OBESE-HFpEF - towards preventing obesity related HFpEF

'OBESE-HFpEF: Prevalence and mediators of Heart Failure (Preserved Ejection Fraction) in the Bariatric Clinic – towards preventing obesity related HFpEF' - OBESE-HFpEF - towards preventing obesity related HFpEF

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57864

Enrollment

250

Registered

2025-02-27

Start date

2026-01-06

Completion date

Unknown

Last updated

2026-01-27

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, Heart failure with preserved pumpfunction Obesity

Interventions

Due to the observational nature of our study, no product or intervention is used in our study.&nbsp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 35 years of age or older- Indication for surgical treatment for obesity according to the Dutch guideline i.e  BMI = 40 kg/m2 or a BMI = 35 kg/m2 with one or more comorbidities associated with obesity. 

Exclusion criteria

Exclusion criteria: Inability to provide informed consentA BMI >60 kg/m2Inability to safely undergo metabolic bariatric surgeryInability to undergo study measurements/testsNot proficient in the Dutch languageA medical history of a reduced ejection fraction <40%, severe cardiac valve defects or congenital heart defectsA medical history of previous metabolic bariatric surgery

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is: total percentage of patients with obesity and (pre-)HFpEF in our study population.  This will be meassured by echocardiography, physical examination and meassurement of natriuretic peptides. HFpEF is defined as follows: Those with symptoms and signs of HF , with evidence of structural and/or functional cardiac abnormalities and/or raised natriuretic peptides (NPs), and with a LVEF =50%.	—

Measure

Time frame

The primary outcome measure is: total percentage of patients with obesity and (pre-)HFpEF in our study population.  This will be meassured by echocardiography, physical examination and meassurement of natriuretic peptides. HFpEF is defined as follows: Those with symptoms and signs of HF , with evidence of structural and/or functional cardiac abnormalities and/or raised natriuretic peptides (NPs), and with a LVEF =50%.   

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Secondary

Measure	Time frame
Secondary outcomes are:Mean difference in mechanistic mediators (laboratory, antropomorphology, fat biopsy) between the different groups (Obese-HFpEF, obese-preHFpEF, obesity without HF)Delta in total percentage of (pre-)HFpEF after MBS, at 1 and 2 years follow-upDelta in measures from point 1. (excluding fat biopsy parameters) from BL to 1- and 2 year follow-up.Delta in EQ-5D questionnaire quality of life scores after MBS, at 1 and 2 years follow-upDelta in functional capacity after MBS, meassured in difference of six-minute walking test distance, at 1 and 2 years follow-up.	—

Measure

Time frame

Secondary outcomes are:Mean difference in mechanistic mediators (laboratory, antropomorphology, fat biopsy) between the different groups (Obese-HFpEF, obese-preHFpEF, obesity without HF)Delta in total percentage of (pre-)HFpEF after MBS, at 1 and 2 years follow-upDelta in measures from point 1. (excluding fat biopsy parameters) from BL to 1- and 2 year follow-up.Delta in EQ-5D questionnaire quality of life scores after MBS, at 1 and 2 years follow-upDelta in functional capacity after MBS, meassured in difference of six-minute walking test distance, at 1 and 2 years follow-up.

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Countries

Netherlands

Contacts

Public ContactLEE Peeters

Zuyderland

luka.peeters@zuyderland.nl+32479092470

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026