Heart Failure With Normal Ejection Fraction Clinical Trial
Official title:
Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction
Heart failure (HF) with preserved ejection fraction (HFpEF) has become the most prevalent form of HF in developed countries. Despite its increasing in prevalence, there is no evidence-based effective therapy for HFpEF The purpose of this study was to evaluate whether inspiratory muscle training (IMT), functional electrical stimulation (FES), or combination of both improve exercise capacity as well as left ventricular diastolic function, biomarkers' profile, quality of life (QoL) and prognosis in patients with HFpEF.
This study was designed as a prospective, controlled, randomized, four-armed, efficacy trial
of patients with the diagnosis of HFpEF and New York Heart Association functional class
II-III/IV, diagnosed according to criteria of the European Society of Cardiology. A
computer-generated randomization scheme was used to allocate participants (in a 1:1:1:1
ratio) to receive: 1) a home-based 12-week program of inspiratory muscle training (IMT) or;
2) a 12-week program of functional electrical stimulation (FES) of lower limb muscles or; 3)
standard treatment (ST) alone or; 4) combination of IMT and FES. The study is being
conducted in a single center in Spain. Independently of staggered entry, the minimum
duration of a patient's participation is 6 months (from first to last visit). All patients
will provide signed informed consent and the protocol has been approved by the research
ethics committee of our center in accordance with the principles of the Declaration of
Helsinki and national regulations.
Study population Candidate patients are selected from the outpatient's clinics of HF of the
Hospital Clínico Universitario of Valencia.
Study objectives The primary endpoint of the study is a clinical endpoint of three and six
months change in peak oxygen uptake (peak VO2).
Secondary endpoints are three and six month changes in echocardiogram parameters, QoL and
prognostic biomarkers. The investigators also will specifically focus on number of episodes
of worsening HF at 6 months:
1. Change in E/e' after three and six months.
2. Change in left atrial volume index after three and six months.
3. Change in health-related QoL measured by the Minnesota Living With Heart Failure
Questionnaire (MLHF) after three and six months.
4. Change in natriuretic peptide (NT-proBNP) after three and six months.
5. Change in minute ventilation/carbon dioxide production (VE/VCO2) slope after three and
six months.
6. Number of episodes of acute HF hospitalizations and number of episodes of worsening HF
not requiring hospitalization at 6 months.
Intervention
Eligibility assessment and screening visit After reviewing the inclusion/exclusion criteria
and signing the informed consent form, a comprehensive medical history, physical
examination, anthropometry and examination tests will be performed. The examination tests
include: electrocardiogram (ECG) echocardiography, cardiopulmonary exercise testing (CPET),
6-minute walk test (6-MWT), inspiratory muscle function test, QoL assessment by the
Minnesota Living With Heart Failure Questionnaire (MLHF) and blood samples for a panel of
baseline biomarkers.
Finally, patients are randomized (1:1:1:1) to four groups: 1) ST alone or; 2) a home-based
12-week program of IMT or; 3) a 12-week program of FES or; 4) combination of IMT and FES
(IMT+FES) during 12 weeks.
12-week and six months visits All patients will be evaluated after 12-week supervised
training, and six months after randomization. Evaluation will include medical history,
physical examination, anthropometry and functional and QoL assessment tests (ECG, CPET,
6-MWT, inspiratory muscle function test, MLHF and blood tests).
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
Completed |
NCT02173548 -
Interleukin-1 Blockade in HF With Preserved EF
|
Phase 2 | |
Completed |
NCT02459626 -
Left Ventricular Stiffness vs. Fibrosis Quantification by T1 Mapping in Heart Failure With Preserved Ejection Fraction
|
||
Completed |
NCT03310099 -
Unsaturated Fatty Acids Enriched-diet to Improve Cardiorespiratory Fitness, Metabolic Flexibility and Glucose Tolerance in Obese Patients
|
N/A | |
Completed |
NCT03871803 -
β-blockers Withdrawal in Patients With HFpEF and Chronotropic Incompetence: Effect on Functional Capacity (Preserve-HR)
|
Phase 4 | |
Completed |
NCT03672591 -
Renal Hemodynamics in Patients With HFpEF
|
||
Recruiting |
NCT03620526 -
Inhaled Iloprost and Exercise Hemodynamics and Ventricular Performance in Heart Failure With Preserved Ejection Fraction
|
Phase 4 | |
Active, not recruiting |
NCT03624010 -
Open-Label Rollover Study of Levosimendan in PH-HFpEF Patients
|
Phase 2 | |
Completed |
NCT03541603 -
Hemodynamic Evaluation of Levosimendan in Patients With PH-HFpEF
|
Phase 2 | |
Completed |
NCT03141567 -
LYmphangiogenesis FacTors in Heart Failure States
|
||
Completed |
NCT02744339 -
Pharmacodynamic Effects of Riociguat in Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
|
Phase 2 | |
Completed |
NCT03387813 -
Hemodynamic-GUIDEd Management of Heart Failure
|
N/A | |
Completed |
NCT03186833 -
The Heart Failure With Preserved Ejection Fraction (HFpEF) Pathophysiology Study.
|
||
Completed |
NCT03289481 -
Treatment of HFpEF With Nitrate Supplement
|
Early Phase 1 | |
Terminated |
NCT03195660 -
Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study
|
N/A | |
Completed |
NCT03226652 -
Heart Function in Patients Assessed for Sleep Apnoea
|
||
Completed |
NCT03966755 -
Unsaturated Fatty Acids to Improve Cardiorespiratory Fitness in Obesity and HFpEF
|
N/A | |
Not yet recruiting |
NCT04282850 -
Ablation Versus Medical Management of Atrial Fibrillation in HFpEF
|
N/A | |
Recruiting |
NCT03184311 -
High-intensity Interval Training in Heart Failure Patients With Preserved Ejection Fraction
|
N/A | |
Withdrawn |
NCT03317314 -
Cardiopulmonary Interactions in Patients With Heart Failure
|