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
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|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|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|
- prognosis [ Time Frame: 5 years ]5-year prognosis for patients with malignant hypertension
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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|
- 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
- Age < 18 years old
- Patients who cannot freely give their consent, or patients who refuse to participate
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
|Responsible Party:||Romain Boulestreau, Principal Investigator, Centre Hospitalier de PAU|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|