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Ambulatory Blood Pressure in HFPEF Outcomes Global Registry

NCT04065620 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2021-02-25

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Miguel Camafort-Babkowski, MD PhD · Internal Medicine Department. Hospital Clinic. University of Barcelona

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-12-01
Completion
2023-12-01

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04065620 on ClinicalTrials.gov