HypertensionHypercareNCT02430805
Predisposition and Transition Mechanisms From Arterial Hypertension to Heart Failure
A study testing dna extraction and genotyping in people with Hypertension, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
This project aims at investigating the genetic, genomic and proteomic basis of hypertension and susceptibility to hypertension-related end organ damage (renal damage and heart failure). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- dna extraction and genotyping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2008to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- index patient :
- Caucasian patients of either sex who were diagnosed to have essential hypertension (as defined below) before the age of 50 y.
- The index patient should not be older than 60 years at the time of enrolment.
- Definition of hypertension for the index patient:
- If untreated: Systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 95 mmHg.
- If already on treatment: Treatment with more of 2 different antihypertensive drugs at the time of enrolment.
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- At least three first degree relatives of whom at least one should be affected and at least one be from a different generation (parents or offspring aged 18 years or above) must be willing to participate in the family study. For definition of hypertension in relatives of the index patient see below.
- Written informed consent
- family
- at least three other first degree relatives must be willing to participate in the family study:
- at least one first-degree relative must be affected with diagnosis of hypertension made before age of 50 years AND
- at least one first degree relative must be from a different generation (offspring or parents).
Who cannot join
- index patient :
- Any known form of secondary hypertension, including sleep apnoea syndrome
- Any known previous clinical complications of hypertension (angina, MI, stroke, TIA, peripheral artery disease) at any time
- Any known renal disease, including GFR < 60 mL/min as estimated by the abbreviated MDRD formula, or kidney stones
- Kidney or other organ transplantation
- Type 1 diabetes mellitus
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- Heart failure stage D (AHA/ACC criteria)
- Any malignant concomitant diseases or history of malignant diseases within the last five years, with exception of treated squamous skin cancer or basalioma
- Clinical or laboratory signs of acute infection, especially urinary tract infection
- Systemic inflammatory diseases, such as autoimmune diseases, connective tissue diseases or collagenoses.
- Steroids or any other immunosuppressive drug
- Severe known liver disease (ALT or gamma-GT above three-fold of upper normal limit)
- Current alcohol consume of more than 21 drinks/week (1 drink = a bottle (0,33 l) beer, a glass (0,2 l) of wine, or 4 cl = 40 ml of spirit (40%)) or drug abuse such as cocaine
- family
- any organ transplantation
- any malignant concomitant disease
- acute infection
- systemic inflammatory disease
- severe liver disease
- current alcohol or drug abuse
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Brabois adulte
Nancy, Lorraine, 54000
Centre D'Investigation Clinique de Strasbourg
Strasbourg, Alsace, 67000
About this study
Official title: Genetics and Genomics of Hypertension Associated With Microinflammation, Oxydative Stress, Chronic Renal Disease and Heart Failure (A2-B2-B3)
This project aims at investigating the genetic, genomic and proteomic basis of hypertension and susceptibility to hypertension-related end organ damage (renal damage and heart failure). It will include cross sectional as well as follow-up studies with a large number of subjects and variety of phenotypes, to explore the pathophysiology of hypertension and hypertension-related disease.
Read the detailed description
In all index patients and recruited family members, recorded data will include the following :
- Past medical history, drug history and family history
- Physical examination
- Height, weight, waist and hip circumference
- Cardiac examination
- Vascular examination
- Blood pressure
- Plasma and urine samples
- Body composition (DEXA)
- Tissue Doppler imaging
- Conditions
- Hypertension
- Being tested
- dna extraction and genotyping
- Keywords
- hypertension, microinflammation and oxidative stress, renal disease, heart failure, genetics markers, genomics markers, proteomics markers
- Medical subject headings
- Hypertension, Kidney Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dna extraction and genotypingOther
blood and urine sample
| Study group | Role | What they receive |
|---|---|---|
| NOE | Other | multicentric family-based cohort. prospective and transversal study Receives: Other: dna extraction and genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic biomarkers
Measured: time point 1 : first day ; Time point
Secondary outcomes (4)
oxidative stress markers
Measured: time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
microinflammation markers
Measured: time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
renal function and damage markers
Measured: time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
cardiac and large artery growth, remodelling dysfunction and failure markers
Measured: time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startNov 2008
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Network of Excellence 6 PCRD
- Responsible party
- Sponsor
- Investigators
- faiez ZANNAD, Pr, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430805
- Sponsor's protocol ID
- HYPERCARE(english v. 1.0)JRPB3
- Other IDs
- Cpp : 07.11.11, Dgs: 2007-0537
- Acronym
- Hypercare
- Status last verified
- Feb 2010
- First submitted
- 5 Feb 2010
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mandry D, Girerd N, Lamiral Z, Huttin O, Filippetti L, Micard E, Beaumont M, Ncho Mottoh MB, Pace N, Zannad F, Rossignol P, Marie PY. Relationship Between Left Ventricular Ejection Fraction Variation and Systemic Vascular Resistance: A Prospective Cardiovascular Magnetic Resonance Study. Front Cardiovasc Med. 2021 Dec 24;8:803567. doi: 10.3389/fcvm.2021.803567. eCollection 2021.
PubMed 35004914
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics and Genomics of Hypertension Associated With Microinflammation, Oxydative Stress, Chronic Renal Disease and Heart Failure (A2-B2-B3)
- ClinicalTrials.gov ID
- NCT02430805
- Acronym / sponsor ID
- Hypercare / HYPERCARE(english v. 1.0)JRPB3
- Conditions
- Hypertension
- Keywords
- hypertension, microinflammation and oxidative stress, renal disease, heart failure, genetics markers, genomics markers, proteomics markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Network of Excellence 6 PCRD
- Study start
- Nov 2008
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims at investigating the genetic, genomic and proteomic basis of hypertension and susceptibility to hypertension-related end organ damage (renal damage and heart failure). It will include cross sectional as well as follow-up studies with a large number of subjects and variety of phenotypes, to explore the pathophysiology of hypertension and hypertension-related disease.
Detailed description
In all index patients and recruited family members, recorded data will include the following :
- Past medical history, drug history and family history
- Physical examination
- Height, weight, waist and hip circumference
- Cardiac examination
- Vascular examination
- Blood pressure
- Plasma and urine samples
- Body composition (DEXA)
- Tissue Doppler imaging
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NOE | Other | Other: dna extraction and genotypingmulticentric family-based cohort. prospective and transversal study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- index patient :
- family
Key exclusion criteria (20 listed)
- index patient :
- family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dna extraction and genotypingblood and urine sample | Other | NOE |
Primary outcome
genetic biomarkers
Time frame: time point 1 : first day ; Time point
4 secondary outcomes
oxidative stress markers
Time frame: time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
microinflammation markers
Time frame: time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
renal function and damage markers
Time frame: time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
cardiac and large artery growth, remodelling dysfunction and failure markers
Time frame: time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Derived from this study: PubMed 35004914Mandry D, Girerd N, Lamiral Z, Huttin O, Filippetti L, Micard E, Beaumont M, Ncho Mottoh MB, Pace N, Zannad F, Rossignol P, Marie PY. Relationship Between Left Ventricular Ejection Fraction Variation and Systemic Vascular Resistance: A Prospective Cardiovascular Magnetic Resonance Study. Front Cardiovasc Med. 2021 Dec 24;8:803567. doi: 10.3389/fcvm.2021.803567. eCollection 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
faiez ZANNAD, Pr principal investigator
Central Hospital, Nancy, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dna extraction and genotyping in people with Hypertension, run by Central Hospital, Nancy, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genetic biomarkers (time frame: time point 1 : first day ; Time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02430805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.