Heart Failure With Preserved Ejection FractionHFPEFGlobalNCT04065620
Ambulatory Blood Pressure in HFPEF Outcomes Global Registry
An observational study of Heart Failure With Preserved Ejection Fraction and Arterial Hypertension, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
Heart failure and preserved ejection fraction (HFPEF) is a disease with increasing prevalence world wide. Due to its etiological and prognostic relationship with hypertension, it is highly interesting to know the characteristics and influence of Blood pressure levels and of the hemodynamic biomarkers, measured by… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Arterial Hypertension, Frailty Syndrome
- What is being tested?
- ambulatory blood pressure measurement
- How many people
- 5,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2020to 1 Dec 2023
- 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 18 to 110 years
- All sexes
- Adult, Older adult
Study population: Patients with stable HF-PEF
Who may be able to join
- Patients with a previous diagnosis of HF-PEF, defined by:
- At least a previous hospitalization due to heart failure
- Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch, or within 6 months prior to study entry.
- Symptom(s) of heart failure (HF) and requiring, at least 30 days prior to study entry, hospitalization, or consultation to emergency room .
- Current symptom(s) of HF
- Structural heart disease documented by echocardiogram, namely septal or posterior wall thickness >=1.1 cm) or LA enlargement (i.e., width >=3.8 cm, length >=5.0 cm, area >=20 cm2, volume >=55 ml, or volume index >=29 ml/m
- Elevated NT-proBNP defined as NT-proBNP >200 pg/ml if the patient had been hospitalized for HF within the past 9 months or >300 pg/ml if not so.
- Clinical and hemodynamic stability for at least 4 weeks before study inclusion, defined as stable treatment or functional class for at least 4 weeks before study inclusion, (changes in diuretic dosification are not considered as unstable treatment).
Who cannot join
- Any prior measurement of LVEF ≤ 40%.
- Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , urgent percutaneous coronary intervention or limb amputation due to peripheral arterial disease or Stroke within 3 months or and elective PCI within 30 days prior to entry.
- Current acute decompensated HF requiring therapy.
- Changes in antihypertensive treatment (class type or dose) 4 weeks before inclusion, excluding changes in diuretics due to congestion.
- Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, haemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.
- Systolic blood pressure (SBP) ≥ 180 mmHg or DBP ≥ 110 mmHg at entry.
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- Patients with severe chronic renal disease, defined as GFR <15 ml/min or haemodialysis.
- Inability to understand the study and participate voluntarily
- Patients diagnosed with cancer in the previous 12 months, and requiring treatment, at the time of study inclusion.
- Patients diagnosed with systemic autoimmune disease (lupus, vasculitis . . .)
- Patients not able to perform an ambulatory blood pressure measurement namely working at night, or patients with tachyarrhythmia.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, 08036
Miguel Camafort, MD PhD
About this study
Official title: Evaluation of Ambulatory Blood Pressure Measurement Related Hemodynamic Biomarkers On the Progression of Heart Failure With Preserved Ejection Fraction
Heart failure and preserved ejection fraction (HFPEF) is a disease with increasing prevalence world wide. Due to its etiological and prognostic relationship with hypertension, it is highly interesting to know the characteristics and influence of Blood pressure levels and of the hemodynamic biomarkers, measured by Ambulatory Blood Pressure measurement in the outcome of patients with (HF-PEF), defined by the risk of cardiovascular morbidity and mortality (hospital re-admissions, emergency room visits, functional decline and mortality). The investigators consider other factors such as Frailty, comorbidities, and the baseline functional capacity to asses the prognostic value.
Read the detailed description
The prognosis of patients with heart failure and preserved ejection fraction (HF-PEF), defined by the risk of cardiovascular morbidity and mortality (hospital re-admissions, emergency room visits, functional decline and mortality), depends on multiple factors such as Frailty, comorbidities, BP values, hemodynamic parameters and the baseline functional capacity. Correct definition of these prognostic factors may help define more effective management strategies This is a Prospective observational cohort study, aimed to identify prognostic factors of readmission for heart failure or death in patients with HF-PEF.
Patients with stable HF-PEF will be included monitoring will be by telephone or personal interview every 3 months for at least one year.Specific data on HF will be collected directly from the patient, or from the computerized medical record, with the objective of determining different aspects of HF.
An echocardiogram performed 6 months before inclusion in the case of known HF, or up to 3 months after inclusion, will be considered valid. Parameters collected will include ejection fraction, dimensions of the atrium and ventricle and variables of diastolic dysfunction. ( The procedures for BP measurement, will be according to the ESH/ESC 2018 guidelines, All patients included in the study should have a 12 lead rest EKG performed at study inclusion. Data will be required on renal function (creatinine and glomerular filtration rate and microalbuminuria), lipid parameters (cholesterol: total, HDLc, LDLc,), baseline glucose, glycated hemoglobin (HbA1c), liver biology (GOT, GPT, GGT), albumin and prealbumin, blood cell count, Ferritin and Transferrin saturation rate, natriuretic peptides.
In some centres blood sample will be collected to a further evaluation of biomarkers.
24-hour ABPM will be made using validated devices, ABPM device should be programmed to take measurements every 30 minutes . Patients will be instructed in their use. Periods of activity and rest will be pre-determined in short windows: In addition, the duration of ABPM (hours), the percentage of valid readings, and the mean SBP/DBP values during periods of activity, rest and in 24 hours will be recorded. Records with a duration <24 hours, those without one good reading per hour and those with <70% of satisfactory readings will be excluded. ABPM will be performed at baseline and at the final visit HBPM should be done by a trained individual (the patient or anyone else), with equipment validated, calibrated and provided with memory.
Only validated semiautomatic oscillometric arm cuff devices are recommended for these measurements. The functional status will be determined using the Barthel index, Cognitive impairment will be tested following the Montreal Cognitive Assessment with local adaptations.
The diagnosis of frailty will be made using the Short Physical Performance Battery In a subset of centres a 24H ambulatory ECG recording will be performed using a standard recording unit and automatically analyzed by a PC-based Holter system.
- Conditions
- Heart Failure With Preserved Ejection Fraction, Arterial Hypertension, Frailty Syndrome, Comorbidities and Coexisting Conditions
- Being tested
- ambulatory blood pressure measurement
- Keywords
- Heart Failure with Preserved Ejection Fraction
- Medical subject headings
- Hypertension, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ambulatory blood pressure measurementDiagnostic test
Also called home blood pressure measurement, Short Physical Performance Battery
24-hour ABPM will be made using validated devices, following ABPM device should be programmed to take measurements every 30 minutes . Patients will be instructed in their use. Periods of activity and rest will be pre-determined in short windows: for Asian and European Countries daytime period will be defined between 10:00 and 8:00 pm; and night-time period between 00:00 am and 6:00 am. For Latin American Countries daytime period will be defined between 08:00 and 06:00 pm; and night-time period between 00:00 am and 6:00 am. For Africa daytime period will be defined between 08:00 and 06:00 pm; and night-time period between 11 PM and 5 AM In addition, the duration of ABPM (hours), the percentage of valid readings, and the mean SBP/DBP values during periods of activity, rest and in 24 hours will be recorded. Records with a duration <24 hours, those without one good reading per hour and those with <70% of satisfactory readings will be excluded
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbimortality
Influence of ambulatory Blood pressure measurement derived biomarkers on the incidence of the composite of the number of hospital readmission due to HF, number of CV and non CV death or number of patients with functional decline in patients with HF-PEF
Measured: 1 year
Secondary outcomes (5)
Readmission
Influence of hemodynamic biomarkers of BP measured by ABPM on the number of new hospital readmissions in patients with HF-PEF.
Measured: 1 year
CV mortality
Influence of hemodynamic biomarkers of Blood pressure measured by ABPM on the number of patients with HFPEF presenting CV and non CV death.
Measured: 1 year
Functional decline
Influence of hemodynamic biomarkers of Blood pressure measured by ABPM on the functional decline in patients with HF-PEF, measured by changes in the Barthel index scale
Measured: 1 year
Cognitive decline
Influence of hemodynamic biomarkers of Blood pressure measured by ABPM on the functional decline in patients with HF-PEF, measured by changes in the Montreal Cognitive assessment scales
Measured: 1 year
Frailty
Influence of hemodynamic biomarkers of Blood pressure measured by ABPM on the functional decline in patients with HF-PEF, measured by changes in the short performance battery scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start1 Mar 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Camafort, Hospital Clinic of Barcelona
- Investigators
- Miguel Camafort-Babkowski, MD PhD, Study director, Internal Medicine Department. Hospital Clinic. University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065620
- Sponsor's protocol ID
- MDIUB201901
- Acronym
- HFPEFGlobal
- Status last verified
- Feb 2021
- First submitted
- 25 Jul 2019
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ambulatory Blood Pressure Measurement Related Hemodynamic Biomarkers On the Progression of Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT04065620
- Acronym / sponsor ID
- HFPEFGlobal / MDIUB201901
- Conditions
- Heart Failure With Preserved Ejection Fraction, Arterial Hypertension, Frailty Syndrome, Comorbidities and Coexisting Conditions
- Keywords
- Heart Failure with Preserved Ejection Fraction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 22 Aug 2019 (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.
Heart failure and preserved ejection fraction (HFPEF) is a disease with increasing prevalence world wide. Due to its etiological and prognostic relationship with hypertension, it is highly interesting to know the characteristics and influence of Blood pressure levels and of the hemodynamic biomarkers, measured by Ambulatory Blood Pressure measurement in the outcome of patients with (HF-PEF), defined by the risk of cardiovascular morbidity and mortality (hospital re-admissions, emergency room visits, functional decline and mortality). The investigators consider other factors such as Frailty, comorbidities, and the baseline functional capacity to asses the prognostic value.
Detailed description
The prognosis of patients with heart failure and preserved ejection fraction (HF-PEF), defined by the risk of cardiovascular morbidity and mortality (hospital re-admissions, emergency room visits, functional decline and mortality), depends on multiple factors such as Frailty, comorbidities, BP values, hemodynamic parameters and the baseline functional capacity. Correct definition of these prognostic factors may help define more effective management strategies This is a Prospective observational cohort study, aimed to identify prognostic factors of readmission for heart failure or death in patients with HF-PEF.
Patients with stable HF-PEF will be included monitoring will be by telephone or personal interview every 3 months for at least one year.Specific data on HF will be collected directly from the patient, or from the computerized medical record, with the objective of determining different aspects of HF.
An echocardiogram performed 6 months before inclusion in the case of known HF, or up to 3 months after inclusion, will be considered valid. Parameters collected will include ejection fraction, dimensions of the atrium and ventricle and variables of diastolic dysfunction. ( The procedures for BP measurement, will be according to the ESH/ESC 2018 guidelines, All patients included in the study should have a 12 lead rest EKG performed at study inclusion. Data will be required on renal function (creatinine and glomerular filtration rate and microalbuminuria), lipid parameters (cholesterol: total, HDLc, LDLc,), baseline glucose, glycated hemoglobin (HbA1c), liver biology (GOT, GPT, GGT), albumin and prealbumin, blood cell count, Ferritin and Transferrin saturation rate, natriuretic peptides.
In some centres blood sample will be collected to a further evaluation of biomarkers.
24-hour ABPM will be made using validated devices, ABPM device should be programmed to take measurements every 30 minutes . Patients will be instructed in their use. Periods of activity and rest will be pre-determined in short windows: In addition, the duration of ABPM (hours), the percentage of valid readings, and the mean SBP/DBP values during periods of activity, rest and in 24 hours will be recorded. Records with a duration <24 hours, those without one good reading per hour and those with <70% of satisfactory readings will be excluded. ABPM will be performed at baseline and at the final visit HBPM should be done by a trained individual (the patient or anyone else), with equipment validated, calibrated and provided with memory.
Only validated semiautomatic oscillometric arm cuff devices are recommended for these measurements. The functional status will be determined using the Barthel index, Cognitive impairment will be tested following the Montreal Cognitive Assessment with local adaptations.
The diagnosis of frailty will be made using the Short Physical Performance Battery In a subset of centres a 24H ambulatory ECG recording will be performed using a standard recording unit and automatically analyzed by a PC-based Holter system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with stable HF-PEF
Key inclusion criteria (8 listed)
- Patients with a previous diagnosis of HF-PEF, defined by:
- At least a previous hospitalization due to heart failure
- Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch, or within 6 months prior to study entry.
- Symptom(s) of heart failure (HF) and requiring, at least 30 days prior to study entry, hospitalization, or consultation to emergency room .
- Current symptom(s) of HF
Key exclusion criteria (11 listed)
- Any prior measurement of LVEF ≤ 40%.
- Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , urgent percutaneous coronary intervention or limb amputation due to peripheral arterial disease or Stroke within 3 months or and elective PCI within 30 days prior to entry.
- Current acute decompensated HF requiring therapy.
- Changes in antihypertensive treatment (class type or dose) 4 weeks before inclusion, excluding changes in diuretics due to congestion.
- Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, haemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.
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 |
|---|---|---|
| ambulatory blood pressure measurementAlso: home blood pressure measurement, Short Physical Performance Battery24-hour ABPM will be made using validated devices, following ABPM device should be programmed to take measurements every 30 minutes . Patients will be instructed in their use. Periods of activity and rest will be pre-determined in short windows: for Asian and European Countries daytime period will be defined between 10:00 and 8:00 pm; and night-time period between 00:00 am and 6:00 am. For Latin American Countries daytime period will be defined between 08:00 and 06:00 pm; and night-time period between 00:00 am and 6:00 am. For Africa daytime period will be defined between 08:00 and 06:00 pm; and night-time period between 11 PM and 5 AM In addition, the duration of ABPM (hours), the percentage of valid readings, and the mean SBP/DBP values during periods of activity, rest and in 24 hours will be recorded. Records with a duration <24 hours, those without one good reading per hour and those with <70% of satisfactory readings will be excluded | Diagnostic test | – |
Primary outcome
Morbimortality
Time frame: 1 year
Influence of ambulatory Blood pressure measurement derived biomarkers on the incidence of the composite of the number of hospital readmission due to HF, number of CV and non CV death or number of patients with functional decline in patients with HF-PEF
5 secondary outcomes
Readmission
Time frame: 1 year
CV mortality
Time frame: 1 year
Functional decline
Time frame: 1 year
Cognitive decline
Time frame: 1 year
Frailty
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Miguel Camafort-Babkowski, MD PhD study director
Internal Medicine Department. Hospital Clinic. University of Barcelona
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 Preserved Ejection Fraction and Arterial Hypertension, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 8 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: status not confirmed, as of the sponsor's last update on 25 Feb 2021. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miguel Camafort-Babkowski, MD PhD (+34600752824, camafort@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbimortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2021.