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Heart failure with preserved ejection fraction determination by exercise ultrasonography follow-up

Heart failure with preserved ejection fraction determination by exercise ultrasonography follow-up - HELPFulUP study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51990
Enrollment
170
Registered
2021-05-25
Start date
2021-08-16
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with preserved ejection fraction - Diastolic heart failure

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Participants of the HELPFul study with a baseline diagnosis of LVDD without clinical signs or symptoms of heart failure (stage B heart failure) - Participants consenting to be contacted for follow-up studies of the HELPFul study - Participants who are able to read and understand the Dutch language. - Participants who are willing and able to provide written informed consent for participation in this study. - Participants who agreed that results of the follow-up measurements are reported to the treating physician.

Exclusion criteria

Exclusion criteria: - Participants who received a heart transplantation or left ventricular assist device (LVAD) in the period between baseline and follow-up.

Design outcomes

Primary

MeasureTime frame
The deterioration of LVDD towards HFpEF (stage C/D heart failure), measured by (stress) cardiac ultrasonography assessing functional and structural parameters, combined with natriuretic peptide measurements and clinical evaluation.

Secondary

MeasureTime frame
Paramaters that are collected for exploratory etiological hypothesis generation and further phenotyping of the heterogeneous population of patients with deteriorating diastolic function and HFpEF. Parameters include clinical factors, echocardiography paramaters (such as global longitudinal strain of the left ventricle and the left atrium calculated from standard echocardiography images) and biomarker parameters that can help to explain what individuals in stage B heart failure are at high risk of progression to stage C/D heart failure. Promising blood biomarkers (e.g. omics related to vascular dysfunction) will be measured again, and promising new biomarkers, e.g. BNP measurements after exercise will be added. To further elaborate the cardiorenal syndrome within our cohort urine biomarkers will be measured.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)