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

NCT04190420 | Unknown

• 1 other identifier: 2019-00898
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Heart Failure; Hypertensive Heart Disease; Diastolic Dysfunction

Keywords

Hypertension; Hypertensive heart disease; Heart failure; Biomarkers; Diastolic dysfunction

Outcome Measures

Primary Outcomes (1)

• Overall Aim

  if change in diastolic cardiac function E/e' or left atrial volume index (LAVI) after one year is associated to blood pressure at baseline.

  one year

Study Arms (2)

Patients

250 patients with primary hypertension

Healthy Controls

60 healthy control subjects, matched in age and gender

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Mattias Ekström

Stockholm, 18288, Sweden

Location

Related Publications (20)

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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.

MeSH Terms

Conditions

Hypertension; Heart Failure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Study Officials

• Mattias Ekström, Dr

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: October 1, 2018
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)