NCT06664255

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

6.1 years

First QC Date

October 22, 2024

Last Update Submit

October 27, 2024

Conditions

Keywords

Secondary HypertensionPrimary AldosteronismCausesHyperaldosteronismHypertension, RenovascularHypertension, RenalEssential HypertensionPrevalence

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with a Diagnosis of Secondary hypertension

    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.

Study Arms (1)

Hypertensive patients

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hypertensive patients refering to our center

You may qualify if:

  • age ≥18 and \>/= 85 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 25631070BACKGROUND
  • 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.

    PMID: 38748508BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum samples and 24h urine samples will be obtained by all patients. Further examination will be obtained as required by the diagnostic workup.

MeSH Terms

Conditions

HypertensionHypertension Resistant to Conventional TherapyHyperaldosteronismHypertension, RenovascularHypertension, RenalEssential Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesAdrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Gian Paolo Rossi, MD

    University of Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2024

First Posted

October 29, 2024

Study Start

January 1, 2017

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share