Ambulatory Blood Pressure in HFPEF Outcomes Global Registry

NCT04065620 | Unknown

• 1 other identifier: MDIUB201901
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction; Arterial Hypertension; Frailty Syndrome; Comorbidities and Coexisting Conditions

Keywords

Heart Failure with Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (5)

• Readmission

  1 year

• CV mortality

  1 year

• Functional decline

  1 year

• Cognitive decline

  1 year

• Frailty

  1 year

Other Outcomes (2)

• Influence of cognitive impairment on outcomes in HFPEF

  1 year

• Influence of frailty on outcomes in HFPEF

  1 year

Interventions

ambulatory blood pressure measurement DIAGNOSTIC_TEST

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

Also known as: home blood pressure measurement, Short Physical Performance Battery

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stable HF-PEF

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 systemic autoimmune disease (lupus, vasculitis . . .)
• Patients not able to perform an ambulatory blood pressure measurement namely working at night, or patients with tachyarrhythmia.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Hypertension; Frailty

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Miguel Camafort-Babkowski, MD PhD

  Internal Medicine Department. Hospital Clinic. University of Barcelona

  STUDY DIRECTOR

Central Study Contacts

Miguel Camafort-Babkowski, MD PhD

CONTACT

+34600752824; camafort@clinic.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Miguel Camafort-Babkowski MD PhD. Principal Investigator. Consultant Physician, Internal Medicine department. Heart Failure Unit .

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 22, 2019
• Study Start: March 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

ES (1)