Heart failure patients with mildly reduced and preserved ejection fraction Inspiratory muscle training, Heart failure, exercise capacity
Conditions
Interventions
Participants will inhale against a device with a stable resistance equal to 70% of their maximal inspiratory pressure.
The protocol includes 5 minutes of warm-up, 5 sets with 10 repetitions each set a
Experimental Other,Sham Comparator Other
High intensity inspiratory muscle training,Sham intensity inspiratory muscle training
Sponsors
Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal oxygen consumption 8 weeks Cardiopulmonary exercise test | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactDat Tran
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed