Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-09 @ 11:28 AM
Study NCT ID:
NCT03186833
Status:
COMPLETED
Last Update Posted:
2019-09-27
First Post:
2017-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Heart Failure With Preserved Ejection Fraction (HFpEF) Pathophysiology Study.
Sponsor:
University Hospitals Coventry and Warwickshire NHS Trust
Organization:
Study Overview
Official Title:
The Heart Failure With Preserved Ejection Fraction (HFpEF) Pathophysiology Study. Does Ageing Coupled With Vascular Effects of Comorbidities Lead to HFpEF? An In-depth Understanding From a Tertiary Centre
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDENTIFY-HF
Brief 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.
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.
Detailed Description:
The study will be a pathophysiological, single-centre, observational study, in which all 4 groups, including the parallel-group will be investigated in terms of qualitative-, echocardiographic-, arterial resistance, exercise testing (CPEX and 6-MWT), endothelial dysfunction assessment by Laser Doppler and vascular biomarker measurements. We intend to investigate if there is increasing arterial resistance from group "A" to group "D" and a significant difference in arterial resistance between groups "D" and "E" by measuring the PWV.
Primary Outcome Our primary outcome will be a difference in arterial resistance between the groups and the parallel group, as measured by aortic PWV.
Secondary Outcomes
The secondary outcomes are to assess and compare endothelial function and cardiovascular performance in all groups as measured by the following:
* Blood tests: NTproBNP, Galectin-3
* Urinalysis: Albumin, Creatinine and Metabolite profiles ("metabolomics"), related to cardiovascular risk and insulin resistance
* Transthoracic echocardiography (TTE) indices of LV diastolic function, tissue Doppler imaging and strain rate imaging
* Exercise tolerance: 6-minute walk test and a Cardiopulmonary Exercise Test (CPEX)
* Microvascular function: Laser Doppler
Primary Outcome Our primary outcome will be a difference in arterial resistance between the groups and the parallel group, as measured by aortic PWV.
Secondary Outcomes
The secondary outcomes are to assess and compare endothelial function and cardiovascular performance in all groups as measured by the following:
* Blood tests: NTproBNP, Galectin-3
* Urinalysis: Albumin, Creatinine and Metabolite profiles ("metabolomics"), related to cardiovascular risk and insulin resistance
* Transthoracic echocardiography (TTE) indices of LV diastolic function, tissue Doppler imaging and strain rate imaging
* Exercise tolerance: 6-minute walk test and a Cardiopulmonary Exercise Test (CPEX)
* Microvascular function: Laser Doppler
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: