondary hypertension. To this end, patients are usually switched to treatment with a long-acting calcium-channel blocker, mostly verapamil slow-release and/or doxazosin, for at least 6 weeks beforebiochemical testing.

From 2020, based on the results of the "Effects of Mineralocorticoid and AT1 Receptor Antagonism on the Aldosterone-Renin Ratio in Primary Aldosteronism" (EMIRA), 13 those with difficult-to-control hypertension and/or hypokalemia also received a mineralocorticoid receptor antagonist (MRA). As per institutional rules, at the Investigators' University Hospital all the patients are requested to sign a written consent for the processing of their data in an anonymized way for educational and research purpose. All the patients will receive exhaustive information about the need of screening for secondary hypertension, which entailed good clinical practice.

Biochemical data that will be recorded include serum Na + , K + , and ionized Ca 2+ levels, plasma active renin concentration (DRC), aldosterone concentration (PAC), used to compute the aldosterone-renin ratio (ARR), 24h urine Na + , K + , and Ca 2+ excretion, metanephrine and normetanephrine excretion in acidified urines, serum parathyroid hormone, thyroid-stimulating hormone, and free triiodothyronine and free thyroxine. The Investigators will also record data from renal Doppler ultrasonography, sleep questionnaires for sleep apnoea, sleep fragmentation, and daytime sleepiness, when performed. In patients who underwent second level imaging tests, e.g. abdomen MRI, CT or angio-CT and subtyping by adrenal vein sampling (AVS) or full poly-somnography, data from these additional tests will be registered.

Eligibility criteria: Inclusion Criteria:

* age ≥18 and \>/= 85 years

Exclusion Criteria:

* absence of a complete diagnostic work-up due to poor overall clinical conditions or lack of a clear benefit from it
* unwillingness or failure to complete the full diagnostic work-up and/or to attend the outpatient clinic follow-up visits after the first evaluation

Primary outcomes:
measure: Number of Patients with a Diagnosis of Secondary hypertension
timeFrame: From enrolment to assessment of cure/target treatment at follow up, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Padova
name: Gian Paolo Rossi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azizi M, Sapoval M, Gosse P, Monge M, Bobrie G, Delsart P, Midulla M, Mounier-Vehier C, Courand PY, Lantelme P, Denolle T, Dourmap-Collas C, Trillaud H, Pereira H, Plouin PF, Chatellier G; Renal Denervation for Hypertension (DENERHTN) investigators. Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial. Lancet. 2015 May 16;385(9981):1957-65. doi: 10.1016/S0140-6736(14)61942-5. Epub 2015 Jan 26.
citation: Rossi GP, Bagordo D, Rossi FB, Pintus G, Rossitto G, Seccia TM. 'Essential' arterial hypertension: time for a paradigm change. J Hypertens. 2024 Aug 1;42(8):1298-1304. doi: 10.1097/HJH.0000000000003767. Epub 2024 May 8.