Cycle ergometer exercise catheterization for the early diagnosis of heart failure with preserved ejection fraction or pulmonary hypertension

JRCT ID: jRCTs032200121

Registered date:16/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure with preserved ejection fraction or pulmonary hypertension
• Date of first enrollment: 16/09/2020
• Target sample size: 110
• Study type: Interventional
• Intervention(s): Cycle ergometer exercise during right heart catheterization

Outcome(s)

• Primary Outcome: Pulmonary capillary wedge pressure/pulmonary pressure during exercise
• Secondary Outcome: none

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Age equal to or more than 20 years old
2) Left ventricular ejection fraction on echocardiography equal or more than 50%
3) Subjects who are suspected of heart failure of pulmonary hypertension
4) Subjects who will undergo diagnostic right heart catheterization for evaluation of heart failure or pulmonary hypertension
5) Subjects who are able to keep cycle ergometry exercise for more than 30 seconds
6) Patients who give written consent to participate in this study

Exclude criteria

1) Patients with apparent heart failure or pulmonary hypertension on non-invasive testings
2) Patients with complications contraindicated for exercise testing
3) Patients who cannot exercise their legs due to abnormalities in joints, muscles, etc.
4) Patients who are judged to be unsuitable for the study by the investigators

Related Information

• Primary Sponsor: Obokata Masaru