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

October 27, 2024 updated by: Gian Paolo Rossi, MD, FAHA, FACC, University Hospital Padova

High Prevalence of Secondary Arterial Hypertension (HIPRESH) with Prospective Systematic Screening

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hypertensive patients refering to our center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients with a Diagnosis of Secondary hypertension
Time Frame: From enrolment to assessment of cure/target treatment at follow up, an average of 1 year.
Conclusive diagnosis of secondary hypertension based on the availble gold standard confirmed by assessment of cure/improvement after target treatment at follow up.
From enrolment to assessment of cure/target treatment at follow up, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Padova

Investigators

  • Principal Investigator: Gian Paolo Rossi, MD, University of Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

October 27, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 27, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F 004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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