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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 : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Romain Boulestreau, Centre Hospitalier de PAU

Tracking Information
First Submitted Date November 26, 2018
First Posted Date November 28, 2018
Last Update Posted Date October 16, 2019
Actual Study Start Date September 20, 2019
Estimated Primary Completion Date September 20, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 26, 2018)
prognosis [ Time Frame: 5 years ]
5-year prognosis for patients with malignant hypertension
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort
Official Title A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with malignant hypertension
Condition Malignant Hypertension
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 26, 2018)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 20, 2029
Estimated Primary Completion Date September 20, 2029   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03755726
Other Study ID Numbers CHPAU2018/01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Romain Boulestreau, Centre Hospitalier de PAU
Study Sponsor Centre Hospitalier de PAU
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier de PAU
Verification Date October 2019