Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04065620 |
Other study ID # |
MDIUB201901 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 1, 2020 |
Est. completion date |
December 1, 2023 |
Study information
Verified date |
February 2021 |
Source |
Hospital Clinic of Barcelona |
Contact |
Miguel Camafort-Babkowski, MD PhD |
Phone |
+34600752824 |
Email |
camafort[@]clinic.cat |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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 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.
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.