Diastolic Heart Failure
Conditions
Brief summary
A multicenter randomized controlled trial, with follow-up at 6 and 12 months. Physically inactive participants with chronic heart failure with preserved or mid-range ejection fraction will be randomly assigned to intervention or control arms. The six-month intervention will consist of an individualized pedometer-based walking program with weekly step goals, monthly face-to-face sessions with the physician, and monthly telephone calls with the research nurse. The intervention will be based on effective behavioral principles (goal setting, self-monitoring, personalized feedback). The primary outcome is the change in 6-minute walk distance at 6 months. Secondary outcomes include changes in serum biomarkers levels, pulmonary congestion assessed by ultrasound, average daily step count measured by accelerometry, anthropometric measures, symptoms of depression, health-related quality of life, self-efficacy, and MAGGIC Risk Score.
Interventions
BEHAVIORALWalking intervention
The intervention will be delivered over a six-month period and will consist of: (1) an individualized pedometer-based walking program with weekly step goals, (2) regular visits to the clinic including face-to-face session with the physician, and (3) regular telephone calls with the research nurse in between the face-to-face contacts.
Sponsors
General University Hospital, Prague
Brno University Hospital
University Hospital Olomouc
University Hospital Hradec Kralove
Tomas Bata Hospital, Czech Republic
Charles University, Czech Republic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of heart failure with preserved (HFpEF) or mid-range (HFmrEF) ejection fraction with New York Heart Association (NYHA) class II or III symptoms. The diagnosis requires the following conditions to be fulfilled: 1. the presence of symptoms and/or signs of heart failure, 2. left ventricular ejection fraction ≥50% (HFpEF) or 40-49% (HFmrEF), 3. elevated levels of natriuretic peptides (BNP \>35 pg/ml and/or NT-proBNP \>125 pg/mL), 4. objective evidence of other cardiac functional and structural alterations underlying heart failure. 2. Physically inactive, as determined by a question As a rule, do you do at least half an hour of moderate or vigorous exercise (such as walking or a sport) on five or more days of the week?.
Exclusion criteria
1. Signs and symptoms of decompensated heart failure, uncontrolled arrhythmia or effort angina, severe or symptomatic aortic stenosis, persistent hypotension, recent shocks delivered by the automated implantable cardioverter defibrillator. 2. Co-morbid conditions that would affect adherence to trial procedures (e.g. inflammatory arthritis, active malignancy, renal disease requiring dialysis, uncontrolled diabetes, major depression or other significant psychiatric disorders, cognitive impairment, significant hearing or visual impairment). 3. Major surgery planned within the next 12 months. 4. Life expectancy shorter than 12 months. 5. Inability to walk from any reason. 6. Baseline six-minute walking distance \>450 meters. Patients covering more than 450 meters in the baseline six-minute walk test (6MWT) are excluded due to a possible ceiling effect. 7. Pregnancy. 8. Failure to perform the 6MWT.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| functional capacity | 6 months | functional capacity change measured with 6-minute walk test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NT-proBNP | 6 months | N-terminal pro-B-type natriuretic peptide levels |
| hsCRP | 6 months | high-sensitivity C-reactive protein |
| pulmonary congestion | 6 and 12 months | assessed by ultrasound detection of B-lines |
| physical activity | 6 and 12 months | average daily step count measured over 7 days by ActiGraph |
| depression | 6 and 12 months | assessed with the Beck Depression Inventory-II |
| functional capacity | 12 months | functional capacity change measured with 6-minute walk test |
| self-efficacy | 6 and 12 months | assessed with the Czech version of the General Self-Efficacy scale (DOVE) |
| body mass index | 6 and 12 months | calculated by dividing the body weight (kg) by the square of the height (m2) |
| waist circumference | 6 and 12 months | recorded with a measurement tape to the nearest 0.1 cm |
| hip circumference | 6 and 12 months | recorded with a measurement tape to the nearest 0.1 cm |
| Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score | 6 and 12 months | method to predict survival in heart failure patients |
| health-related quality of life | 6 and 12 months | assessed with the 36-Item Short Form Health Survey (SF-36) |
Countries
Czechia
Contacts
Primary ContactJan Belohlavek, Ass. Prof.
Outcome results
None listed