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The Heart Failure With Preserved Ejection Fraction (HFpEF) Pathophysiology Study.

NCT03186833 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2019-09-27

No results posted yet for this study

Summary

The study addresses the hypothesis that a gradual build-up in arterial resistance and microvascular endothelial dysfunction due to common comorbidities such as hypertension and diabetes mellitus, on top of age related vascular and cardiac changes (mainly fibrosis and hypertrophy), is responsible for HFpEF. The HFpEF syndrome is commonly seen in elderly subjects (often females) with hypertension and diabetes.

The investigators will investigate the vascular function, cardiovascular performance and myocardial fibrosis in different cohorts of subjects to try and prove this hypothesis. There will be 5 groups of subjects, all ≥ 70 years of age, as follows:

A) Normal healthy volunteers without major comorbidities including hypertension or diabetes B) Patients with hypertension only (without diabetes mellitus) C) Patients with hypertension AND diabetes mellitus D) Patients with HFpEF. E) A parallel group of patients with Heart Failure with reduced Ejection Fraction (HFrEF) group.

Arterial resistance measured by pulse wave velocity will be the primary measure and will be compared between groups A to D. A separate comparison will be made between groups D and E. Other secondary measures will focus on endothelial function (Laser Doppler measurements) and other cardiovascular performance measures (peak VO2 by CPEX, 6-minute walk distance). Bloods samples will be taken for NT-proBNP, high sensitivity Troponin T, Galectin 3 and also stored for testing later for vascular biomarkers.

Conditions

  • Heart Failure With Normal Ejection Fraction

Interventions

OTHER

no intervention

no intervention

Sponsors & Collaborators

  • University Hospitals Coventry and Warwickshire NHS Trust

    lead OTHER

Principal Investigators

  • Prithwish Banerjee, MD, FRCP · University Hospital Coventry and Warwickshire, Coventry University

  • Francesco Cappuccio, MD, MSc, DSc · University of Warwick

  • Martin Weickert, MD, FRCP · University Hospital Coventry and Warwickshire

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-06
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03186833 on ClinicalTrials.gov