Heart Failure With Normal Ejection FractionIDENTIFY-HFNCT03186833
The Heart Failure With Preserved Ejection Fraction (HFpEF) Pathophysiology Study.
An observational study of Heart Failure With Normal Ejection Fraction, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Normal Ejection Fraction
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Group A: males or females aged > 70 years without major systemic Group B: males or females aged >70 years with hypertension Group C: male or female aged > 70 years with diabetes mellitus AND hypertension, without HF Group D: male or female aged >70 years with HFpEF Group E: male or female aged >70 years with HFREF, defined as HF with LVEF <40% on TTE)
Who may be able to join
- 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)
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Coventry and Warwickshire
Coventry, CV2 2DX
About this study
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
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:
Read more
- 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.
Read the 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
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: no intervention | |
| 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. Receives: Other: no intervention | |
| 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. Receives: Other: no intervention | |
| 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. Receives: Other: no intervention | |
| Group E | male or female aged >70 years with HFREF, defined as HF with LVEF <40% on TTE) Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
As measured by the Pulse Wave Velocity
Measured: 30 minutes
Secondary outcomes (6)
Endothelial function
Laser Doppler Flowmetry
Measured: 15 minutes
Blood test
NT-proBNP
Measured: 5 minutes
Blood test, marker of fibrosis
Galectin-3
Measured: 15 minutes
Transthoracic echocardiography
Left ventricular systolic and diastolic function, Left atrial size, Valvular assessments, Tissue Doppler imaging, strain rate imaging
Measured: 45 minutes
Exercise Tolerance
Cardio-pulmonary exercise
Measured: 30 minutes
Urinalysis
Albumin, Creatinine and Metabolite profiles ("metabolomics"), related to cardiovascular risk and insulin resistance
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start6 Jun 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Normal Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prithwish Banerjee, MD, FRCP, Study director, University Hospital Coventry and Warwickshire, Coventry UniversityFrancesco Cappuccio, MD, MSc, DSc, Study chair, University of WarwickMartin Weickert, MD, FRCP, Study chair, University Hospital Coventry and Warwickshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186833
- Sponsor's protocol ID
- PB186316
- Acronym
- IDENTIFY-HF
- Status last verified
- Sep 2019
- First submitted
- 9 Jun 2017
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali D, Callan N, Ennis S, Powell R, McGuire S, McGregor G, Weickert MO, Miller MA, Cappuccio FP, Banerjee P. Heart failure with preserved ejection fraction (HFpEF) pathophysiology study (IDENTIFY-HF): does increased arterial stiffness associate with HFpEF, in addition to ageing and vascular effects of comorbidities? Rationale and design. BMJ Open. 2019 Nov 19;9(11):e027984. doi: 10.1136/bmjopen-2018-027984.
PubMed 31748285
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03186833
- Acronym / sponsor ID
- IDENTIFY-HF / PB186316
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: no interventionmales 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 | – | Other: no interventionmales 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 | – | Other: no interventionmale 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 | – | Other: no interventionmale 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 | – | Other: no interventionmale or female aged >70 years with HFREF, defined as HF with LVEF <40% on TTE) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Group A: males or females aged > 70 years without major systemic Group B: males or females aged >70 years with hypertension Group C: male or female aged > 70 years with diabetes mellitus AND hypertension, without HF Group D: male or female aged >70 years with HFpEF Group E: male or female aged >70 years with HFREF, defined as HF with LVEF <40% on TTE)
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Group A, Group B, Group C, Group D, Group E |
Primary outcome
Arterial stiffness
Time frame: 30 minutes
As measured by the Pulse Wave Velocity
6 secondary outcomes
Endothelial function
Time frame: 15 minutes
Blood test
Time frame: 5 minutes
Blood test, marker of fibrosis
Time frame: 15 minutes
Transthoracic echocardiography
Time frame: 45 minutes
Exercise Tolerance
Time frame: 30 minutes
Urinalysis
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Derived from this study: PubMed 31748285Ali D, Callan N, Ennis S, Powell R, McGuire S, McGregor G, Weickert MO, Miller MA, Cappuccio FP, Banerjee P. Heart failure with preserved ejection fraction (HFpEF) pathophysiology study (IDENTIFY-HF): does increased arterial stiffness associate with HFpEF, in addition to ageing and vascular effects of comorbidities? Rationale and design. BMJ Open. 2019 Nov 19;9(11):e027984. doi: 10.1136/bmjopen-2018-027984.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prithwish Banerjee, MD, FRCP study director
University Hospital Coventry and Warwickshire, Coventry University
Francesco Cappuccio, MD, MSc, DSc study chair
University of Warwick
Martin Weickert, MD, FRCP study chair
University Hospital Coventry and Warwickshire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Normal Ejection Fraction, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03186833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.