Predisposition and Transition Mechanisms From Arterial Hypertension to Heart Failure

NCT02430805 | Completed DMC

• 3 other identifiers: HYPERCARE(english v. 1.0)JRPB3Cpp : 07.11.11Dgs: 2007-0537
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Hypertension

Keywords

hypertension; microinflammation and oxidative stress; renal disease; heart failure; genetics markers; genomics markers; proteomics markers

Outcome Measures

Primary Outcomes (1)

• genetic biomarkers

  time point 1 : first day ; Time point

Secondary Outcomes (4)

• oxidative stress markers

  time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years

• microinflammation markers

  time point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years

• renal function and damage markers

  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 point 1 : first day ; Time point 2 : 2 years ; Time point 3 : 4 years

Study Arms (1)

NOE

OTHER

multicentric family-based cohort. prospective and transversal study

Other: dna extraction and genotyping

Interventions

dna extraction and genotyping OTHER

blood and urine sample

NOE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Network of Excellence 6 PCRD: collaborator

Study Sites (2)

Centre D'Investigation Clinique de Strasbourg

Strasbourg, Alsace, 67000, France

Location

Hopital Brabois adulte

Nancy, Lorraine, 54000, France

Location

Related Publications (1)

• 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.

  PMID: 35004914 DERIVED

MeSH Terms

Conditions

Hypertension; Kidney Diseases; Heart Failure

Interventions

Genotype

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

• faiez ZANNAD, Pr

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: April 30, 2015
• Study Start: November 1, 2008
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 30, 2015

Record last verified: 2010-02

Locations

FR (2)