Role of Cardiopulmonary Exercise Testing in People With Heart Failure With Preserved Ejection Fraction

NCT07394010 | Completed DMC

• 3 other identifiers: FCNUR-23-06623/NI/0167IRAS Project ID:32821
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure affects 1-2% of the adult population. Up to half of these patients have apparently normal heart pumping function, known as heart failure with preserved ejection fraction (HFpEF). Because HFpEF typically occurs in elderly patients with multiple comorbidities, many different mechanisms could drive symptoms and life expectancy, and it has been difficult to find effective treatments that work for all. Symptoms of HFpEF occur during exertion. The current scoring system for the diagnosis of HFpEF is not able to identify the majority of people and the majority of people remain in the zone of diagnostic uncertainty; there is no definite follow-up strategy, thus people do not receive appropriate treatment. Also, the medications, prehabilitation, and rehabilitation services are not personalised. To cater to these gaps in clinical practice, this study was set up to use Cardiopulmonary exercise testing (CPET) to understand the complexity of this disease. The investigators plan to recruit patients with clinical suspicion of HFpEF, referred to the Cardiology Department at Ulster Hospital, Belfast, UK. After screening the medical records of patients based on the inclusion and exclusion criteria, the investigators recruited 40 patients to undergo a cardiopulmonary exercise test. CPET parameters related to the heart, lungs and muscles were recorded in real time, as the patient exercised on the bike to maximal effort. The CPET data were then analysed to answer the above-mentioned clinical gaps. To disseminate the findings, the investigators plan to present the results at scientific, clinical, and patient group meetings and publish the findings in medical journals, to reach a wide array of healthcare professionals and policymakers.

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Keywords

Cardiopulmonary Exercise Testing; CPET; HFpEF; Heart Failure with Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Maximum Oxygen Consumption at peak exercise (VO2peak)

  Measure of exercise capacity.

  CPET testing day. VO2peak is recorded as the oxygen consumption value measured by the gas sensor at the peak of exercise, i.e., seconds before maximal exhaustion.

Secondary Outcomes (3)

• First Ventilatory Threshold

  CPET testing day. Measured during the initial 3 minutes of the incremental test phase.

• Heart Rate

  Baseline, every 2 minutes interval, and at peak exercise near maximal exhaustion.

• Blood Pressure

  Every 3-minute interval during the exercise test.

Study Arms (1)

Patents referred to Cardiology Department with a clinical suspicion of HFpEF

Males and Females Age range: 18 to 80 Ejection fraction \>50% on the latest Echocardiography No Hospital admission in the past 6 months No pregnant No absolute contraindication for conducting an exercise test.

Other: Cardiopulmonary Exercise Test

Interventions

Cardiopulmonary Exercise Test OTHER

It is the gold standard for assessing cardiorespiratory fitness. It assesses the combined functional capacity of the multiple systems of the body.

Also known as: CPET

Patents referred to Cardiology Department with a clinical suspicion of HFpEF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients registered with the South Eastern Health and Social Trust (NHS), Northern Ireland, UK.

You may qualify if:

• Male and female
• Age range between 18 - 80 years
• Clinical suspicion of Heart failure with preserved ejection fraction
• Ejection Fraction of ≥50% on the most recent Echocardiogram
• Able to understand the performance of an exercise test and the ability to provide consent
• Ability to undertake leg exercise without any impediment

You may not qualify if:

• Hospital admission in the past 6 months
• Unable to understand the performance of an exercise test
• Unable to provide informed consent
• Female subjects who are knowingly pregnant or believe they may be pregnant
• Having an impediment preventing them from performing cycle ergometry
• Contra-indication of CPET: acute myocardial infarction, unstable angina, uncontrolled arrhythmias, moderate or severe valvular disease, High-degree atrioventricular block, acute infection, acute endocarditis, myocarditis, uncontrolled asthma, and history of syncope.

Sponsors & Collaborators

• University of Ulster: lead
• Ulster Hospital, Northern Ireland: collaborator

Study Sites (1)

Ulster University and Ulster Hospital

Belfast, Middlesex, BT16 1RH, United Kingdom

Location

Related Links

• Cardiopulmonary exercise testing in heart failure with preserved ejection fraction: a game-changer for patients.

MeSH Terms

Interventions

Exercise Test; Clostridium perfringens epsilon-toxin

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Chris Bleakley, PhD

  Ulster University, Belfast, UK

  STUDY DIRECTOR

• George Kernohan, PhD

  Ulster University, Belfast, UK

  STUDY DIRECTOR

• Peter McKavanagh, MD, PhD

  Ulster Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 6, 2026
• Study Start: June 1, 2023
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From March 2026 onwards
• Access Criteria: Freely available online for anyone to access

Locations

GB (1)