Heart Failure With Normal Ejection Fraction Clinical Trial
— IDENTIFY-HFOfficial 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
NCT number | NCT03186833 |
Other study ID # | PB186316 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 6, 2017 |
Est. completion date | December 31, 2018 |
Verified date | September 2019 |
Source | University Hospitals Coventry and Warwickshire NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 70 Years and older |
Eligibility |
Inclusion Criteria: - Group A: males or females aged > 70 years without major systemic comorbidities (resting blood pressure <140/90 mmHg, no history diabetes mellitus according to WHO criteria). - Group B: males or females aged >70 years with hypertension, defined as a documented blood pressure of Systolic Blood Pressure (SP >140 mmHg or >90mmHg Diastolic Blood Pressure) without diabetes mellitus and HF defined as: a) relevant symptoms/signs/radiographic findings as indicated by Boston criteria b) need for diuretic therapy. - Group C: male or female aged > 70 years with diabetes mellitus (defined according to the World Health Organization (WHO)) AND hypertension, without HF defined as: a) relevant symptoms/signs/radiographic findings as indicated by Boston criteria38 b) need for diuretic therapy. - Group D: male or female aged >70 years with HFPEF, defined as signs and symptoms of HF with LVEF>50% and raised natriuretic peptides (BNP>35pg/ml or NT-proBNP>125pg/ml) along with one other criteria: i) structural heart disease (left atrial enlargement or left ventricular hypertrophy) on TTE, ii) evidence of LV diastolic dysfunction based on ESC Guidelines 2016, or iii) hospitalization with heart failure within 12 months prior to study entry. - Group E (parallel group): male or female aged >70 years with HFREF, defined as HF with LVEF <40% on TTE) Exclusion Criteria: - Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months, or urgent percutaneous coronary intervention (PCI) within 30 days of entry. - Patients who have had an MI, coronary artery bypass graft (CABG) or other event within the 6 months prior to entry unless an echo measurement performed after the event confirms a LVEF =50%. - Current acute decompensated HF requiring intravenous therapy - Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, haemoglobin (Hb) <10 g/dl, or body mass index (BMI) > 40 kg/m2. - Severe left-sided valvular heart disease - Hypotension (systolic BP <100 mm Hg). - Severe Liver failure - Primary pulmonary hypertension - Bedbound/immobile patients - Chronic renal failure with creatinine of >250 µmol/l - Significant Peripheral Vascular Disease (PVD), defined as having signs of absent peripheral pulses or reported claudication pain or documented history of PVD |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospital Coventry and Warwickshire | Coventry |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Coventry and Warwickshire NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Arterial stiffness | As measured by the Pulse Wave Velocity | 30 minutes | |
Secondary | Endothelial function | Laser Doppler Flowmetry | 15 minutes | |
Secondary | Blood test | NT-proBNP | 5 minutes | |
Secondary | Blood test, marker of fibrosis | Galectin-3 | 15 minutes | |
Secondary | Transthoracic echocardiography | Left ventricular systolic and diastolic function, Left atrial size, Valvular assessments, Tissue Doppler imaging, strain rate imaging | 45 minutes | |
Secondary | Exercise Tolerance | Cardio-pulmonary exercise | 30 minutes | |
Secondary | Urinalysis | Albumin, Creatinine and Metabolite profiles ("metabolomics"), related to cardiovascular risk and insulin resistance | 10 minutes |
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