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Ambulatory Blood Pressure in HFPEF Outcomes Global Registry (HFPEFGlobal)

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ClinicalTrials.gov Identifier: NCT04065620
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Miguel Camafort, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date July 25, 2019
First Posted Date August 22, 2019
Last Update Posted Date February 11, 2020
Estimated Study Start Date March 1, 2020
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 21, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 21, 2019)
  • Readmission [ Time Frame: 1 year ]
    Influence of hemodynamic biomarkers of BP measured by ABPM on the number of new hospital readmissions in patients with HF-PEF.
  • CV mortality [ Time Frame: 1 year ]
    Influence of hemodynamic biomarkers of Blood pressure measured by ABPM on the number of patients with HFPEF presenting CV and non CV death.
  • Functional decline [ Time Frame: 1 year ]
    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
  • Cognitive decline [ Time Frame: 1 year ]
    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
  • Frailty [ Time Frame: 1 year ]
    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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 21, 2019)
  • Influence of cognitive impairment on outcomes in HFPEF [ Time Frame: 1 year ]
    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 related to baseline Montreal Cognitive Assessment scale Values
  • Influence of frailty on outcomes in HFPEF [ Time Frame: 1 year ]
    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 related to baseline Short Physical Performance Battery Values
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Ambulatory Blood Pressure in HFPEF Outcomes Global Registry
Official Title Evaluation of Ambulatory Blood Pressure Measurement Related Hemodynamic Biomarkers On the Progression of Heart Failure With Preserved Ejection Fraction
Brief 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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum samples
Sampling Method Non-Probability Sample
Study Population Patients with stable HF-PEF
Condition
  • Heart Failure With Preserved Ejection Fraction
  • Arterial Hypertension
  • Frailty Syndrome
  • Comorbidities and Coexisting Conditions
Intervention Diagnostic Test: ambulatory blood pressure measurement
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
Other Names:
  • home blood pressure measurement
  • Short Physical Performance Battery
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 21, 2019)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 1, 2022
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Miguel Camafort-Babkowski, MD PhD +34600752824 camafort@clinic.cat
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04065620
Other Study ID Numbers MDIUB201901
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Miguel Camafort, Hospital Clinic of Barcelona
Study Sponsor Hospital Clinic of Barcelona
Collaborators Not Provided
Investigators
Study Director: Miguel Camafort-Babkowski, MD PhD Internal Medicine Department. Hospital Clinic. University of Barcelona
PRS Account Hospital Clinic of Barcelona
Verification Date February 2020