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

Withdrawn

Conditions: heart failure
10019280

Registration Number: NL-OMON36685

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 36

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

-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 <18 years
-Body mass index (BMI) of > 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 < 45%
-Symptoms and signs of congestive heart failure at rest (i.e. NYHA IV)
-Angina pectoris CCS > 2 or signs of silent ischemia during stress-testing (ergospirometry)
-Impaired pulmonary function assessed by spirometry

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters are invasively measured cardiac and pulmonary<br /><br>hemodynamics by right heart catheterisation in rest and during exercise,<br /><br>compared between the three study groups. </p><br>

Secondary Outcome Measures

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