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Exertional dyspnea in patients with suspected heart failure with preserved ejection fraction: are symptoms really caused by impaired left ventricular filling? * A prospective case-control study

Exertional dyspnea in patients with suspected heart failure with preserved ejection fraction: are symptoms really caused by impaired left ventricular filling? * A prospective case-control study - Exertional dyspnea in HFPEF

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36685
Enrollment
36
Registered
2011-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

heart failure

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Group 1: Patients with exertional dyspnea thought to be caused by HFPEF - Exertional dyspnea (NYHA functional class 2 or higher) - All common causes of exertional dyspnea are excluded such as pulmonary disease, anaemia, myocardial ischemia, pulmonary hypertension, systolic heart failure, severe valvular disease, according to the diagnostic algorithm in figure 2. Group 2: Patients suffering from hypertension - Patient suffering from pulmonary hypertension, scheduled for right-sided heart catheterisation

Exclusion criteria

Exclusion criteria: -Inability to give informed consent or refusal to participate in the study -Acute or chronic physical impairment (other than dyspnea) limiting the ability to comply with study requirements -Age 32 kg/m2 -Use of oral anticoagulation -History of stress-induced syncope or ventricular tachycardia during exercise -Significantly impaired left ventricular ejection fraction, i.e. LVEF 2 or signs of silent ischemia during stress-testing (ergospirometry) -Impaired pulmonary function assessed by spirometry

Design outcomes

Primary

MeasureTime frame
Main study parameters are invasively measured cardiac and pulmonary hemodynamics by right heart catheterisation in rest and during exercise, compared between the three study groups.

Secondary

MeasureTime frame
Secondary study parameters are 1) non-invasively measured hemodymics by echocardiographic and Nexfin monitoring compared to invasively measured hemodynamics at rest and during exercise, 2) venous and arterial concentrations of NO-metabolites, endothelin-1, E-selectins, ANP, BNP, AT-II, thrombomodulin and von Willebrand factor at rest and during exercise and 3) heart rate variability between the three study groups.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)