Clinical trial NCT05726474: Comparison of the Effect of Two Types of Physical Exercises in Patients With Heart Failure With Preserved Ejection Fraction
Official title: Comparison of the Effect of Two Types of Physical Exercise on the Improvement of Exercise Capacity, Diastolic Function, Endothelial Function, and Arterial Stiffness in Patients With Heart Failure With Preserved Ejection Fraction (ExIC-FEp Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Physical Exercise
Exercise Capacity
Diastolic Function
Endothelial Function
Arterial Stiffness
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2023-02-14
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Heart failure (HF) is a chronic disease with a very important and increasingly severe social and health impact with a prevalence of 6.8% in Spain. HF with preserved ejection fraction (HFpEF) represents approximately 50% of all patients with HF. In the absence of pharmacological treatments that have succeeded in reducing mortality or morbidity in this pathology, it is recommended that interventions be directed at prevention, symptomatic treatment of HF and treatment of comorbidities to avoid exacerbations, thus physical exercise is recognized as an important adjunct in the treatment of HF and is recommended by the guidelines of the American College of Cardiology (ACC)/American Heart Association (AHA) and the European Society of Cardiology (ESC). Currently, aerobic exercise is the most studied physical exercise in this population, but in recent years high-intensity interval training (HIIT) and the combination of aerobic exercise with strength training (combined exercise) have emerged.

Objectives: The overall objective of this study is to compare the effectiveness of combined training and HIIT on exercise capacity, diastolic function, endothelial function, and arterial stiffness in patients with HFpEF. The specific objectives of this study are: a) to compare the effectiveness of combined training and HIIT on quality of life in patients with HFpEF and b) to analyze the cost-effectiveness of combined training and HIIT versus conventional treatment in patients with HFpEF.

Methodology: The ExIC-FEp study will be a single-blind randomized clinical trial with 3 arms (combined exercise, HIIT and a control group), conducted at the Health and Social Research Center of the University of Castilla-La Mancha, to analyze two types of supervised physical exercise in patients with HFpEF for 6 months. Patients with HFpEF will be randomly assigned (1:1:1) to the combined exercise, HIIT or control group. All participants will be examined, at baseline (prior to randomization), at three months (mid-intervention) and at six months (at the end of the intervention). Participants will undergo physical examination, echocardiography, maximal cardiopulmonary stress test, and measurement of endothelial function and arterial stiffness. In addition, sociodemographic variables, quality of life, physical activity, adherence to the Mediterranean diet, strength, spirometry and blood sampling will be measured.

Expected scientific contributions: this randomized clinical trial will represent a a significant advance in the scientific evidence available on the efficacy of physical exercise in the treatment of HFpEF, through: (a) transfer of the results to physicians, nurses and patients; (b) dissemination of results through scientific articles, doctoral theses and participation in congresses; (c) press releases and press conferences with the aim of disseminating the research results to the population; (d) dissemination through social networks to improve the social impact; and (e) design and content development of a web page.


Eligibility criteria: Inclusion Criteria:

1. Heart Failure with preserved ejection fraction picture (diagnosis according to ESC 2021 criteria)

   1. Signs and symptoms of Heart Failure
   2. A left ventricular ejection fraction of ≥50%.
   3. Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of left ventricular diastolic dysfunction/elevated left ventricular filling pressures, including elevated natriuretic peptides.
2. Sedentary men and women (structured exercise \<2 x 30 min/week).
3. Age ≥40 years
4. Written informed consent
5. Clinically stable for 6 weeks
6. Optimal medical treatment for ≥6 weeks

Exclusion Criteria:

1. Non-cardiac causes of heart failure symptoms:

   * Significant valvular or coronary artery disease - Uncontrolled hypertension or arrhythmias.
   * Primary cardiomyopathies
2. Significant pulmonary disease (FEV1\<50% predicted, GOLD III-IV)
3. Inability to exercise or conditions that may interfere with exercise intervention.
4. Myocardial infarction in the last 3 months
5. Signs of ischaemia during maximal cardiopulmonary exercise test.
6. Comorbidity that may influence one-year prognosis 7. Participation in another clinical trial.

Primary outcomes:
measure: Exercise capacity
timeFrame: Change from Baseline exercise capacity at 3 months
measure: E velocity
timeFrame: Change from Baseline E velocity at 3 months
measure: Endothelial function
timeFrame: Change from Baseline endothelial function at 3 months
measure: Arterial stiffness
timeFrame: Change from Baseline arterial stiffness at 3 months
measure: A velocity
timeFrame: Change from Baseline A velocity at 3 months
measure: E/A ratio
timeFrame: Change from Baseline E/A ratio at 3 months
measure: e' velocity
timeFrame: Change from Baseline e' velocity in m/s at 3 months
measure: E/e' ratio
timeFrame: Change from Baseline E/e' ratio at 3 months
measure: ejection fraction
timeFrame: Change from Baseline ejection fraction at 3 months
measure: left ventricular volume index
timeFrame: Change from Baseline left ventricular volume index at 3 months
measure: end-diastolic volume
timeFrame: Change from Baseline end-diastolic volume at 3 months
measure: left ventricular mass
timeFrame: Change from Baseline left ventricular mass at 3 months
measure: left atrial diameter
timeFrame: Change from Baseline left atrial diameter at 3 months
measure: isovolume relaxation time
timeFrame: Change from Baseline isovolume relaxation time at 3 months
measure: deceleration time
timeFrame: Change from Baseline deceleration time at 3 months
measure: left atrial volume index
timeFrame: Change from Baseline left atrial volume index at 3 months
Secondary outcomes:
measure: Sociodemographic variables
timeFrame: Baseline
measure: Patient's medical history
timeFrame: Baseline
measure: Weight
timeFrame: Change from Baseline weight at 3 months
measure: Muscular strength
timeFrame: Change from Baseline Muscular strength at 3 months
measure: Spirometry
timeFrame: Change from Baseline spirometry at 3 months
measure: Glucose
timeFrame: Change from Baseline Glucose at 3 months
measure: Physical activity
timeFrame: Change from Baseline phisical activity at 3 months
measure: HQoL
timeFrame: Change from Baseline HQoL at 3 months
measure: Adherence to the Mediterranean diet
timeFrame: Change from Baseline Adherence to the Mediterranean diet at 3 months
measure: height
timeFrame: Change from Baseline height at 3 months
measure: BMI
timeFrame: Change from Baseline BMI at 3 months
measure: waist circumference
timeFrame: Change from Baseline waist circumference at 3 months
measure: body fat
timeFrame: Change from Baseline body fat at 3 months
measure: blood pressure
timeFrame: Change from Baseline blood pressure at 3 months
measure: total cholesterol
timeFrame: Change from Baseline total cholesterol at 6 months
measure: triglycerides
timeFrame: Change from Baseline triglycerides at 6 months
measure: HDL-cholesterol
timeFrame: Change from Baseline HDL-cholesterol at 6 months
measure: LDL-cholesterol
timeFrame: Change from Baseline LDL-cholesterol at 6 months
measure: apolipoproteins A1 and B
timeFrame: Change from Baseline apolipoproteins A1 and B at 6 months
measure: insulin
timeFrame: Change from Baseline insulin at 6 months
measure: ultra-sensitive C-reactive protein
timeFrame: Change from Baseline ultra-sensitive C-reactive protein at 6 months
measure: N-terminal pro-B-type natriuretic peptide (NT-proBNP)
timeFrame: Change from Baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 6 months
measure: HbA1c
timeFrame: Change from Baseline HbA1c at 6 months
Other outcomes:
Locations:
city: Cuenca
country: Spain
facility: Universidad de Castulla-La Mancha
Study officials:
References: