Effects of high intensity of inspiratory muscle training in patients with heart failure with mildly reduced and preserved ejection fraction: A randomized controlled trial
- Conditions
- Heart failure patients with mildly reduced and preserved ejection fractionInspiratory muscle training, Heart failure, exercise capacity
- Registration Number
- TCTR20231121001
- Lead Sponsor
- Faculty of Medicine, Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 29
1.Patients with symptoms and signs of chronic HF with a LVEF of more than 40% and no prior measurement of LVEF equal or less than 40% at baseline.
2.Patients with NYHA class II or III.
3.Patients with NT-pro BNP greater than 220 pg/dL or elevated LV filling pressure at rest or with exercise assessed by echocardiography.
4.Patients who have been on a stable dose of HF medications for at least 4 weeks.
1.Patients who are unable to perform a baseline exercise test: gait difficulty, orthopedic problems, etc. that affect their ability to walk.
2.Patients who need intravenous diuretics, vasodilators, inotropic agents, or mechanical support within a week of screening, as well as during the screening period before randomization, and have acute decompensated HF.
3.Patients with recent angina or open-heart surgery within 3 months prior to randomization.
4.Patients with end-stage renal disease and require renal replacement therapy or kidney transplantation
5.Patients with status post-heart transplantation
6.Patients with anemia (Hb less than 10 g/dl)
7.Patients with significant primary moderate to severe valvular disease.
8.Patients with significant primary pulmonary disease, including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease.
9.Patients who have systemic diseases such as amyloidosis or sarcoidosis.
10.Patients with any other comorbidities with life expectancy less than 1 year.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximal oxygen consumption 8 weeks Cardiopulmonary exercise test
- Secondary Outcome Measures
Name Time Method 6-minute walk distance 8 weeks 6-minute walk test,Maximal inspiratory pressure 8 weeks Maximal inspiratory pressure test,Quality of life 8 weeks 36-Item Short Form Survey,Diastolic function 8 weeks Echocardiography,Experience of fatigue and/or Fainting 8 weeks Clinical assessment