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A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort (HAMA)

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ClinicalTrials.gov Identifier: NCT03755726
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : August 31, 2022
Sponsor:
Information provided by (Responsible Party):
Romain Boulestreau, Centre Hospitalier de PAU

Study Description
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Brief Summary:
This registry aims to provide the first prospective, multicentric database of patients with malignant hypertension. It will allow to assess modern epidemiology of the disease, diversity of current management and care pathway, to deepen our pathophysiological knowledges, to modernize the definition of this form of hypertension and its diagnostic criteria. The network that will emerge will finally lead to the opportunity of setting up therapeutic trials and establishing recommendations based on solid scientific evidence.

Condition or disease
Malignant Hypertension

Detailed Description:

Malignant hypertension is the most severe form of high blood pressure, fatal if left untreated. It has not disappeared, with an increasing incidence. Patients with the disease, mainly young (35 to 55 years of age), have an unfavorable cardiovascular prognosis (14% of cardiovascular and renal events at 4 years). Despite these facts, scientific research on the subject remains limited. The definitions and diagnostic criteria have not changed since 1929, and the therapeutic recommendations remain empirical.

This first prospective and multicentric registry will increase and modernize the knowledge of the disease. From these data, diagnostic and therapeutic recommendations based on solid scientific evidence could be developed.

The investigators want to first recruit 500 patients and define their prognosis at 5 years. The impact of the patient's phenotype, type and number of target organs affected will be studied.

A modern definition, adapted to these results, could be proposed. The epidemiology of the disease, the care pathways, the target organ disorders and the management carried out in the centers will be described in detail.

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : September 20, 2029
Estimated Study Completion Date : September 20, 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. prognosis [ Time Frame: 5 years ]
    5-year prognosis for patients with malignant hypertension


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with malignant hypertension
Criteria

Inclusion Criteria:

  • Malignant hypertension according to the classic definition (Severe hypertension, above 180/110 associated with severe hypertensive retinopathy)
  • Severe hypertension (above 180/110) associated with acute damage of 3 target organ due to high blood pressure

Exclusion Criteria:

  • Age < 18 years old
  • Patients who cannot freely give their consent, or patients who refuse to participate
  • Dialysis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755726


Locations
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Sponsors and Collaborators
Centre Hospitalier de PAU
More Information
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Responsible Party: Romain Boulestreau, Principal Investigator, Centre Hospitalier de PAU
ClinicalTrials.gov Identifier: NCT03755726    
Other Study ID Numbers: CHPAU2018/01
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Hypertension, Malignant
Vascular Diseases
Cardiovascular Diseases