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The Transition From Hypertension to Hypertensive Heart Disease and Heart Failure, the PREFERS Hypertension Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04190420
Recruitment Status : Enrolling by invitation
First Posted : December 9, 2019
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Mattias Ekström, Karolinska Institutet

Brief Summary:

AIMS Despite evidence-based therapeutic approaches, target blood pressure is obtained by less than half of patients with hypertension. Hypertension is associated with a significant risk for heart failure (HF), in particular HF with preserved left ventricular (LV) ejection fraction (HFpEF). Although treatment is suggested to be given early after hypertension diagnosis, there is still no evidence-based medical treatment for HFpEF. We aim to study the underlying mechanisms behind the transition from uncomplicated hypertension to hypertensive heart disease (HHD) and HFpEF. To this end, we will combine cardiac imaging techniques and measurements of circulating fibrosis markers to longitudinally monitor fibrosis development in patients with hypertension.

METHODS In a prospective cohort study, 250 patients with primary hypertension and 60 healthy controls, will be characterized at inclusion, and after 1 and 6 years. Doppler-echocardiography, cardiac magnetic resonance imaging (CMR) and ECG will be used for measures of cardiac structure and function over time. Blood biomarkers reflecting myocardial fibrosis, inflammation and endothelial dysfunction will be analysed. As a proxy for HFpEF development, the primary endpoint is to measure echocardiographic changes in LV function and structure (E/e´ and LAVI) and to relate these measures of LV filling to blood pressure, biomarkers, ECG and CMR.

CONCLUSION We aim to study the timeline and transition from uncomplicated hypertension to HHD and HFpEF. In order to identify subjects prone to develop HHD and HFpEF, we want to find biomarkers and cardiac imaging variables to explain disease progression. Ultimately, we aim at finding new pathways to prevent HFpEF.


Condition or disease
Hypertension Heart Failure Hypertensive Heart Disease Diastolic Dysfunction

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Study Type : Observational
Estimated Enrollment : 310 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Transition From Hypertension to Hypertensive Heart Disease and Heart Failure, the PREFERS Hypertension Study
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Group/Cohort
Patients
250 patients with primary hypertension
Healthy Controls
60 healthy control subjects, matched in age and gender



Primary Outcome Measures :
  1. Overall Aim [ Time Frame: one year ]
    if change in diastolic cardiac function E/e' or left atrial volume index (LAVI) after one year is associated to blood pressure at baseline.


Biospecimen Retention:   Samples With DNA
For future analysis of biomarkers and DNA extraction, aliquots of whole blood, plasma and serum will be stored in freezers (-80 degrees C) in the Stockholm Medical Biobank (Bbk2132) until analysis.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with primary hypertension will be recruited from health care centers in various socioeconomic areas in Stockholm. To include 250 patients and with an expected response rate of 25-30%, each health care center will identify and randomly select and invite 100 patients, gender 1:1. Patients will be characterized at baseline, after 1 and 6 years per standardized protocol and they will have their medication optimized at baseline and follow-ups, according to guidelines. Parallel with patient recruitment, healthy control subjects, matched in age and gender will be recruited by advertisement in local newspapers. Inclusion will be performed following a telephone interview, confirming they are apparently healthy and have no daily medication. Control subjects will follow the same study protocol as the patients but planned to be examined at inclusion only.
Criteria

Inclusion Criteria:

  • Primary hypertension
  • Age ≥ 18 years
  • Preserved cognitive function and expected longevity 1 year
  • Written informed consent

Exclusion Criteria:

  • Heart failure and/or reduced LVEF
  • Valvular heart disease of hemodynamic importance
  • Resistant hypertension
  • Pregnancy
  • Renal failure, GFR <30 mL/min/1,73 m2

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): NCT04190420


Locations
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Sweden
Mattias Ekström
Stockholm, Sweden, 18288
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Mattias Ekström, Dr Karolinska Institutet
Publications:
Lindholm L, Agenäs I, Carlbeg B, Dahlgren H, de Faire U, Hedblad B, et al. Moderately elevated blood pressure. A systematic literature review. The Swedish Council on Technology Assessment in Health Care SBU-rapport 2004;170/1-2.

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Responsible Party: Mattias Ekström, Dr, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04190420    
Other Study ID Numbers: 2019-00898
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The regional ethics committee has not approved any sharing of individual participant data. If this question comes up later we have to write a new application för ethical approval but still, all data has to be coded and pseudonymized.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mattias Ekström, Karolinska Institutet:
Hypertension
Hypertensive heart disease
Heart failure
Biomarkers
Diastolic dysfunction
Additional relevant MeSH terms:
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Hypertension
Heart Failure
Heart Diseases
Vascular Diseases
Cardiovascular Diseases