High Prevalence of Secondary Arterial Hypertension (HIPRESH) with Prospective Systematic Screening in a Cohort of Consecutive Hypertensive Patients Referring to Regional Specialized Center

NCT ID: NCT06664255

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2023-01-31

Brief Summary

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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

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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.

Conditions

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Hypertension Hypertension Resistant to Conventional Therapy Secondary Hypertension to Endocrine Disorders Secondary Hypertension Secondary Hypertension Renal Arterial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Hypertensive patients

Consecutive hypertensive patients referring to our center, and undergoing systematic diagnostic workup for secondary causes of hypertension

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Padova

OTHER

Sponsor Role lead

Responsible Party

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Gian Paolo Rossi, MD, FAHA, FACC

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gian Paolo Rossi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Padova

References

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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.

Reference Type BACKGROUND
PMID: 25631070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38748508 (View on PubMed)

Other Identifiers

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F 004

Identifier Type: -

Identifier Source: org_study_id

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